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Successful Medical Device Design Transfers Hinge on Advance Planning

by David Finch | Apr 2018 (Research & Development) ... processes and assembly instructions been documented and validated? Are all drawings and specifications complete for product, component and raw materials? Is the bill of material complete, including ... Read more »

Start Simple: Advice to Effectively Use Statistical Methods in Process Validation

by Rob Meyer | Apr 2018 (Research & Development) ... that “a process is established that can consistently conform to requirements” and “studies are conducted demonstrating” this.  How can you make the best decision? Thorough process development, optimization ... Read more »

3Diligent Expands Digital Manufacturing Services

by BONEZONE | Apr 2018 (Supplier News Items) ... and online portal beyond the scope of its 3D printing offering. 3Diligent now offers a range of services including milling, turning, electro discharge machining, water jetting and laser cutting. Casting ... Read more »

Why One Surgeon Entrepreneur is Focused on MIS, Orthobiologics and UDI

by Julie Vetalice | Apr 2018 (Voice of Industry) ... ConnectSx, an eHealth company that addresses inventory management, UDI compliance, just-in-time training/knowledge delivery, and electronic transaction capabilities delivering new efficiency and discipline ... Read more »

Evonik Launches New Composites, Intensifies Research on Regenerative Medicine

by BONEZONE | Apr 2018 (Supplier News Items) ... for medical devices (including bioresorbable RESOMER® and high-performance PEEK VESTAKEEP®), announced strategic initiatives including a new line composites and an increased focus on regenerative medicine: ... Read more »

Nelipak to Offer Freestanding Rotary Medical Tray and Blister Heat Sealers

by BONEZONE | Apr 2018 (Supplier News Items) ... suitable for Class-7 cleanroom operations. Nelipak’s machines seal a variety of coated lid materials including Tyvek®, paper, film or foil and ensure validated seals when used in conjunction with the company’s ... Read more »

Acquisitions Position NN, Inc. as Major Orthopaedic Supplier

by Rob Meyer | Apr 2018 (Business Critical) ... designs and manufactures high-precision metal and plastic components, instruments and assemblies for a variety of markets, including orthopaedics, on a global basis. The company is relocating its Johnson ... Read more »

Medical Component Specialists Introduces Mandrel Quick Ship Program

by BONEZONE | Apr 2018 (Supplier News Items) ...  MCS—an OMTEC® 2018 exhibitor—designs and manufactures medical components including mandrels, pins, medical drills and staples for orthopedic and interventional applications. MCS also possesses laser ... Read more »

Norman Noble Adds Additive Manufacturing Capabilities

by BONEZONE | Apr 2018 (Supplier News Items) ... customer needs, including shape-setting fixtures for nitinol-based rapid prototypes, prototype-to-production manufacturing for next-gen medical implant designs and the manufacture of aerospace and commercial ... Read more »

Baum Precision Machining Adds 5-Axis Machine

by BONEZONE | Apr 2018 (Supplier News Items) The company specializes in CNC milling and serves several industries, including medical. Baum Precision Machining has added a 5-Axis Machining Center, the Yasda PX30i, to its Pipersville, Pennsylvania ... Read more »

FDA and Customs Monitoring of International Purchasing: What You Need to Know

by John Gagliardi | Apr 2018 (Legal, Clinical & Regulatory) ... offices in 2008, posting staff in strategic locations around the world, including China, Europe, India and Latin America. FDA overseas offices work closely with their respective foreign governments, industries ... Read more »

Extremities Players Seek to Bolster Shoulder Revenue with Stemless Implants

by Rob Meyer | Apr 2018 (Research & Development) ... market. Though stemless shoulders are relatively new, several analysts, including Larry Biegelsen of Wells Fargo Securities, noted that the FDA clearance of the Equinoxe “will continue to grow the category.” ... Read more »

