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
169–192 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 13, 2026
HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK...
K260340 · ODP
HC Biologics, LLC
Orthopedic · 70d
Cleared Apr 13, 2026
InSet Reverse Total Shoulder System
K254128 · PHX
Shoulder Innovations, Inc.
Orthopedic · 112d
Cleared Apr 13, 2026
Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings,...
K253592 · MBF
Zimmer, Inc.
Orthopedic · 147d
Cleared Apr 13, 2026
b-ONE® Bipolar Head
K253357 · KWY
B-One Ortho, Corp.
Orthopedic · 195d
Cleared Apr 10, 2026
SMART Osteotomy System
K260090 · HRS
Actis Medical Pty., Ltd.
Orthopedic · 88d
Cleared Apr 10, 2026
CoAptix S System
K252699 · HWC
University of Utah, Department of...
Orthopedic · 226d
Cleared Apr 09, 2026
Artelon Convenience Kits
K260317 · QWJ
International Life Sciences
Orthopedic · 69d
Cleared Apr 09, 2026
SPINEART Navigation Instrument System
K254158 · OLO
Spineart SA
Orthopedic · 108d
Cleared Apr 08, 2026
CATAMARAN™ SI Joint Fusion System
K260477 · OUR
Tenon Medical
Orthopedic · 55d
Cleared Apr 06, 2026
AETOS Shoulder System - CONCELOC Glenoids
K254084 · KWS
Smith & Nephew, Inc.
Orthopedic · 109d
Cleared Apr 03, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K260786 · NKB
S.M.A.I.O
Orthopedic · 24d
Cleared Apr 03, 2026
Blueprint Patient-Specific Instrumentation
K253674 · PHX
Stryker Corporation (Tornier, S.A.S.)
Orthopedic · 133d
Cleared Apr 03, 2026
Tyber Medical Trauma Screw
K253042 · HWC
Tyber Medical, LLC
Orthopedic · 193d
Cleared Apr 02, 2026
Tahoe Unicondylar Knee System with TiNbN Overcoat
K260796 · HSX
Shalby Advanced Technologies, Inc....
Orthopedic · 22d
Cleared Apr 01, 2026
enHAnce PEEK Bunion System
K253718 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 128d
Cleared Apr 01, 2026
MOD-C
K242303 · ODP
Orthomod, LLC
Orthopedic · 604d
Cleared Mar 27, 2026
VyPlate™ Anterior Cervical Plate System
K260697 · KWQ
Vy Spine, LLC
Orthopedic · 23d
Cleared Mar 27, 2026
SF Push-in Anchor
K260294 · MAI
Surgical Fusion Technologies GmbH
Orthopedic · 57d
Cleared Mar 27, 2026
SYMPHONY Navigation Ready Instruments
K260240 · OLO
Medos International SARL
Orthopedic · 60d
Cleared Mar 27, 2026
Synergy Disc Instruments
K253392 · QLQ
Synergy Spine Solutions, Inc.
Orthopedic · 178d
Cleared Mar 27, 2026
SportLinc Syndesmosis Device
K252081 · HTN
Lincotek Medical
Orthopedic · 268d
Cleared Mar 27, 2026
MedCAD® AccuStride™ System
K252064 · PBF
Medcad
Orthopedic · 269d
Cleared Mar 26, 2026
REAL INTELLIGENCE™ CORI™
K260601 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 30d
Cleared Mar 25, 2026
Vortex5 Tailor's Bunion Correction System
K260291 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 55d