Strategic Orthopaedic-related 510(k) Update

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. An asterisk denotes those receiving their first clearance for an orthopaedic product.

DeGen Medical
F-Modular Pedicle Screw, K142531*
     •   Titanium/Titanium Alloy or Cobalt-Chrome Alloy
     •   Rods, screws, screw bodies, head assemblies, set screws and a pre-assembled poly-axial screw; to provide
          immobilization of the thoracic, lumbar and sacral spine 
     •   Also intended for posterior, non-cervical fixation in pediatric patients as an adjunct to fusion to treat adolescent idiopathic
         scoliosis, with autograft and/or allograft

Eminent Spine
Foot Plate System, K143365
     •    Includes 24 types of titanium plates
     •    For fixation of fractures, osteotomies, non-unions, revisions, replantations of bones and bone fragments including
          tarsals, metatarsals, calcaneus, foot and ankle
     •    First clearance for a non-spinal product

 

Miami Device Solutions
Proximal Humerus Plate, K141493*
Supplier, specializing in design, manufacture and testing of high precision
metallic parts with a main focus on medical devices

Osteotec 
Silicone Finger Implant, K140453* 
     •    High tear-resistant implant grade silicone, 11 evenly scaled sizes 
     •    U.K. company with own branded implants and exclusive U.K. distribution
          for products from Arex, FzioMed, Integra, Normed, Osteomed and
          Trimed 

Treace Medical Concepts 
TMC Plating System, K143717* 
     •    Titanium straight, L-shaped and H- shaped plates and screws 
     •    For stabilization/fixation of fractures, revision procedures, fusions and
           reconstructions of small bones of the foot 
     •    Company established in 2014, focused on U.S. foot/ankle 
     •    Principals have a variety of experience at companies including Concept 
          (now ConMed Linvatec), DePuy, IMDS, Medtronic, Richards, Smith
          & Nephew, Spinal Dynamics, TreBay, Wright Medical

                


                                                    

More FDA news: 



CDRH Proposes
Nationwide Postmarket
Surveillance System

CAPA+2, UDI and More:
What to Expect
from FDA in 2015

FDA Publishes
Priorities for 2015

 

 

Sources: FDA 510(k) Releasable Database, 3/16/15-4/21/15, company web sites