NN, Inc. Announces Definitive Agreement To Acquire Paragon Medical

by BONEZONE | Apr 2018 (Supplier News Items) ...  implants, instruments and devices for the global market, including orthopaedics. Headquartered in Johnson City, Tennessee, NN has 44 facilities in North America, Western Europe, Eastern Europe, South America and China ... Read more »

Evonik to Transform Project House into Collaborative R&D Center

by BONEZONE | Mar 2018 (Supplier News Items) The company will add to its additive manufacturing capability with this strategic investment. Evonik, a supplier of polymers (including bioresorbable RESOMER® and high-performance PEEK VESTAKEEP®) ... Read more »

Micro Machine Names Jeffrey G. Roberts President & CEO

by BONEZONE | Mar 2018 (Supplier News Items) ... surgical technology. His industry experience includes executive leadership positions in a variety of market segments, including arthroscopy/soft tissue, large and small joint replacement and trauma. Micro ... Read more »

Knee and Hip Manufacturers Focus on Additive, Materials, Robotics

by Carolyn LaWell | Mar 2018 (Voice of Industry) ... portable and cost effective, including procedure-time-neutral and reduction of instruments. “To be successful in the robotics category, we believe there are certain fundamentals that need to exist ... Read more »

Globus Medical Making Sizable Push Into Trauma Market

by Rob Meyer | Mar 2018 (Research & Development) ... where GMED displayed its growing portfolio of FDA 510(k)-cleared trauma products in four families, including fracture plates, compression screws, cannulated screws, intramedullary nails and external fixation. ... Read more »

nanoMAG Receives ISO 13485:2016 Certification

by BONEZONE | Mar 2018 (Supplier News Items) ... to the increased regulatory requirements for organizations in the supply chain. It is a major update from the 2003 standard and is designed to respond to latest quality management system practices, including ... Read more »

Innovnano and Portuguese University Partner on 3D Implant Project

by BONEZONE | Mar 2018 (Supplier News Items) ...  Researchers will work to optimize the particle shape of the zirconia-based composite materials to produce the best compromise between porosity and mechanical resistance, and also on in vitro and in vivo studies ... Read more »

NN, Inc. Acquires Bridgemedica

by BONEZONE | Mar 2018 (Supplier News Items) ... segment and expands the company’s new product design engineering and development capabilities. NN designs and manufactures high-precision components and assemblies for a variety of markets, including ... Read more »

TKRs, Associated Products Among Strategic Announcements, Launches at AAOS 2018

by Rob Meyer | Mar 2018 (Business Critical) In addition, companies including Stryker, Smith & Nephew and DePuy Synthes have launched some of their latest technologies in hip, biologics, spine and more. The American Academy of Orthopedic Surgeons’ ... Read more »

AcceLINX Adding Three Experts to Consultant Roster, Collaborating With AMB Surgical

by BONEZONE | Mar 2018 (Supplier News Items) ... of Senior Director of Manufacturing/Site Leader. He has also held many positions in product development, including that of Director of Global Development -Extremities at Zimmer. Mr. Domyhan has more ... Read more »

Vital Validation Considerations for Your Company's Next Packaging Project

by Rob Meyer | Feb 2018 (Supply Chain Management) ... larger vs. smaller companies. Not long ago, large companies were doing feasibility studies very informally with little to no documentation. Some now require full traceability, a pre-approved feasibility ... Read more »

Medical Device Packaging is Shaped by Increased Regulations

by Rob Meyer | Feb 2018 (Supply Chain Management) Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the coming years. Increased regulatory oversight is shaping medical ... Read more »

Spine, Trauma Companies Continue a Focus on Sterile Packaging

by BONEZONE | Feb 2018 (Supply Chain Management) ...  of goods low and quality standards high, says Chief Commercial Officer Ryan D. Schlotterback. Sterile packaging has offered numerous opportunities, including differentiation in the marketplace and efficienc ... Read more »

