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
241–264 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 27, 2026
LigaMend
K253695 · MBI
Riverpoint Medical, LLC
Orthopedic · 98d
Cleared Feb 26, 2026
Aster
K254182 · KWQ
Osteonic Co., Ltd.
Orthopedic · 65d
Cleared Feb 26, 2026
SWINGO-3D Lumbar Cage System
K254017 · MAX
Implanet
Orthopedic · 73d
Cleared Feb 26, 2026
ENOS Software Guided External Fixation System
K253764 · OSN
Disior, Ltd.
Orthopedic · 93d
Cleared Feb 26, 2026
GMK 3D Metal Tibial Tray Extension
K253328 · MBH
Medacta International S.A.
Orthopedic · 149d
Cleared Feb 26, 2026
RIB LINK™ Fixation System
K252166 · HRS
Globus Medical, Inc.
Orthopedic · 231d
Cleared Feb 25, 2026
Mako Total Knee Application
K260222 · OLO
Mako Surgical Corp.
Orthopedic · 30d
Cleared Feb 25, 2026
Ventana™ A Anterior Lumbar Interbody System
K253559 · OVD
Spinal Elements, Inc.
Orthopedic · 100d
Cleared Feb 25, 2026
FIREFLY® Pedicle Screw Navigation Guide
K253472 · PQC
Mighty Oak Medical
Orthopedic · 138d
Cleared Feb 24, 2026
OSTEOMNI SPINAL FIXATION SYSTEM
K254247 · NKB
OSTEOMNI, Inc.
Orthopedic · 57d
Cleared Feb 24, 2026
OSSIOfiber® Suture Anchor
K254055 · MAI
OSSIO , Ltd.
Orthopedic · 69d
Cleared Feb 23, 2026
LUX Expandable Lumbar Interbody System
K253583 · MAX
Xenix Medical
Orthopedic · 98d
Cleared Feb 23, 2026
Duet™ Spinal Fixation System
K253169 · NKB
Box Spine, LLC
Orthopedic · 150d
Cleared Feb 20, 2026
KLS Martin Ixos System
K254162 · HRS
KLS-Martin L.P.
Orthopedic · 60d
Cleared Feb 20, 2026
KLS Martin Pure Pectus System
K253660 · HRS
KLS-Martin L.P.
Orthopedic · 92d
Cleared Feb 20, 2026
“POINT” Kinguide Agile Hybrid Navigation System
K252989 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 155d
Cleared Feb 19, 2026
Meniscus Versaflex
K254188 · GAT
GM Dos Reis Industria e Comercio Ltda.
Orthopedic · 58d
Cleared Feb 19, 2026
VERTICALE GPS Instruments
K254148 · OLO
Silony Medical GmbH
Orthopedic · 59d
Cleared Feb 19, 2026
Spine Guidance 5.4 Software
K253623 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 93d
Cleared Feb 19, 2026
ATLAS™ Expandable Osteotomy Wedge System
K252733 · PLF
MiRus, LLC
Orthopedic · 175d
Cleared Feb 19, 2026
Valence Robotic Navigation System
K252597 · OLO
Alphatec Spine, Inc.
Orthopedic · 188d
Cleared Feb 18, 2026
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial...
K253637 · MBH
Howmedica Osteonics Corp., Dba...
Orthopedic · 91d
Cleared Feb 17, 2026
Adaptos®Fuse Bone Graft
K253524 · MQV
Biomendex OY
Orthopedic · 96d
Cleared Feb 17, 2026
Biosteon® Screw
K251680 · MAI
Biocomposites, Ltd.
Orthopedic · 263d