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
553–576 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 03, 2025
SMR Reverse HP Shoulder System
K243826 · PHX
Lima Corporate S.P.A.
Orthopedic · 203d
Cleared Jul 02, 2025
OsteoFlo HydroFiber
K251720 · MQV
SurGenTec, LLC
Orthopedic · 28d
Cleared Jul 02, 2025
EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)
K251241 · JWH
Encore Medical, L.P.
Orthopedic · 71d
Cleared Jul 02, 2025
Identity Shoulder System
K250848 · MBF
Zimmer, Inc.
Orthopedic · 104d
Cleared Jul 01, 2025
SnugFit ASA Extension
K251933 · MBI
Medacta International S.A.
Orthopedic · 7d
Cleared Jul 01, 2025
Momentum® Posterior Spinal Fixation System
K251719 · NKB
Ulrich Medical USA, Inc.
Orthopedic · 27d
Cleared Jul 01, 2025
Arthrex iBalance Partial Knee System
K251453 · HSX
Arthrex, Inc.
Orthopedic · 50d
Cleared Jun 30, 2025
aprevo® posterior/transforaminal lumbar interbody fusion device
K250987 · MAX
Carlsmed, Inc.
Orthopedic · 91d
Cleared Jun 27, 2025
FIX-C PEEK ACIF SA System
K251431 · OVE
Jeil Medical Corporation
Orthopedic · 50d
Cleared Jun 27, 2025
Testa TP Pivoting Spacer System
K243816 · MAX
Spine Wave, Inc.
Orthopedic · 197d
Cleared Jun 27, 2025
Genostis Osteosynthesis System
K242988 · HRS
Genostis AF
Orthopedic · 274d
Cleared Jun 26, 2025
Freedom® Total Knee System – Titanium Tibial Base Plate
K251717 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 22d
Cleared Jun 26, 2025
The Rialto™ SI Fusion System
K251395 · OUR
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d
Cleared Jun 26, 2025
TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate)
K250929 · HRS
TriMed, Inc.
Orthopedic · 90d
Cleared Jun 26, 2025
Equinoxe® Scapula Fracture System
K243275 · HRS
Exactech, Inc.
Orthopedic · 253d
Cleared Jun 25, 2025
ANAX™ OCT Spinal System
K251725 · NKG
Cg Medtech Co., Ltd.
Orthopedic · 20d
Cleared Jun 25, 2025
BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue)
K251627 · MBI
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jun 25, 2025
X-PAC® LLIF Expandable Lateral Cage System
K251003 · MAX
Expanding Innovations, Inc.
Orthopedic · 85d
Cleared Jun 25, 2025
CORIOGRAPH Pre-Op Planning and Modeling Services
K250921 · PBF
Blue Belt Technologies, Inc.
Orthopedic · 90d
Cleared Jun 24, 2025
GPS Advanced
K251648 · FMF
Prosidyan, Inc.
Orthopedic · 26d
Cleared Jun 24, 2025
ProAM ALIF System
K251644 · OVD
Pro Surgical, Inc.
Orthopedic · 26d
Cleared Jun 24, 2025
PediFlex™ Flexible Nail System
K251362 · HTY
OrthoPediatrics Corp.
Orthopedic · 54d
Cleared Jun 20, 2025
TMINI Miniature Robotic System
K250877 · OLO
THINK Surgical, Inc.
Orthopedic · 88d
Cleared Jun 20, 2025
Incompass Total Ankle System
K250037 · HSN
Wright Medical Technology, Inc....
Orthopedic · 163d