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Articles Tagged "spine"

NASS Conversations Reaffirm Focus on Additive, Computer-Assisted Surgery, Materials

by BONEZONE | Oct 2018

The spine industry is fixated on two concepts: procedure enhancement via surgical assistance technologies and device design via coatings, materials and manufacturing.... Read more »

Large Spine Players Focus Acquisitions on Robotics, Navigation, Additive

by BONEZONE | Sep 2018

Medtronic, DePuy Synthes, Stryker and Globus Medical—four of the five largest spine companies ranked by revenue—announced acquisitions in the last month. We recap the additions to their product portfolios.... Read more »

NASS Preview: 14 Spine Products That Caught Our Attention

by BONEZONE | Sep 2018

Between now and NASS 2018, we expect to hear more about new spine products that use additive manufacturing, more variations on PEEK and titanium and more expandable interbody designs. The 14 companies highlighted are already on board.... Read more »

Musculoskeletal New Ventures Conference Offers Insights on Funding, Startups

by BONEZONE | Sep 2018

Orthopaedic professionals can expect to hear about technologies being commercialized by 22 companies along with insight from long-term investors during the conference, held October 23-24 in Memphis, Tennessee.... Read more »

Stryker Moves to Strengthen Spine Business with $1.4 Billion Purchase of K2M

by BONEZONE | Sep 2018

K2M’s innovative technology platform will add a suite of complex spine solutions to Stryker’s core spine portfolio; K2M’s consistent support of additive manufacturing of devices could also benefit Stryker’s long-term growth.... Read more »

HAPPE Spine Latest Company to Manufacture PEEK Devices in Novel Ways

by BONEZONE | Aug 2018

The company was formed by Genesis Innovation Group with investments from cultivate(MD) Capital Funds I and II, and is based on the work of Ryan K. Roeder, Ph.D., and researchers from the University of Notre Dame that began over 10 years ago.... Read more »

Cerapedics Enrolls Patients in P-15L Peptide-Enhanced Bone Graft IDE Trial

by BONEZONE | Aug 2018

P-15L graft, a substitute for autologous bone, is based on synthetic small peptide technology and was developed to spur bone growth via cell attraction, attachment and activation. Cerapedics has enrolled the first of 364 patients in this IDE clinical trial.... Read more »

Spinal Cages Continue Trend Toward Metals, Expandable Designs

by BONEZONE | Aug 2018

"Cage design has been a game changer in spine surgery." Three veteran spine surgeons provide insight into the shift to titanium, a forecast for the next five years in cage technology and thoughts on device companies' priorities.... Read more »

Year-to-Date Funding Recap: Robotics, Imaging, ACL Implant, Cervical Disc and More

by BONEZONE | Jul 2018

These funding announcements feature technologies related to each of the market segments: spine, trauma, arthroscopy/soft tissue, joint reconstruction and orthobiologics.... Read more »

12 Growing Orthopaedic Companies Expand Their Patent Portfolios

by BONEZONE | Jul 2018

A review of patent activity in 1H18 shows technological innovations from companies like Episurf, iOrthopedics, Orthocell and Spineology across arthroscopy/soft tissue repair, joint reconstruction, orthobiologics, spine and trauma.... Read more »

Spine, Joint Recon Product Launches Focus of Top Orthopaedic Companies

by Julie Vetalice | Jun 2018

The 1H18 product launches by the top orthopaedic companies were largely focused on the market segments of spine and joint reconstruction. We offer a list of new products and their descriptions. ... Read more »

FDA 510(k) Highlights: Five Companies Gain First Orthopaedic Clearances

by Julie Vetalice | Jun 2018

To provide insight on new competitors entering the U.S. orthopaedic market, we offer details on five companies and their first orthopaedic FDA 510(k) clearances.... Read more »

Robotics in Orthopaedic Surgery: Answers to Three Questions

by BONEZONE | May 2018

We examine the players and products, address data and adoption, and look at who is driving the push toward the technology.... Read more »

Meddux Development Names New Partners

by BONEZONE | May 2018

Chad Herremans and Nathan White join the company in VP roles.... Read more »

coflex Gains Disposable Instrument PMA, NASS Coverage Policy Recommendation

by BONEZONE | May 2018

These two developments could assist Paradigm Spine in adoption of its novel product that has faced reimbursement hurdles.... Read more »

