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
97–120 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 29, 2026
Navigated LLIF Impactable Tracker
K261060 · OLO
Tyber Medical, LLC
Orthopedic · 59d
Cleared May 29, 2026
Xpert PFP
K261038 · HRS
Newclip Technics
Orthopedic · 60d
Cleared May 28, 2026
Arthrex Bioabsorbable PushLock Suture Anchors
K253931 · MAI
Arthrex, Inc.
Orthopedic · 170d
Cleared May 28, 2026
BMD Titanium Spinal Fusion System
K253894 · MAX
Global Biomedica s.r.o.
Orthopedic · 175d
Cleared May 28, 2026
Zimmer® Persona® Personalized Knee System
K251840 · MBH
Zimmer, Inc.
Orthopedic · 346d
Cleared May 27, 2026
LigaPASS™ System
K261374 · OWI
Medicrea International S.A.S
Orthopedic · 30d
Cleared May 27, 2026
Dione PEEK Screw System
K253130 · MBI
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 244d
Cleared May 27, 2026
AQUA Laminoplasty Systems
K252930 · NQW
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 254d
Cleared May 26, 2026
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
K254157 · OLO
Medos International SARL
Orthopedic · 155d
Cleared May 26, 2026
JAZBI™ Resorbable Bone Void Filler
K252797 · MQV
Sdip Innovations Pty, Ltd.
Orthopedic · 265d
Cleared May 26, 2026
Digital ClarusScope System and Digital NeuroPEN System
K252790 · HRX
Clarus Medical, LLC
Orthopedic · 266d
Cleared May 22, 2026
Ion-C Navigation Instruments
K260329 · OLO
SurGenTec, LLC
Orthopedic · 112d
Cleared May 22, 2026
DePuy ATTUNE™ Knee System
K252887 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 254d
Cleared May 21, 2026
ROSA® Shoulder System
K260582 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 90d
Cleared May 19, 2026
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
K260146 · HSB
Orthofix Srl
Orthopedic · 119d
Cleared May 19, 2026
Taperloc® Complete Hip Stem
K251270 · LPH
Biomet, Inc.
Orthopedic · 390d
Cleared May 16, 2026
BluEX Cervical Expandable Cage System
K260840 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 61d
Cleared May 15, 2026
Varion Thoracolumbar Fixation System
K260989 · NKB
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic · 51d
Cleared May 15, 2026
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
K260536 · KWL
Depuy Ireland UC
Orthopedic · 87d
Cleared May 15, 2026
Ventana® P/T Lumbar Interbody System
K260506 · MAX
Spinal Elements, Inc.
Orthopedic · 87d
Cleared May 14, 2026
TriMed Compression Screws
K261241 · HWC
TriMed, Inc.
Orthopedic · 29d
Cleared May 14, 2026
CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)
K253676 · MRW
Providence Medical Technology, Inc.
Orthopedic · 174d
Cleared May 14, 2026
ARIES Anterior Cervical Plate Systems
K252776 · KWQ
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 254d
Cleared May 13, 2026
Y-Knotless™ Flex Anchors
K261363 · MBI
Conmed Corporation
Orthopedic · 16d