Supplier Talks: Precision, Accuracy Among Swiss Machining Benefits

by Rob Meyer | Feb 2018 (Research & Development) ... , including orthopaedic-specific bone screws (cannulated, self-drilling, polyaxial and pedicle). Norman Noble operates over 55 Swiss-style turning machines, which are located in an independent producti ... Read more »

The Contribution of Biomaterials to the Dawning of the Age of the Forgotten Hip

by Robert Poggie | Feb 2018 (Voice of Industry) ... bearing, after learning that PTFE (Teflon) was not the solution. The success of THA depends upon many factors including design, surgical technique, post-operative care and materials, with the latter arguably ... Read more »

The Medical Device Labelling Process Needs to Start Early in Design Controls

by John Gagliardi | Feb 2018 (Legal, Clinical & Regulatory) ... decision, “Most, if not all advertising, is labeling. The term ‘labeling’ is defined in the FD&C Act as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from ... Read more »

Renishaw’s SFP2 Improves Surface Measurement Ability of REVO System

by BONEZONE | Feb 2018 (Supplier News Items) ... specializes in precision measurement and additive manufacturing systems for a variety of industries, including healthcare. Source: Renishaw        ... Read more »

Surgeon Touts Benefits of Molybdenum-Rhenium in Spinal Applications

by Carolyn LaWell | Feb 2018 (Research & Development) ...  bone growth. MoRe is about 60%more wettable than titanium. We’ve done studies in which we’ve put small pieces of MoRe on rods in a rabbit femur and made it flush with the surface of the cortex. The ca ... Read more »

Are You Capturing the Right Inspection Information?

by Janis Olson | Feb 2018 (Supply Chain Management) ... the Auditing Resource Center and co-wrote the PDA technical report on computer system supplier auditing.  EduQuest can be reached by email.  EduQuest  ... Read more »

United Performance Metals Achieves ISO 9001:2015 Certification

by BONEZONE | Feb 2018 (Supplier News Items) ... a wide inventory of products, including stainless steel, duplex stainless steel, Prodec®, nickel alloys, cobalt alloys, cobalt chrome moly, titanium, aluminum and alloy steel in coil, sheet, strip, plate, ... Read more »

Total Plastics International, Restoration Medical Polymers Enter Into Distribution Agreement

by BONEZONE | Feb 2018 (Supplier News Items) ... TPI will work directly with customers on all product requirements including Type I and II, cross-linked, vitamin E and any specialty requirements of UHMWPE, as well as stocking material and vendor managed ... Read more »

UDI: Is Your System Ready for Scale?

by Carolyn LaWell | Jan 2018 (Legal, Clinical & Regulatory) UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance and disapproval. Call it a forever project, program, ... Read more »

Medilogic Gains ISO 13485/9001 Certifications

by BONEZONE | Jan 2018 (Supplier News Items) ... system practices, including changes in technology and regulatory requirements and expectations.  ISO 9001:2015 specifies requirements for a quality management system when an organization: a) needs to ... Read more »

GE Additive Opens Munich Customer Experience Center

by BONEZONE | Jan 2018 (Supplier News Items) ...  The Customer Experience Center in Munich, launched with an investment of $15 million, will employ up to 50 GE Additive employees, including technicians and engineers specializing in additive design and ... Read more »

RTI Surgical Expanding Spine Fusion Portfolio, Acquires Zyga Technology

by BONEZONE | Jan 2018 (Business Critical) ...  $100MM market in the U.S., slated to exceed $200MM by 2024, with SI joint fusion procedures growing 20%.  In September 2017, Highmark expanded positive coverage for minimally invasive sacroiliac joint fusion, includin ... Read more »

ConnectSx Launches UDidentify Mobile App

by BONEZONE | Jan 2018 (Supplier News Items) The free app scans and validates HIBCC and GS1 barcodes used for compliance with FDA unique device identification (UDI) ConnectSx, a Mokena, Illinois-based startup providing SaaS solutions that support ... Read more »