Orthopaedic Industry Reaches $49.3 Billion, Grows 3.7%

by BONEZONE | May 2018

Of note is the growth of the 20 largest orthopaedic device companies, which combined comprise 76% of the market.... Read more »

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

by BONEZONE | Apr 2018

Patrick Sweeney, M.D. is Founder of the Center for Minimally Invasive Surgery, an ambulatory surgery center in Illinois that addresses a range of orthopaedic and spinal conditions. He is also an inventor/entrepreneur, holing 30+ U.S. and European patents.... Read more »

Spine, Trauma Companies Continue a Focus on Sterile Packaging

by BONEZONE | Mar 2018

Increased infection rates at hospitals, regulatory implications on cleaning and the efforts of hospitals to cut costs have all driven sterilization changes in device packaging.... Read more »

Surgeon Touts Benefits of Molybdenum-Rhenium in Spinal Applications

by BONEZONE | Feb 2018

Dr. Kornelis Poelstra's researcn shows that molybdenum-rhenium (MoRe) offers greater strength in smaller implants compared to cobalt-chrome, titanium and stainless steel.... Read more »

RTI Surgical Expanding Spine Fusion Portfolio, Acquires Zyga Technology

by BONEZONE | Jan 2018

Zyga Technology is the developer of the SImmetry® Sacroiliac Joint Fusion system.... Read more »

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

by BONEZONE | Jan 2018

With its first application in minimally invasive spine procedures, X-VISION technology is designed to save time during surgery, reduce radiation exposure and reduce the number of repeat operations and hospitalizations.... Read more »

Omnia Medical Gains FDA Clearance for PEEK-OPTIMA HA VBR

by BONEZONE | Dec 2017

This is reportedly the first PEEK-OPTIMA HA vertebral body replacement to receive FDA clearance.... Read more »

Antibacterial Benefits of PEKK Detailed in Study of 3D-Printed OsteoFab Structures

by BONEZONE | Dec 2017

Oxford Performance Materials says that study results reveal superior antibacterial properties of PEKK structures compared to PEEK surfaces.... Read more »

Forward Momentum Continues in Artificial Discs

by BONEZONE | Dec 2017

We highlight recent clinical trial results, a procedural milestone and a device launch.... Read more »

Spine Companies Target New Applications of PEEK and Metals for Implant Innovation

by BONEZONE | Nov 2017

In response to spine surgeons’ shift away from traditional PEEK cages, materials were (again) one of the main themes discussed at the North American Spine Society Annual Meeting. At NASS, we sat down with representatives of companies promoting osteoconductive PEEK and molybdenum-rhenium.... Read more »

CoorsTek Medical Announces First Human Implantation of New Sacroiliac Fusion System

by BONEZONE | Oct 2017

The system received FDA 510(k) clearance in December 2016.... Read more »

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

by BONEZONE | Oct 2017

Companies announced numerous spine product regulatory decisions and market launches well in advance of the 2017 NASS Annual Meeting. We've recapped product updates as a guide for what you can see and hear about on the exhibit floor.... Read more »

NuVasive Founder Talks Minimally Invasive Surgery

by BONEZONE | Oct 2017

Minimally invasive surgical (MIS) products are a staple of today’s spine company portfolios. In anticipation of new devices to be launched at the NASS Annual Meeting, we asked James F. Marino, M.D. about the technologies.... Read more »

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

by BONEZONE | Sep 2017

The majority of the spine market—just about 80%—is controlled by companies with annual spine revenue above $100 million. We highlight nine of these companies here.... Read more »

NASS: Supplier Company Exhibitors Grow 50% in 5 Years

by BONEZONE | Sep 2017

Nearly 100 suppliers are expected to exhibit at NASS 2017. As you decide whom to meet with on the exhibit floor, we thought you might have the same question we did for these companies: Why?... Read more »

Innovation in Spine: Suppliers and Service Providers Weigh In

by BONEZONE | Sep 2017

In preparation for attending the NASS Annual Meeting in October, we took time to speak to supplier and service provider companies to get a read on current trends and future advancements in spine.... Read more »

