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
1–24 of 17,899
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 31, 2026
Lantern Knee Navigation Unit (406000-03)
K262253 · ONN
Orthalign, Inc.
Orthopedic · 29d
Cleared Jul 31, 2026
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial...
K262251 · JWH
Globus Medical, Inc.
Orthopedic · 30d
Cleared Jul 31, 2026
xvision Spine system
K261854 · SBF
Augmedics, Ltd.
Orthopedic · 58d
Cleared Jul 31, 2026
Vertiwedge® Intraosseous System
K261810 · MQP
Foundation Surgical Group
Orthopedic · 60d
Cleared Jul 31, 2026
Interwedge® Standalone Lateral
K261809 · OVD
Foundation Surgical Group
Orthopedic · 60d
Cleared Jul 31, 2026
ZSAlign Cervical Interbody System
K261451 · OVE
Zsfab, Inc.
Orthopedic · 91d
Cleared Jul 30, 2026
AIR+ All-Inside Meniscal Repair Device, Curved Up
K262369 · MBI
Stryker Endoscopy
Orthopedic · 20d
Cleared Jul 30, 2026
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral...
K261410 · OLO
Suite 201, National Innovation Centre
Orthopedic · 91d
Cleared Jul 30, 2026
Arthrex Radial Head Replacement System
K260624 · KWI
Arthrex, Inc.
Orthopedic · 154d
Cleared Jul 29, 2026
Suture Button Repair System
K261770 · MBI
Skeletal Dynamics, Inc.
Orthopedic · 61d
Cleared Jul 29, 2026
SPINEART Navigation Instrument System
K261205 · OLO
Spineart SA
Orthopedic · 107d
Cleared Jul 28, 2026
Xpert Ankle
K261511 · HRS
Newclip Technics
Orthopedic · 82d
Cleared Jul 28, 2026
TruLift Expandable System
K261430 · MAX
Life Spine, Inc.
Orthopedic · 89d
Cleared Jul 24, 2026
REMEDY POLY+PLUS SNAP FIT Acetabular Cup
K262290 · KWL
Osteoremedies, LLC
Orthopedic · 18d
Cleared Jul 24, 2026
Ion-L Navigated Instruments
K262121 · OLO
SurGenTec, LLC
Orthopedic · 31d
Cleared Jul 24, 2026
TMINI Miniature Robotic System
K261024 · OLO
THINK Surgical, Inc.
Orthopedic · 116d
Cleared Jul 24, 2026
QUATTRO Spinal system (Open Configuration)
K260362 · NKB
MANTIZ Co., Ltd.
Orthopedic · 170d
Cleared Jul 24, 2026
Tiger 2 System
K253943 · NKB
Zavation Medical Products, LLC
Orthopedic · 226d
Cleared Jul 23, 2026
Klassic Infection Spacer System
K261734 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 58d
Cleared Jul 23, 2026
3d Cage Cervical
K253041 · ODP
Fims Co., Ltd.
Orthopedic · 304d
Cleared Jul 22, 2026
E3D™-C Interbody System
K262094 · OVE
Evolution Spine
Orthopedic · 30d
Cleared Jul 22, 2026
Lapidus Screw Kit
K262075 · HWC
Relja Innovations, LLC
Orthopedic · 30d
Cleared Jul 22, 2026
Op.n™ Spine Navigation and Robotic Guidance
K261113 · OLO
Ecential Robotics
Orthopedic · 110d
Cleared Jul 22, 2026
Tornier Perform Advanced Glenoid
K260721 · KWS
Tornier, Inc.
Orthopedic · 139d