The Brazilian Market: A Regulatory Overview for Orthopaedic Products

by Juliana Ramos Gouveia | Jan 2018 (Legal, Clinical & Regulatory) ... (ANVISA) had a long waiting line to schedule GMP audits, delaying the ability of many companies to start their business in Brazil. However, in October 2017, regulation RDC 183/17 was published to change ... Read more »

Startup Aims to Monitor Joint Loosening and Infection with Implantable Sensors

by Carolyn LaWell | Jan 2018 (Research & Development) ... that up is really substantial. All the lab studies—x-rays, bone scans, MRIs—don’t give you the answer; they approximate a diagnosis. The real diagnosis is a clinical judgment. But if you can solidify parameters—for ... Read more »

Augmedics Bringing X-Ray Vision to Surgery with X-VISION Visualization System

by Rob Meyer | Jan 2018 (Research & Development) ... or and Augmedics CEO and Co-Founder Nissan Elimelech, who has ten years of experience in various medical device markets, including spine (Medtronic). Below we share his words, vision and future plans. W ... Read more »

Consensus Orthopedics’ TracPatch Targets Efficiency in Post-Op Care

by Carolyn LaWell | Jan 2018 (Research & Development) ... 2017, and will launch TracPatch ACL and a demo of TracPatch Hip at the 2018 AAOS meeting. The company’s pipeline includes applications in multiple orthopaedic specialties, including shoulder and elbow. ... Read more »

Be Prepared When Suppliers are Acquired

by David Finch | Jan 2018 (Supply Chain Management) ... components, instruments and implants, including process and inspection technique. Required approval or minimal notification for all process and country of origin changes with minimum time requirement ... Read more »

Arcam EBM Expanding Into New Facility

by BONEZONE | Jan 2018 (Supplier News Items) ... M component. In 2016, Arcam was part of GE Additive’s U.S. $1.4BB investment in additive technology, materials and services worldwide. Arcam then took numerous strategic steps to expand in 2017, including:  ... Read more »

Study: Rotation Medical Bioinductive Implant Promotes Consistent Rotator Cuff Healing, Mitigates Tear Progression

by BONEZONE | Dec 2017 (Research & Development) ...  12-month results including:  Significant improvement in clinical scores, with mean tendon thickness increased by 2mm, and new tissue indistinguishable from underlying tendon 94% of patients showin ... Read more »

MedTech Momentum Launches Video Production Studio

by BONEZONE | Dec 2017 (Supplier News Items) The venture covers a wide range of video formats for medical companies to choose from. MedTech Momentum's new video production studio is dedicated to serving medical companies around the globe. Th ... Read more »

J-Pac Medical Receives ISO:13485:2016 Registration Ahead of Schedule

by BONEZONE | Dec 2017 (Supplier News Items) ... for organizations in the supply chain. It is a major update from the 2003 standard and is designed to respond to latest quality management system practices, including changes in technology and regulatory ... Read more »

Computational Modeling and Simulation Expanding in Orthopaedic Device Life Cycles

by Marc Horner, Ph.D. & Mehul Dharia | Dec 2017 (Research & Development) ... for Computational Modeling As shown in the previous section, CM&S studies are an integral part of the total product life cycle of orthopaedic implants that can provide significant benefits to the device ... Read more »

Examining Methods to Determine Sample Sizes

by Deborah Munro | Dec 2017 (Legal, Clinical & Regulatory) ... an intervention is deemed necessary (probability) PL—lower threshold beyond which an intervention is deemed unnecessary (probability) α—Type I error of concluding lot is acceptable when it is not, ... Read more »

Why a Well-Conceived Test Plan is Crucial to Efficient Product Development

by Robert Poggie | Dec 2017 (Legal, Clinical & Regulatory) ... FDA guidance documents (including those associated with safety such as validation-test requirements for cleaning of reusable instruments), sterilization of products, shipping and handling and shelf life. ... Read more »

