Products highlighted here — representing the spine, joint reconstruction, trauma and arthroscopy/soft tissue segments — include a total hip, cervical plate, interbody fusion system, lumbar fusion system, spacer, pedicle screw systems and more. ... Read more »
This more modern 510(k) pathway is to be used for clearance of low- to moderate-risk devices. It has a focus on predicate devices that are 10 years old or less, and its framework is aimed at efficiently advancing beneficial technology to patients while keeping with FDA’s standards for safety and e... Read more »
What else did you read about the most on our website last year? Arthroscopy/soft tissues companies to watch; products in spine, knee and hip; surgeon perspectives on implant material choice; supply chain quality; labelling mistakes, Brazil and more. ... Read more »
Several of these clearances reflect additions of stemless/short stem, glenoid components and reverse applications, as well as additively-manufactured and porous/porous-coated designs, allowing companies to offer a wider array of products. ... Read more »
Considering surgical techniques, regulations and technologies together as a whole, expect to see significant changes in orthopaedics over the next decade. Here we present seven shifts that OEMs should consider when choosing new product development initiatives.... Read more »
Flex-Cell is a contract manufacturer of orthopaedic implants and surgical components.... Read more »
Common challenges device company engineers face during validation of delivery systems include case/tray longevity, robustness of design, maintaining integrity of ID markings and establishment of worst-case testing parameters. ... Read more »
Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are in control of the situation and are attempting to comply voluntarily by doing everything possible and reasonable to ensure that your products meet Agency specifications."... Read more »
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 »
Kapstone Medical is a product development service provider and medical device engineering firm.... Read more »
This certification is part of the company’s continuing efforts to upgrade its Quality Management System.... Read more »
We provide a recap of how companies including Additive Orthopedics, Arthrex, Corin, DJO, Exactech, Orthofix, Wright Medical, Zimmer Biomet and more are supporting new product launches and maintaining their growth.... Read more »
An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the insight provided: "Have a good process flow map of all of the steps involved. People tend to focus on the printing portion, but there are a number of steps upstream and... Read more »
Active Implants is pursuing an FDA De Novo 510(k) clearance for the device. If cleared, NUsurface would be the first “artificial meniscus.” ... Read more »
In this installment, supply chain experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet discuss customer differentiation, building partnerships, regulatory challenges and continuous improvement efforts. ... Read more »
No matter where you are in the design process and no matter your internal procedures, control and documentation of design change is critical for safe and effective products.... Read more »
The company stated disagreement with certain aspects of some of the technical CAPA topics, based on perceived misunderstanding on behalf of the investigators, a lack of context and incomplete information reported by company representatives.... Read more »
Medical imaging diagnostic group Imagen Technologies created OsteoDetect software, which identifies fractures in x-rays using an AI algorithm to analyze images.... Read more »
These two developments could assist Paradigm Spine in adoption of its novel product that has faced reimbursement hurdles.... Read more »
The session aimed to collaboratively explore U.S. device regulations and offer high-level knowledge about the FDA review process.... Read more »
This will allow NN Life Sciences to sell more of its products into new markets using its existing regulatory program.... Read more »
The iOS-native mobile app brings transparency to the surgical supply chain by helping users schedule cases, manage inventory, track UDI data and generate billing documents.... Read more »
The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe and effective for human use. ... Read more »
Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the coming years.... Read more »
Common problems that OEMs face during packaging validation include determining what validations are actually necessary, understanding all timelines and costs associated with each validation type and re-executing if validation fails. ... Read more »
The rule amends that inspections will be risk-based, not biennial.... Read more »
IlluminOss Medical recently received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures.... Read more »
The free app scans and validates HIBCC and GS1 barcodes used for compliance with FDA unique device identification (UDI)... Read more »
ISO 13485:2016 has a greater emphasis on risk management and risk-based decision making.... Read more »
Computational modeling and simulation (CM&S) can revolutionize medical devices by accelerating innovation and providing evidence of long-term safety.... Read more »
The elements are derived from the biological, mechanical or clinical performance requirements of the device and regulatory requirements for performance and safety.... Read more »
While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017. ... Read more »
FDA did not offer device companies new direction on methods to direct mark, as it would be difficult to account for the wide variety of existing devices, use conditions and reprocessing methods.... Read more »
The orthopaedic device company is investing more than $7 million in manufacturing and research.... Read more »
After six years of successful operation and more than 100 graduates of ORCA, it was time to revise the program.... Read more »
Good Manufacturing Practices/QS Regulation and ISO 13485:2016 resemble each other with respect to medical device manufacturing and design quality systems. Despite the similarities, it is the interpretation and the approach of the investigator or the auditor that makes the experience very different.&... Read more »
As part of its strategy to become a global solutions provider to the medical device industry, Elos Medtech acquired U.S. based Onyx Medical in 2015, effectively establishing a presence in the largest orthopaedic market.... Read more »
Increased regulatory scrutiny and payor power continue to affect healthcare globally, leading companies to create cross-department teams and seek collaboration amongst customers within the supply chain in order to remain innovative and competitive.... Read more »
OEMs and suppliers can reduce cost and lead times while preserving or improving margins with numerous initiatives that don't require material or design changes. Simply commit to a cost-focused collaboration that is incorporated into the terms of a master supply or service agreement.... Read more »
Enactment of the EU's Medical Device Regulations is expected to increase challenges for orthopaedic companies seeking CE Mark Approval.... Read more »
The Ovation Awards recognize growth, success and contributions to the Kenosha, Wisconsin area and its economic development.... Read more »
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 »
Do changes to your device warrant a 510(k) submission? There are several elements to consider: design controls compliance, risk analysis and postmarket surveillance data, among them.... Read more »
UDI regulations have altered your business. Gaining solid ROI from your compliance efforts comes down to internal efficiency, capturing your own master data and learning how to use that data for product development, marketing and logistics.... Read more »
FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier.... Read more »
CoorsTek has acquired Philips’ ceramics operations in Uden, The Netherlands.
Through this acquisition, CoorsTek expands its strategic partnership with Philips and will serve both Philips and other regional customers from Uden. Adding Uden extends the CoorsTek footprint to a dozen European ma... Read more »
Lucideon, a materials technology company, and Hong Kong Standards and Testing Centre (STC), a testing, inspection and certification organization based in Hong Kong and China, are offering a series of seminars on wear testing and medical device testing to orthopaedic implant manufacturers and their s... Read more »
FDA released its annual priority list for the new year, as well as previously-issued final guidance documents, on which CDRH is accepting feedback as part of its retrospective review.... Read more »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
Regulatory requirements continue to evolve and become increasingly complex. A solid strategy and execution can maximize opportunity to achieve regulatory goals and provide competitive advantage.... Read more »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
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 »
The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.
Algea TherapiesAffirm Vertebral Compression Fracture System... Read more »
RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality... Read more »
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 »
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 »
InVivoLink Introduces OrthoPod, a Tablet-based Implant Registry Application;
Emergo Group Medical Device Blog for QA/RA Professionals;
IMARC Research Blog... Read more »
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 »
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 »
Co-authored by Keith Kennedy
Perhaps more than at any other time in recent years, we are witnessing rapid changes in the way products and procedures are developed and measured in orthopaedics. In addition to innovative product advancements, there is a groundswell of interest in tracking product and... Read more »
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 »
