FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
409–432 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 31, 2025
Tyber Medical Trauma Screw
K252901 · HWC
Tyber Medical, LLC
Orthopedic · 111d
Cleared Dec 30, 2025
Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm
K253895 · MBI
Arthrex, Inc.
Orthopedic · 26d
Cleared Dec 29, 2025
ZipToe™ Hammertoe Fusion System
K253325 · HTY
Toetal Solutions
Orthopedic · 90d
Cleared Dec 23, 2025
OsteoRemedies Hip Spacer System
K253675 · KWL
Osteoremedies, LLC
Orthopedic · 32d
Cleared Dec 23, 2025
Active-V Total Knee System
K253239 · MBH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 85d
Cleared Dec 23, 2025
MiiS Horus Arthroscope (EJA 100)
K253217 · HRX
Medimaging Integrated Solution, Inc...
Orthopedic · 85d
Cleared Dec 22, 2025
HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)
K253876 · OVE
Globus Medical, Inc.
Orthopedic · 18d
Cleared Dec 22, 2025
Syndesmosis TightRope PRO
K253727 · HTN
Arthrex, Inc.
Orthopedic · 28d
Cleared Dec 22, 2025
TMINI Miniature Robotic System
K253661 · OLO
THINK Surgical, Inc.
Orthopedic · 32d
Cleared Dec 22, 2025
aprevo® cervical plating system
K252611 · KWQ
Carlsmed, Inc.
Orthopedic · 126d
Cleared Dec 19, 2025
Monkey Rings External Ring Fixation System
K253613 · KTT
Paragon 28, Inc.
Orthopedic · 31d
Cleared Dec 19, 2025
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
K253577 · MAX
Medicrea International S.A.S....
Orthopedic · 32d
Cleared Dec 19, 2025
Hoffmann LRF System
K253202 · KTT
Stryker GmbH
Orthopedic · 84d
Cleared Dec 19, 2025
Balanced Knee System TriMax Porous Femoral Components
K253161 · MBH
Ortho Development Corp.
Orthopedic · 84d
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