Magnus René and Johan Brandt (CEO and CFO) Announce Plans to Leave Arcam

by BONEZONE | Dec 2017 (Supplier News Items) ... was relocated to the U.S. Subsequently, Brandt was appointed Executive Vice President and CFO of Arcam. In the past year alone, Arcam has taken numerous strategic steps to expand, including: Spin-out ... Read more »

Learn to Incorporate Sensors Into Your Next Design Idea

by Deborah Munro | Dec 2017 (Research & Development) ... it’s exposed. The shape and depth of the etch depend on several factors, including obvious ones like time and the chemical used, and not-so-obvious ones like the crystal orientation in your chosen wafer. ... Read more »

Sanford Health Stem Cell Therapy Trial First in U.S. for Shoulder Injuries

by Rob Meyer | Dec 2017 (Research & Development) ...  If so, enrollment in that trial will begin in 2018. Dr. Pearce said Sanford Health considered other types of orthopaedic injuries for its proposal, including osteoarthritis and knee, hip, wrist and bac ... Read more »

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

by John Gagliardi | Dec 2017 (Legal, Clinical & Regulatory) ... were slow to adopt the Medical Device Single Audit Program (MDSAP) in its pilot days, the initiative has gained traction since FDA’s Center for Devices and Radiological Health (CDRH) named it an official ... Read more »

Understanding the Critical Differences Between Supplier Audit and Evaluations

by Martin Browning | Dec 2017 (Supply Chain Management) Martin Browning from EduQuest provides insight on evaluations and audits: "All of us who conduct audits recognize that most of them are nothing more than snapshots in time. In contrast, an evaluation gather ... Read more »

Concept Laser, GE Break Ground on 3D Printing Campus

by BONEZONE | Dec 2017 (Supplier News Items) ... dental customers. The company is headquartered in Lichtenfels, with >200 employees throughout operations including Texas and China and a global network of >35 distributors and agents. GE has invested ... Read more »

UDI Direct Marking Guidance Finalized by FDA

by Rob Meyer | Nov 2017 (Legal, Clinical & Regulatory) ... recently finalized guidance on direct marking a medical device with unique device identification (UDI), providing orthopaedic manufacturers with an unsurprising position on marking methods and identical ... Read more »

Invibio Makes Series of Investments to Drive Clinical Outcome Improvement

by BONEZONE | Nov 2017 (Supplier News Items) The investments include faster time-to-market for devices through streamlined device-development strategies that consider the total costs of care. Invibio, global provider of PEEK-OPTIMA polymers to ... Read more »

Smith & Nephew's NAVIO Used in Bi-Cruciate Retaining Total Knee Replacement

by BONEZONE | Nov 2017 (Research & Development) ... and ligament balance and offers robotics-assisted bone preparation, removing bone identified by the surgeon's patient-specific plan. NAVIO is now available in partial and total knee options, includin ... Read more »

Teleflex Medical OEM Announces New Suture Technology

by BONEZONE | Nov 2017 (Supplier News Items) ... including the use of allograft tissue for orthopaedic procedures. It’s offered in USP suture sizes 1 to 5 and available in several color and pattern options. Source: Teleflex Medical    ... Read more »

5 Steps to a Collaborative Supplier Agreement

by Kate Vitasek | Nov 2017 (Supply Chain Management) ... contract is signed. Simply put, this means defining the governance mechanisms that parties will use to help them “Live as We.”    Including governance in a formal contract is essential, because relationships ... Read more »

Smith & Nephew Adds to Sports Medicine Portfolio with Rotation Medical Acquisition

by Rob Meyer | Nov 2017 (Business Critical) ... in the arthroscopy/soft tissue space, including ArthroCare in 2014 and BST-CarGel’s cartilage repair product in 2016. The Rotation Medical acquisition follows the announcement that SNN CEO Olivier Bohuon ... Read more »

Examining Critical Trends in Trauma Surgery

by Carolyn LaWell | Nov 2017 (Voice of Industry) ... weight-bearing after [surgery]. Infection Prevention Dr. McKee: Infection is becoming an extremely significant concern in multiple areas of orthopaedic trauma, including occurrence of acute infections ... Read more »

