FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,899 results
481–504 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 25, 2025
Maxx Libertas Bipolar Hip Head (Bipolar Hip)
K243634 · KWY
Maxx Orthopedics, Inc.
Orthopedic · 273d
Cleared Aug 22, 2025
Stem Extension Line (USTAR II System)
K252303 · KRO
United Orthopedic Corporation
Orthopedic · 29d
Cleared Aug 21, 2025
The Acumed Wrist Fixation System - 2.4mm Screws
K252356 · HRS
Acumed, LLC
Orthopedic · 23d
Cleared Aug 21, 2025
Treace Medical Concepts (TMC) Implant Fixation System
K251135 · HRS
Treace Medical Concepts
Orthopedic · 129d
Cleared Aug 21, 2025
Fine Osteotomy™
K250923 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 147d
Cleared Aug 20, 2025
Distal Xtremities System
K252061 · HRS
TriMed, Inc.
Orthopedic · 50d
Cleared Aug 20, 2025
T2 Alpha Humerus Nailing System
K251400 · HSB
Stryker GmbH
Orthopedic · 106d
Cleared Aug 19, 2025
OSSIOfiber® Interference Screw
K252022 · MAI
OSSIO , Ltd.
Orthopedic · 50d
Cleared Aug 18, 2025
ANTHEM® Fracture System
K251161 · HRS
Globus Medical, Inc.
Orthopedic · 125d
Cleared Aug 18, 2025
Evolution Spine Navigation Instruments
K250167 · OLO
Evolution Spine
Orthopedic · 209d
Cleared Aug 16, 2025
OsteoCentric® UnifiMI® TCS Plating System
K251913 · HRS
OsteoCentric Technologies
Orthopedic · 54d
Cleared Aug 15, 2025
Atlas Spine Project X Expandable Posterior Lumbar Interbody System
K251969 · MAX
Atlas Spine, Inc.
Orthopedic · 50d
Cleared Aug 15, 2025
Persona Partial Knee
K251834 · HSX
Zimmer Biomet
Orthopedic · 60d
Cleared Aug 15, 2025
Dunamis Screw and Suture Locking System
K250867 · HWC
Dunamis Medical, LLC
Orthopedic · 144d
Cleared Aug 15, 2025
KLS Martin Ixos System
K250620 · HRS
KLS-Martin L.P.
Orthopedic · 168d
Cleared Aug 14, 2025
Stitch Cerclage – Suture Tapes
K243905 · JDQ
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 238d
Cleared Aug 13, 2025
T2 Alpha Femur Retrograde Nailing System
K250163 · HSB
Stryker GmbH
Orthopedic · 204d
Cleared Aug 11, 2025
External Fixation Bone Distractor
K251862 · KTT
Paragon 28, Inc.
Orthopedic · 55d
Cleared Aug 11, 2025
Identity Revision Humeral Stems
K251098 · MBF
Zimmer, Inc.
Orthopedic · 123d
Cleared Aug 08, 2025
OptiVu™ Shoulder
K252170 · SBF
Mr Surgical Solutions, LLC
Orthopedic · 29d
Cleared Aug 08, 2025
SABER-C System
K250540 · OVE
Elevation Spine
Orthopedic · 165d
Cleared Aug 08, 2025
SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
K250472 · KTT
Amdt Holdings, Inc.
Orthopedic · 171d
Cleared Aug 07, 2025
Succession™ AFN System
K250622 · HSB
Ortho Solutions UK , Ltd.
Orthopedic · 160d
Cleared Aug 07, 2025
Longboard Revision Hip Stem
K243021 · LZO
Signature Orthopaedics Pty, Ltd.
Orthopedic · 314d