January 2019 | Volume 2
Companies With First Ortho 510(k)
This list recognizes companies from Alaska, India, Ireland and South Korea whose products serve spine to sports medicine market segments.
FDA's Updated 510(k) Process
FDA announced changes to keep up with new technologies and more sophisticated approaches to healthcare, taking aim at older predicates.
Orchid Acquired by Nordic Capital
Orchid, the second largest orthopaedic device contract manufacturer, grew revenues to more than $315MM, by our estimates, under ownership by Altor.
Harvey Performance Acquires Carbide Cutting Tool Manufacturer Micro 100
Accu-Tube Launches Rebranding Campaign for 45th Anniversary
GE Additive Subsidiary AP&C Expands Metal Powder Production
Fort Wayne Metals to Open New R&D Space
Boothroyd Dewhurst Releases DFMA 2019 Software
Ads due for the March Issue
Distribution at AAOS.
due for Exhibitor
Attendee Registration opens
Orthopaedic Manufacturers Support Real-World Evidence Studies
One test-case will bring together DJO, DePuy Synthes, Smith & Nephew, Stryker, Zimmer Biomet and the
American Joint Replacement Registry.
Kyocera Acquires Renovis Surgical Technologies Assets
The transaction complements U.S. sales of Kyocera's FDA-cleared total hip and brings access to spine products--a new market segment for the company..
Additive Case Study Shows Potential to Double Production of Implants
An additive manufacturing software company decreased implant build time by 40% with its own technology platform and Renishaw's RenAM 500Q powder bed fusion printer.
HoloSurgical's Augmented Reality, AI-Based System Used in Spinal Procedure
ARAI is a surgical navigation system that provides patient-specific 3D anatomical visualization for pre-op planning, intra-op guidance and post-op data analytics.
Featured White Paper:
Advanced Metrology Options for Medical Device Manufacturers
You need not rely on go/no-go gaging methods. With non-contact video and multi-sensor systems, 100% inspection can be realized and speed/throughput can increase.
From the Archives:
How Often Should You Audit Your Suppliers?
There isn't a one-size-fits-all concept for auditing suppliers. You should develop a frequency for audits based on science and knowledge of your product/use risk levels.
Search orthopaedic suppliers by capability, certification and geographic region. Notice the OMTEC badge for those companies exhibiting in June, and begin to set up your meetings!
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