AAOS to Launch Orthopaedic Registries, Integrate With AJRR

by Rob Meyer | Nov 2017 (Business Critical) ... organizations have developed registries, including the North American Spine Society, Orthopaedic Trauma Association and AdvaMed. As AAOS makes further announcements, it will be interesting to watch whether ... Read more »

CoorsTek Medical Announces First Human Implantation of New Sacroiliac Fusion System

by BONEZONE | Oct 2017 (Supplier News Items) ...  The Integrity-SI Fusion system embraces the principles of arthrodesis, including thorough joint preparation, compression and stability via the proprietary instrumentation. It also utilizes proprietary ... Read more »

3D Printing, Expandable Cages Popular Among Pre-NASS Product Launches

by BONEZONE | Oct 2017 (Business Critical) ... ® growing rods with the RELINE® Small Stature pediatric deformity fixation system. The company also received expanded FDA 510(k) clearance of the TLX™ interbody fusion system, including an expandable 2 ... Read more »

Smith & Nephew CEO Announces 2018 Retirement; Acquisition Buzz Returns

by BONEZONE | Oct 2017 (Business Critical) ... ious distributors in geographic regions like Brazil, Columbia, Russia, Turkey, etc. SNN was also itself the subject of multiple acquisition rumors from 2011 to the present, including reported over ... Read more »

Minnesota Rubber and Plastics Doubles Clean Room Manufacturing Capacity

by BONEZONE | Oct 2017 (Supplier News Items) ... operations, including the addition of new cleaning and packaging equipment. Minnesota Rubber and Plastics provides high performance elastomers and thermoplastics to the medical device industry. Source: ... Read more »

Grace College and OrthoWorx Update Orthopaedic Graduate Studies Program

by BONEZONE | Oct 2017 (Supplier News Items) After six years of successful operation and more than 100 graduates of ORCA, it was time to revise the program. Grace College and OrthoWorx have launched an updated curriculum for their collaborative ... Read more »

Coatings Support Early Integration, Infection Prevention

by Carolyn LaWell | Oct 2017 (Voice of Industry) ... me been able to generate coatings that are osteoconductive and have osteostimulatory characteristics. Our more recent work shows that coatings can also have other very attractive attributes, including  ... Read more »

Your EU Medical Device Regulation Guide

by Deborah Munro | Oct 2017 (Legal, Clinical & Regulatory) ... Medical Devices Background The European Single Market has 28 Member States of the European Union (including the U.K.), the European Economic Area (Liechtenstein, Norway and Iceland) and Switzerland (through ... Read more »

Quebec: Orthopaedic Innovation Hub

by Robert Poggie | Oct 2017 (Voice of Industry) ... at École de technologie supérieure (ETS, engineering school, University of Quebec), Montreal is home to more than a handful of research labs, including the National Research Council of Canada, whose past ... Read more »

NuVasive Founder Talks Minimally Invasive Surgery

by Carolyn LaWell | Oct 2017 (Voice of Industry) ... disc thermal modulation, or “cooked discs”?). In my opinion, the theory and science was lacking or incomplete at best, and the advocates as well as the audience were insufficiently objective and lacked ... Read more »

CAPA Notes from an FDA Inspection

by John Gagliardi | Oct 2017 (Legal, Clinical & Regulatory) ... just a “participant” in the general scheme of compliance architecture. Some examples include: CAPA gets top management’s attention at Management Review. Quality audits and corrective actions taken are ... Read more »

NN, Inc. To Relocate Global Headquarters

by BONEZONE | Sep 2017 (Supplier News Items) ... for a variety of markets, including orthopaedics, on a global basis. Its 33 manufacturing plants are located throughout North America, Western Europe, Eastern Europe, South America and China, with specific ... Read more »

