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
505–528 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 06, 2025
InterSpace GV Hip Spacer
K252326 · KWL
Tecres S.P.A.
Orthopedic · 12d
Cleared Aug 06, 2025
Aevumed PHANTOM Suture Anchors
K242895 · MBI
Aevumed, Inc.
Orthopedic · 317d
Cleared Aug 05, 2025
AltiVate Reverse® Glenoid
K252141 · PHX
Encore Medical, L.P.
Orthopedic · 28d
Cleared Aug 05, 2025
PRADO™ Lumbar Interbody Fusion System
K252113 · MAX
Bethesda Medical Devices
Orthopedic · 29d
Cleared Aug 01, 2025
RONAVIS – FX (FX-001)
K250315 · HTY
AIRS, Inc.
Orthopedic · 178d
Cleared Aug 01, 2025
Equinoxe® Shoulder System
K243448 · PHX
Exactech, Inc.
Orthopedic · 267d
Cleared Jul 31, 2025
NextAR(TM) Spine
K250477 · SBF
Medacta International S.A.
Orthopedic · 162d
Cleared Jul 31, 2025
U2 Total Knee System – PF+ Patella
K243656 · MBH
United Orthopedic Corporation
Orthopedic · 247d
Cleared Jul 31, 2025
Trabecular Metal Acetabular Revision System, Acetabular Liners and...
K243571 · JDI
Zimmer Biomet
Orthopedic · 255d
Cleared Jul 31, 2025
Mpact Constrained Liner
K241461 · KWZ
Medacta International S.A.
Orthopedic · 434d
Cleared Jul 30, 2025
Iconix Speed Anchor
K252144 · MBI
Riverpoint Medical
Orthopedic · 22d
Cleared Jul 30, 2025
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · OVE
Acuity Surgical Devices, LLC
Orthopedic · 54d
Cleared Jul 30, 2025
Tyber Medical Distal Radius Plating System
K251361 · HRS
Tyber Medical, LLC
Orthopedic · 90d
Cleared Jul 30, 2025
CORUS™ Navigation System-GX
K251060 · OLO
Providence Medical Technology, Inc.
Orthopedic · 117d
Cleared Jul 30, 2025
SpineSite Endoscope System
K241990 · HRX
Hydrocision, Inc.
Orthopedic · 387d
Cleared Jul 29, 2025
SImmetry+ System
K250647 · OUR
Sivantage
Orthopedic · 147d
Cleared Jul 29, 2025
Forcyte Autograft Harvest Kit
K243407 · KNW
Forcyte Medical, LLC
Orthopedic · 270d
Cleared Jul 25, 2025
Triathlon® Hinge Knee System
K251665 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Jul 25, 2025
A.L.P.S. Proximal Humerus Plating System
K251620 · HRS
Zimmer Biomet
Orthopedic · 59d
Cleared Jul 25, 2025
Stryker and Serf hip devices
K250989 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 116d
Cleared Jul 24, 2025
MOTO Partial Knee System Extension
K251618 · HSX
Medacta International S.A.
Orthopedic · 58d
Cleared Jul 23, 2025
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the...
K251073 · OLO
Innovasis, Inc.
Orthopedic · 106d
Cleared Jul 22, 2025
OTS 25-L (100-5)
K251310 · MBI
Ots Medical , Ltd.
Orthopedic · 85d
Cleared Jul 18, 2025
Z1 Hip System
K251906 · LZO
Zimmer, Inc.
Orthopedic · 28d