Centinel Spine to Acquire DePuy Synthes prodisc Assets

by BONEZONE | Sep 2017

Centinel Spine has entered into an agreement to purchase DePuy Synthes’ worldwide prodisc assets. The acquisition is expected to close in mid-4Q17. Terms were not disclosed.... Read more »

Medtronic Assumes Exclusive Commercial Rights for Mazor X

by BONEZONE | Sep 2017

Medtronic entered Phase II of its strategic partnership with Mazor Robotics, granting Medtronic exclusive global distribution of the Mazor X surgical robotic assistance platform. The partnership affords Medtronic the lead in robotics amongst the largest spine players.... Read more »

Globus Medical Receives Clearance for Excelsius GPS

by BONEZONE | Aug 2017

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 orthopaedic surgery.... Read more »

Alphatec Spine Set for Rebuilding

by BONEZONE | Aug 2017

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 for turnaround.... Read more »

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

by Julie Vetalice | Aug 2017

Globus Medical has received clearance for its first two trauma products. While they prepare to enter that space, numerous competitors are bringing out interbody fusion devices for introduction in U.S.   ... Read more »

Hip and Spine: New Players Receive FDA 510(k)s

by BONEZONE | Jul 2017

Of the 56 orthopaedic-related 510(k)s that FDA released in June, we share observations and insights on two total hips, one interbody fusion system and a pedicle screw system.... Read more »

May 510(k) Review: New Players in SI Joint Fusion, Hip Recon

by BONEZONE | Jun 2017

Of 56 products gaining clearance under FDA's Orthopedic Panel in May, we highlight the following four: a locking plate, next-gen meniscus repair implant, SI joint fusion device and new total hip.... Read more »

3D Systems Releases Simbionix SPINE Mentor

by BONEZONE | Jun 2017

3D Systems released Simbionix SPINE Mentor, a hands-on simulated training and practice tool for minimally invasive spine surgeries.... Read more »

R&D Recap: Leading Orthopaedic Device Company Product Initiatives

by BONEZONE | Jun 2017

Acquisitions, divestitures, market entries and exits have contributed to the shaping of product portfolios of the orthopaedic industry’s larger players, in recent years. We review their product development initiatives over the last 18 months to offer a good look at your competitors’ strateg... Read more »

Orthopaedic Industry Revenue Reaches $48.1 Billion

by BONEZONE | May 2017

Orthopaedic industry revenue reached $48.1 billion worldwide in 2016 and grew at 3.2%, ~$1.5 billion over 2015, according to our estimates published in the ORTHOPAEDIC INDUSTRY ANNUAL REPORT®. ... Read more »

Exactech Divests Spine Assets

by BONEZONE | Mar 2017

ChoiceSpine expands breadth of product and global distribution with acquisition.... Read more »

Clinical Data: A Snapshot of Recent Announcements

by BONEZONE | Nov 2016

Your surgeon and hospital customers will continue to demand clinical and economic data, no matter the type of implant or the size of your company. Wherever your responsibilities lie within your company, it’s important to consider how your work contributes to better patient outcomes, and know ... Read more »

Spine Company 510(k)s from 1H16

by Julie Vetalice | Oct 2016

Not all spine companies attend NASS! Get to know ten recipients of their first FDA 510(k) clearances to see what technologies they’re offering.... Read more »

Five Questions with Dr. Christopher Bono, NASS President

by BONEZONE | Oct 2016

In preparation for NASS, we spoke with Executive Director and CEO Eric Muehlbauer and Christopher M. Bono, M.D., President of NASS. Both discussed reimbursement matters—a concern for surgeons and device manufacturers alike. What else was on the President’s mind?... Read more »

Spinal Fusion Device in Development Eliminates Bone Graft and Pedicle Screws

by Hannah Corcoran | Oct 2016

Researchers at The University of New South Wales developed a fusion device designed to stabilize the spine without bone graft or pedicle screws in single-level posterolateral fusion.... Read more »

Jarvis Surgical Honored With State Economic Impact Award

by BONEZONE | Oct 2016

During 2015, the company invested $1.7 million in a 15,000-square-foot facility and supported the creation of 15 new jobs.... Read more »

NASS Preview: Growing Spine - International Markets, MIS and Product Portfolios

by BONEZONE | Sep 2016

In speaking with Eric Muehlbauer, Executive Director and CEO of NASS about the Society's priorities, as well as where the greatest opportunities lie for surgeons and device companies, three topics arose.... Read more »