Collagen Solutions Announces Completion of Assessments in ChondroMimetic Study

by BONEZONE | Sep 2017 (Supplier News Items) ... in the knee. With the last patient enrolled, data is being compiled and audited for submission as part of a package for regulatory approval and re-establishment of the CE mark, with ex-U.S. commercialization ... Read more »

Spine Companies $100MM to $2BB: Strategic Activity Update

by Julie Vetalice | Sep 2017 (Business Critical) ... ’s vertebral augmentation business, including all AVAmax, AVAflex, AVAtex and AVAprep branded products. Stryker’s Mako robotics technology hasn’t broken out of joint recon yet, though it’s certainly reasona ... Read more »

Centinel Spine to Acquire DePuy Synthes prodisc Assets

by Carolyn LaWell | Sep 2017 (Research & Development) ... U.S. clinical studies to secure approval for other products in the portfolio. The Viscogliosi Bros. have a history with the technology, having purchased prodisc-L from Aesculap in 1999 which was then ... Read more »

Zimmer Biomet Launches Persona Partial Knee

by BONEZONE | Sep 2017 (Research & Development) ...  for use with partial knees. In mid-2Q, ZBH entered into a license agreement for use of patent families supporting technology created by Dr. Peter Bonutti, including patents that address robotic unicompartmental ... Read more »

Additive Manufacturing Evidence: Industry Advances the Dialogue

by Carolyn LaWell | Sep 2017 (Voice of Industry) A new white paper produced by the Society of Manufacturing Engineers’ (SME) Medical Additive Manufacturing/3D Printing Workgroup offers an evidence-building framework that may be used to conduct studies ... Read more »

Orthopaedic Pediatric Market Attracts New Products and Players

by BONEZONE | Sep 2017 (Business Critical) ... a new brand to house its collection of products and services (apps, games, education tools) that treat pediatric orthopaedic and congenital deformities, including the TL HEX TrueLok Hexapod system and ... Read more »

CMS Proposes Total Joint Bundled Payment, Outpatient Payment Changes

by BONEZONE | Aug 2017 (Business Critical) ... for Comprehensive Care for Joint Replacement and including ambulatory surgical centers for knee replacement. The Centers for Medicare & Medicaid Services (CMS) recently released two proposals related ... Read more »

MTD is an Inc. 5000 Fastest-Growing Company

by BONEZONE | Aug 2017 (Supplier News Items) ... factors contributed to MTD's growth, including payoff from long-term projects that moved from pipeline to production and the achievement of ISO 13485 Certification in 2016. MTD Micro Molding provide ... Read more »

Globus Medical Receives Clearance for Excelsius GPS

by BONEZONE | Aug 2017 (Research & Development) Globus Medical received FDA 510(k) clearance to market their robotic guidance and navigation system, supporting minimally invasive or open orthopaedic procedures including screw placement in spine and ... Read more »

EIT Acquires 3D-Printed Spine Patents

by BONEZONE | Aug 2017 (Business Critical) ... based on these patents will launch in 2018. The patents address multiple geographies, including the U.S. and Europe, and are based on "living hinge" designs by Morgan P. Lorio, M.D. EIT's additively-manufactur ... Read more »

Alphatec Spine Set for Rebuilding

by BONEZONE | Aug 2017 (Business Critical) Alphatec Spine posted 2Q17 revenue of $24.4MM, -24.4% vs. 2Q16, and 1H17 revenue of $52.4MM, -21.2% vs. 1H16. Though revenues continue to underperform vs. the prior year, leadership sees substantial opportunities ... Read more »

The Fused and the Fractured: New Entrants to U.S. Spine and Trauma

by Julie Vetalice | Aug 2017 (Legal, Clinical & Regulatory) ...  Used in >10,000 cases in >15 countries, including Australia, France, Germany, Korea and the Netherlands Developing 3D-printed patient specific implants to treat complex spinal disorders; first procedur ... Read more »

