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
289–312 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 23, 2026
POINT Kinguide Agile Robotic Arm Surgical Stereotactic System
K252755 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 147d
Cleared Jan 22, 2026
OLYMPIC Posterior Spinal Fixation System
K252885 · PML
Astura Medical
Orthopedic · 134d
Cleared Jan 22, 2026
SMR Shoulder System
K252352 · PHX
Lima Corporate S.P.A.
Orthopedic · 177d
Cleared Jan 21, 2026
Infinity™ OCT System
K254165 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jan 21, 2026
Arthrex Variable Angle (VA) Proximal Tibia Plating System
K253713 · HRS
Arthrex, Inc.
Orthopedic · 58d
Cleared Jan 20, 2026
Excelsior System
K253291 · KTT
Blue Ocean Global
Orthopedic · 113d
Cleared Jan 16, 2026
Curiteva Porous PEEK Cervical Interbody System
K252205 · ODP
Curiteva, Inc.
Orthopedic · 186d
Cleared Jan 16, 2026
MY01 Continuous Compartmental Pressure Monitor
K251900 · LXC
MY01, Inc.
Orthopedic · 210d
Cleared Jan 16, 2026
Ion-C
K251714 · MRW
SurGenTec, LLC
Orthopedic · 227d
Cleared Jan 15, 2026
Curiteva Porous PEEK Cervical Interbody Fusion System
K254061 · ODP
Curiteva, Inc.
Orthopedic · 29d
Cleared Jan 15, 2026
TriMed Volar Bearing Plates (VBEAL-13-7S)
K254002 · HRS
TriMed, Inc.
Orthopedic · 31d
Cleared Jan 15, 2026
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
K253171 · LZO
Maxx Orthopedics, Inc.
Orthopedic · 111d
Cleared Jan 15, 2026
AltiVate Reverse® ADLC Glenosphere
K252567 · PHX
Encore Medical, L.P.
Orthopedic · 154d
Cleared Jan 15, 2026
N22 EZ Glenosphere
K252516 · PHX
Shoulder Innovations, Inc.
Orthopedic · 157d
Cleared Jan 15, 2026
SDS Growing Rod
K251961 · PGM
BAAT Medical Products B.V.
Orthopedic · 203d
Cleared Jan 14, 2026
Cervical Interbody and VBR Fusion System
K252219 · ODP
Sync Surgical
Orthopedic · 183d
Cleared Jan 13, 2026
Swedge™ Pedicle Screw Fixation System Bezier Rod
K252461 · NKB
Spinal Resources, Inc.
Orthopedic · 161d
Cleared Jan 13, 2026
BEAR® (Bridge-Enhanced ACL Restoration) Implant
K251214 · QNI
Miach Orthopaedics, Inc.
Orthopedic · 270d
Cleared Jan 12, 2026
DYNAMIS™ Navigation System
K252962 · OLO
Promethean Restorative, LLC
Orthopedic · 118d
Cleared Jan 12, 2026
Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates
K252807 · HRS
Arthrex, Inc.
Orthopedic · 131d
Cleared Jan 12, 2026
Precision AI Surgical Planning System (PAI-SPS)
K251558 · QHE
Precision AI Pty, Ltd.
Orthopedic · 236d
Cleared Jan 09, 2026
JARVIS Metaphyseal Stem
K254003 · PHX
FH Industrie
Orthopedic · 25d
Cleared Jan 09, 2026
NextAR Hip Platform
K252847 · SBF
Medacta International S.A.
Orthopedic · 123d
Cleared Jan 08, 2026
Titanium Interbody System
K253266 · MAX
Spine Innovation, LLC
Orthopedic · 101d