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
337–360 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 19, 2025
EMPOWR Knee
K252974 · JWH
Encore Medical, L.P.
Orthopedic · 93d
Cleared Dec 19, 2025
MSFX MIKRON PEEK CAGES
K252781 · ODP
Mikron Makina Sanayi VE Tic. Ltd. Sti.
Orthopedic · 108d
Cleared Dec 19, 2025
Pectus Versa System
K251050 · HRS
Gm Dos Reis Industria E Comercio
Orthopedic · 260d
Cleared Dec 17, 2025
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K253721 · NKB
S.M.A.I.O
Orthopedic · 23d
Cleared Dec 17, 2025
Vital™ Spinal Fixation System
K253093 · NKB
Highridge Medical, LLC
Orthopedic · 85d
Cleared Dec 17, 2025
BRUSIO Trauma Toolbox System
K252191 · HRS
Bonebridge AG
Orthopedic · 156d
Cleared Dec 16, 2025
Companion Spine DIAM™ Instrumentation
K253118 · QLR
Companion Spine France
Orthopedic · 83d
Cleared Dec 16, 2025
Cambridge Partial Knee
K251771 · HSX
Signature Orthopaedics Pty, Ltd.
Orthopedic · 189d
Cleared Dec 15, 2025
Paradigm System
K252950 · OLO
Proprio, Inc.
Orthopedic · 90d
Cleared Dec 15, 2025
Triathlon® Tritanium® Asymmetric Patella
K252898 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 95d
Cleared Dec 15, 2025
OptiMesh Multiplanar Expandable Interbody Fusion System
K251302 · OQB
Spineology, Inc.
Orthopedic · 231d
Cleared Dec 12, 2025
Affixus® Natural Nail® Proximal Humeral System
K253749 · HSB
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 17d
Cleared Dec 11, 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · OVE
4Web Medical, Inc.
Orthopedic · 76d
Cleared Dec 11, 2025
HyperFlex® Bunion Correction System
K252997 · HRS
Hyperflex Medical
Orthopedic · 84d
Cleared Dec 11, 2025
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw)
K252897 · HRS
A Plus Biotechnology Co., Ltd.
Orthopedic · 91d
Cleared Dec 11, 2025
KLS Martin Pure Pectus System
K250988 · HRS
KLS-Martin L.P.
Orthopedic · 255d
Cleared Dec 10, 2025
ARIX Femur Nail System
K252826 · HSB
Jeil Medical Corporation
Orthopedic · 96d
Cleared Dec 08, 2025
DeGen Medical Patient Specific Implant (PSI) System
K251829 · OVD
Degen Medical
Orthopedic · 178d
Cleared Dec 05, 2025
REAL INTELLIGENCE™ CORI™ XT (CORI XT)
K252841 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 88d
Cleared Dec 05, 2025
Velora Acetabular System
K252067 · LPH
Restor3D, Inc.
Orthopedic · 157d
Cleared Dec 05, 2025
PUREVUE™ FMS
K250795 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 266d
Cleared Dec 05, 2025
SpineLinc Anterior Cervical Implant System
K250764 · ODP
Lincotek Medical
Orthopedic · 267d
Cleared Dec 05, 2025
VSP Orthopedics System
K250711 · PBF
3D Systems, Inc.
Orthopedic · 270d
Cleared Dec 04, 2025
Tigon Medical Knotless and Dual Javelin All-Suture Anchors
K252596 · MBI
Tigon Medical
Orthopedic · 111d