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
25–48 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 23, 2026
G7® Acetabular System
K261453 · LPH
Zimmer Biomet
Orthopedic · 145d
Cleared Sep 23, 2026
DynaNail Helix® Fixation System
K260995 · HWC
MedShape, Inc.
Orthopedic · 181d
Cleared Sep 21, 2026
F.A.S.T Screw
K254280 · HWC
Steps Ortho
Orthopedic · 265d
Cleared Sep 18, 2026
EnHAnce PEEK Bunion System
K262098 · HRS
Nvision Biomedical Technologies
Orthopedic · 88d
Cleared Sep 17, 2026
FRAXION Spinal Fixation System
K262091 · NKB
Ortler Global Tibbi Gerecler Anonim...
Orthopedic · 87d
Cleared Sep 17, 2026
Integrity Retractable Implant Inserter (6000127)
K261869 · MBI
Anika Therapeutics, Inc.
Orthopedic · 105d
Cleared Sep 17, 2026
Unity Total Knee System, Unity Knee Cementless CR Femur
K261275 · MBH
Corin, Ltd.
Orthopedic · 153d
Cleared Sep 17, 2026
M-Vizion Femoral Revision System Extension
K260173 · LZO
Medacta International S.A.
Orthopedic · 239d
Cleared Sep 17, 2026
The VEGA Cervical Screw System
K254260 · NKG
GS Medical Co., Ltd.
Orthopedic · 262d
Cleared Sep 15, 2026
TMC Implant Fixation System
K262963 · HRS
Treace Medical Concepts, Inc.
Orthopedic · 21d
Cleared Sep 15, 2026
GMK Extension
K262057 · JWH
Medacta International, SA
Orthopedic · 89d
Cleared Sep 14, 2026
RIVA® Posterior Fixation System with NanoACTIV Surface Technology
K262193 · NKB
Xenix Medical
Orthopedic · 77d
Cleared Sep 11, 2026
Mg OSTEOREVIVE™
K262230 · MQV
Bone Solutions, Inc.
Orthopedic · 73d
Cleared Sep 11, 2026
Innovasis AxTiHA® Stand-Alone ALIF System
K262025 · OVD
INNO Holdings Inc. DBA Innovasis
Orthopedic · 87d
Cleared Sep 11, 2026
DRIM-Nail System
K260115
41Medical AG
Orthopedic · 240d
Cleared Sep 11, 2026
GSPE Spacer
K260063 · JWH
The General Hospital Corporation,...
Orthopedic · 246d
Cleared Sep 10, 2026
EVOLUTION MPX™ Total Knee System
K262293 · JWH
Suzhou Microport Orthorecon Co., Ltd.
Orthopedic · 65d
Cleared Sep 08, 2026
b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem...
K262341 · JWH
B-One Ortho, Corp.
Orthopedic · 60d
Cleared Sep 08, 2026
N22 Offset Humeral Head
K262173 · KWT
Shoulder Innovations, Inc.
Orthopedic · 74d
Cleared Sep 08, 2026
LANDMARK Total Knee System
K261462 · MBH
Smith & Nephew, Inc.
Orthopedic · 127d
Cleared Sep 04, 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD
K262828 · NKB
S.M.A.I.O
Orthopedic · 25d
Cleared Sep 04, 2026
ATTUNE Revision Knee System
K262130 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 72d
Cleared Sep 04, 2026
ActivaScrew™ Cannulated COM
K261057 · HWC
Bioretec, Ltd.
Orthopedic · 157d
Cleared Sep 03, 2026
Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)
K262769 · MTJ
Orthocon, Inc.
Orthopedic · 30d