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
217–240 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 12, 2026
VantageTM Lumbar Decompression Kit
K252546 · HRX
Allevion Medical, LLC
Orthopedic · 212d
Cleared Mar 12, 2026
implaFit® short stems
K252401 · LZO
Implantcast GmbH
Orthopedic · 224d
Cleared Mar 12, 2026
Trax EX Anchor
K251750 · MBI
Trax Surgical, Inc.
Orthopedic · 276d
Cleared Mar 11, 2026
Xpert Hand
K253906 · HRS
Newclip Technics
Orthopedic · 96d
Cleared Mar 11, 2026
Strut Suture
K253693 · MBI
Riverpoint Medical, LLC
Orthopedic · 110d
Cleared Mar 11, 2026
INHANCE™ Reverse Shoulder System
K253624 · PHX
Depuy Ireland UC
Orthopedic · 113d
Cleared Mar 10, 2026
DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System
K254093
Synthes GmbH
Orthopedic · 81d
Cleared Mar 10, 2026
Reselute Tibial Nail
K253517 · HSB
Reselute, Inc.
Orthopedic · 118d
Cleared Mar 09, 2026
FiberTape Button
K260405 · MBI
Arthrex, Inc.
Orthopedic · 28d
Cleared Mar 09, 2026
DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System
K260069 · HRS
Synthes GmbH
Orthopedic · 59d
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