DePuy Synthes Launches Distal Radius Sterile Kit

by BONEZONE | Aug 2017 (Research & Development) ... s occur each year in the U.S., spanning both sexes and all ages, and that wrist fracture is one of the most common fractures presenting in the ER in patients under 65. Studies have indicated that surgic ... Read more »

Robotics, 3D Printing Gain Larger Adoption with Globus Medical, K2M Acquisitions

by Julie Vetalice | Aug 2017 (Research & Development) ... technology and corporate structure as well as oversee global commercial activity and ops (including IT and RA/QA responsibilities—they’re firming up their foundations).    Mazor’s unifying R&D and ... Read more »

3D-Printed Model Reduces Surgery Time, Cost

by BONEZONE | Aug 2017 (Research & Development) ... the Journal of Children’s Orthopaedics, including ten patients undergoing treatment for slipped capital femoral epiphysis in the study. In five of the procedures, 3D-printed models were used to prepare, ... Read more »

The Joint Surgeon's Wish List

by Julie Vetalice | Aug 2017 (Voice of Industry) ... practice he performs primary hip and knee arthroplasties, including complex revisions—fueling his research focus on biophysical disruption of biofilms in total joint arthroplasty and the care of patients ... Read more »

Design Validation: More than Just User Testing

by BONEZONE | Aug 2017 (Research & Development) ...    “While testing is always a part of validation, additional validation methods are often used in conjunction with testing, including analysis and inspection methods, compilation of relevant scientific ... Read more »

Trauma and Spine Gain New Players with First 510(k)s in 1H17

by BONEZONE | Aug 2017 (Legal, Clinical & Regulatory) ... including degenerative disc disease, spondylolisthesis, trauma and spinal stenosis Radicle Orthopaedics | New York, New York, USA | Founded 2012 Segment: Trauma K161334, RASL Repair ... Read more »

Improve Your Performance With These Tips

by Carolyn LaWell | Aug 2017 (Business Critical) ... y real constant in your life is you. Moore outlined critical aspects for us as individuals to improve our performance, including how to remain engaged in our work, how to react to other’s behavior a ... Read more »

Spine Fusion Stimulated by Sugar-Coated Nanomaterial

by BONEZONE | Jul 2017 (Research & Development) ... animal model, researchers studied the effect of sugar-coated nanomaterial on the activity of bone morphogenetic protein 2 (BMP-2). By incorporating the nanomaterial, which was delivered on a collagen sponge, ... Read more »

Tegra Medical Names New General Manager

by BONEZONE | Jul 2017 (Supplier News Items) ... in Franklin, Massachusetts. Mr. Rieth is a Six Sigma Black Belt with more than 25 years of management experience in several industries across several functions, including engineering, manufacturing, ... Read more »

Cadence Rhode Island Facility Earns Worksite Health Award

by BONEZONE | Jul 2017 (Supplier News Items) ...  Cadence has four U.S. facilities with nearly 500 employees. The company presently seeks to fill numerous positions, including CNC Techs, Machine Operators, Tool & Die Maker, Tooling Engineer, etc. Visi ... Read more »

DEKRA Expands Lab for Material Testing and Damage Analysis

by BONEZONE | Jul 2017 (Supplier News Items) ... ith a new field emissions scanning electron microscope (SEM). The SEM offers in-depth insights with applications including fractured surface investigations, surface characterization and residue identification.  ... Read more »

Renishaw Contributes Additive Manufacturing Technology to Canadian Medical Design Center

by BONEZONE | Jul 2017 (Supplier News Items) ... and surgical instruments, including joint replacement devices, cutting jigs and surgical guides. ADEISS is pursuing ISO 13485 accreditation in the U.S., Canada and Europe. Source: Renishaw  ... Read more »

Renishaw Supports Engineers of the Future

by BONEZONE | Jul 2017 (Supplier News Items) Renishaw offers an extensive education outreach program including 139 STEM ambassadors who support a variety of STEM activities with local schools.    In support of education that will impact the engineering ... Read more »