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