FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
313–336 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 09, 2026
Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)
K253189 · MBH
Zimmer, Inc.
Orthopedic · 164d
Cleared Mar 06, 2026
Treace Medical Concepts (TMC) Screw Fixation System
K260361 · HWC
Treace Medical Concepts, Inc.
Orthopedic · 30d
Cleared Mar 06, 2026
TeKBrace Knotless Anchor
K253538 · MBI
Theramicro
Orthopedic · 113d
Cleared Mar 05, 2026
Phantom® Hindfoot TTC/TC Nail System
K253591 · HSB
Paragon 28, Inc.
Orthopedic · 108d
Cleared Mar 05, 2026
Arthrex FibuLock Nail System
K252196 · HSB
Arthrex, Inc.
Orthopedic · 234d
Cleared Mar 04, 2026
ANTERIS Thoracolumbar Plate System
K260015 · KWQ
SpineCraft
Orthopedic · 58d
Cleared Mar 04, 2026
Aevumed FENIX Suture Anchor
K254306 · MBI
Aevumed, Inc.
Orthopedic · 63d
Cleared Mar 04, 2026
Active Intramedullary (AIM) Tibial Nail System
K252025 · HSB
Satori Orthopaedics, Inc.
Orthopedic · 247d
Cleared Mar 03, 2026
Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button
K260353 · HRS
Arthrex, Inc.
Orthopedic · 28d
Cleared Mar 03, 2026
TMINI® Miniature Robotic System
K260010 · OLO
THINK Surgical, Inc.
Orthopedic · 60d
Cleared Mar 03, 2026
PathLoc Lumbar Plate System
K251940 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 252d
Cleared Mar 02, 2026
Arthrex Nano FiberTak Suture Anchor
K254229 · MBI
Arthrex, Inc.
Orthopedic · 63d
Cleared Mar 02, 2026
VOLT™ Ankle Trauma 2.7/3.5 Plating System
K254054 · HRS
Synthes GmbH
Orthopedic · 75d
Cleared Feb 27, 2026
HKT Anatomical Locking Trauma System
K254249 · HRS
Hankil Tech Medical Co., Ltd.
Orthopedic · 60d
Cleared Feb 27, 2026
LigaMend
K253695 · MBI
Riverpoint Medical, LLC
Orthopedic · 98d
Cleared Feb 26, 2026
Aster
K254182 · KWQ
Osteonic Co., Ltd.
Orthopedic · 65d
Cleared Feb 26, 2026
SWINGO-3D Lumbar Cage System
K254017 · MAX
Implanet
Orthopedic · 73d
Cleared Feb 26, 2026
ENOS Software Guided External Fixation System
K253764 · OSN
Disior, Ltd.
Orthopedic · 93d
Cleared Feb 26, 2026
GMK 3D Metal Tibial Tray Extension
K253328 · MBH
Medacta International S.A.
Orthopedic · 149d
Cleared Feb 26, 2026
RIB LINK™ Fixation System
K252166 · HRS
Globus Medical, Inc.
Orthopedic · 231d
Cleared Feb 25, 2026
Mako Total Knee Application
K260222 · OLO
Mako Surgical Corp.
Orthopedic · 30d
Cleared Feb 25, 2026
Ventana™ A Anterior Lumbar Interbody System
K253559 · OVD
Spinal Elements, Inc.
Orthopedic · 100d
Cleared Feb 25, 2026
FIREFLY® Pedicle Screw Navigation Guide
K253472 · PQC
Mighty Oak Medical
Orthopedic · 138d
Cleared Feb 24, 2026
OSTEOMNI SPINAL FIXATION SYSTEM
K254247 · NKB
OSTEOMNI, Inc.
Orthopedic · 57d