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
433–456 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 10, 2025
TMINI Miniature Robotic System
K252544 · OLO
THINK Surgical, Inc.
Orthopedic · 59d
Cleared Oct 10, 2025
Eleganz IM Threaded Nail System (IM Threaded Nail System)
K252312 · HWC
Dev4
Orthopedic · 78d
Cleared Oct 09, 2025
iFuse Bedrock Granite Implant System
K253094 · OUR
SI-BONE, Inc.
Orthopedic · 16d
Cleared Oct 09, 2025
Pediatric Plating Platform I Small-Mini
K252600 · HRS
OrthoPediatrics Corp.
Orthopedic · 52d
Cleared Oct 08, 2025
MetaFore Small Screw System
K250536 · HWC
Extremity Medical, LLC
Orthopedic · 226d
Cleared Oct 07, 2025
Eminent Spine Posterior SI System
K250894 · OUR
Eminent Spine
Orthopedic · 196d
Cleared Oct 03, 2025
AETOS Shoulder System Stemless Humeral Prosthesis
K252129 · PKC
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Oct 03, 2025
xvision Spine system
K251639 · SBF
Augmedics, Ltd.
Orthopedic · 127d
Cleared Oct 02, 2025
Cannulated Screw and Kirschner (K wire) System
K252758 · HWC
Orthonovis, Inc.
Orthopedic · 34d
Cleared Oct 01, 2025
Newclip Patient-matched instrumentation non sterile PSI
K250767 · PBF
Newclip Technics
Orthopedic · 202d
Cleared Sep 30, 2025
External Fixation Mini Rail System
K252106 · KTT
Paragon 28, Inc.
Orthopedic · 89d
Cleared Sep 30, 2025
Allomatrix (Allomatrix Injectable Putty
K252085 · MQV
Wright Medical Technology, Inc....
Orthopedic · 90d
Cleared Sep 30, 2025
Arthrex SpeedFLEX™ Implant
K251690 · OWY
Arthrex, Inc.
Orthopedic · 120d
Cleared Sep 29, 2025
UltraGuideCTR® image guided soft tissue release system
K252594 · HRX
Sonex Health
Orthopedic · 45d
Cleared Sep 29, 2025
SpineAR SNAP (SyncAR Spine)
K252054 · SBF
Surgical Theater, Inc.
Orthopedic · 90d
Cleared Sep 26, 2025
Inset Reverse Total Shoulder System
K252221 · PHX
Shoulder Innovations, Inc.
Orthopedic · 72d
Cleared Sep 25, 2025
Stem Extension Line (U2 Total Knee System—PSA Type)
K252725 · JWH
United Orthopedic Corporation
Orthopedic · 28d
Cleared Sep 25, 2025
RPS Primary TKA Software
K251971 · OLO
Stryker Instruments
Orthopedic · 91d
Cleared Sep 25, 2025
Auxano® Wedge Fixation System
K251791 · PLF
Auxano Medical, LLC
Orthopedic · 106d
Cleared Sep 25, 2025
Endeavor™ Stand-Alone Cervical IBF System
K250076 · OVE
Innovasis
Orthopedic · 258d
Cleared Sep 19, 2025
Impact PEEK Union Nail System
K252657 · HTY
Nvision Biomedical Technologies, Inc.
Orthopedic · 28d
Cleared Sep 19, 2025
Tapestry Biointegrative Implant
K252647 · OWY
Embody, Inc.
Orthopedic · 29d
Cleared Sep 19, 2025
Coated hip implants
K250450 · LZO
Medacta International S.A.
Orthopedic · 213d
Cleared Sep 18, 2025
Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody...
K251479 · MAX
Mobarn Medical Devices, LLC
Orthopedic · 128d