Promimic Secures Funding to Support U.S. Market Entry

by BONEZONE | Sep 2016

Approximately $3.2MM will support establishment of commercial operations in Austin, Texas.... Read more »

Reimbursement in Spine: A NASS Priority

by Julie Vetalice | Sep 2016

In order for commercialization to succeed, everyone needs to be paid. Be proactive for you and your customers by making reimbursement a part of your development timeline.... Read more »

NASS Preview: Suppliers to Build your Orthopaedic Products

by BONEZONE | Aug 2016

NASS 2016 welcomes more than 70 suppliers to its exhibit floor. Use this list to identify your next new partner.... Read more »

Medtronic, Zimmer Biomet Enter 2-level Cervical Disc and Robotic Markets

by Carolyn LaWell | Aug 2016

In efforts to invigorate revenue growth, Medtronic and Zimmer Biomet have focused on niche technologies that expand their portfolios—but have yet to prove wide scale adoption.... Read more »

3 Points to Consider from the Long-Awaited EU Medical Device Regulations

by BONEZONE | Jul 2016

The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe.... Read more »

LDR Partners with Poly-Shape to Build Spinal Implants With Additive Manufacturing

by BONEZONE | Jan 2016

Poly-Shape, a French manufacturing company specializing in laser sintering, entered into an exclusive agreement with LDR. The agreement combines LDR’s spinal focus and approach to implant design with Poly-Shape’s proprietary, additive manufacturing methods. The agreement was signed in 4... Read more »

NASS Recap: Surface-treated, 3D-printed Cages among New Launches in Interbody Space

by Carolyn LaWell | Nov 2015

Spine companies continue to focus on surface treatments and new manufacturing processes to support more solid fusions.... Read more »

Zoning In With LDR’s Christophe Lavigne

by BONEZONE | Sep 2015

Christophe Lavigne, CEO and President of LDR, spoke to BONEZONE on the direction of his company, highlighting strategies for growth.... Read more »

Three Spine Companies Implement New Manufacturing Strategies

by Carolyn LaWell | Sep 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

ECA Medical Instruments Develops 1st Disposable Spinal Instrument Fixation Kit to Gain FDA Clearance with Intelligent Implant Systems

by BONEZONE | Jan 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Zoning In with Mark Augusti

by BONEZONE | Dec 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

21 Notable Products from 2014

by BONEZONE | Dec 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

ECA Medical Instruments and Intelligent Implant Systems Unveil World’s 1st Pre-Sterile, Single-Procedure Spinal Fusion Kit

by BONEZONE | Nov 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Preparation for Spinal Reclassification Under Way, Despite Pending EU Regulations

by Carolyn LaWell | Nov 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Spine Product Launches in 2014

by BONEZONE | Oct 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Surgeons Share Spine Device Trends and Challenges

by Hannah Corcoran | Oct 2014

Spine surgeons discuss trends that excite them, their biggest challenges when using devices and what they want you to know when working with them to collectively improve spinal care.... Read more »

3D Printed Spinal Implants to be Produced By U.K. Dental Lab

by BONEZONE | May 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Japan: Entering an Established Market

by BONEZONE | Dec 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Start Early: Converting Your Spinal Technical File into a Class III Design Dossier

by Robert Packard | Dec 2013

As part of EU Commission regulatory changes, spinal implants will be reclassified from Class IIb devices to Class III devices. OEMs with spinal implants on the market should be proactive and start planning for reclassification now.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Nov 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Oct 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Aug 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Looking Back at INFUSE: 2002 to Today

by BONEZONE | Aug 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Sharp Rise in Use of Bone Growth Factor for Spinal Fusion Surgery

by BONEZONE | Mar 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Company Financials: Orthopaedic and Spine

by BONEZONE | Sep 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

1Q11 Company Financials: Orthopaedic and Spine

by BONEZONE | Aug 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

2010 Company Financials: Orthopaedic and Spine

by BONEZONE | Mar 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

3Q10 Company Financials: Orthopaedic and Spine

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

2010 Orthopaedic Year in Review, Positive Signs for 2011

by BONEZONE | Dec 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Enter 2010 and Leave Fear Behind

by BONEZONE | Mar 2010

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »