FDA 510(k) clearances and recalls: Orthopedic devices
53 FDA 510(k) clearances and recalls: Orthopedic devices are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Tdm Co., Ltd. with 3. Data last updated 2026-11-03; each record links to its official source and a full report.
Data as of · Compiled by Zalwin from U.S. FDA openFDA
Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe
53 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Tdm Co., Ltd. (3). Each record links to a full report and the official source.
Last updated 2026-11-03. Source: U.S. FDA openFDA.
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- Tdm Co., Ltd. (3)
- GS Medical Co., Ltd. (2)
- Nvision Biomedical Technologies (2)
- Nexus CMF, LLC (1)
- Rivarp Medical Pvt., Ltd. (1)
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What are the top FDA 510(k) clearances and recalls: Orthopedic devices right now?
Browse 35 more matching record reports
- Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH
- GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V.
- Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc.
- M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A.
- Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd.
- Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd.
- Vantage Lumbar Decompression Kit (K263208): 510(k) cleared for SurGenTec, LLC
- prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC
- AltiVate Reverse® Glenosphere with RAVN Technology (K263086): 510(k) cleared for Encore Medical L.P.
- ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc.
- OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies
- TDM Large Bone Plate and Screw System (K261611): 510(k) cleared for Tdm Co., Ltd.
- Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC
- NEXUS® Hip Stem (K262473): 510(k) cleared for Microport Orthopedics, Inc.
- NOVIX Pedicle Screw System (K263062): 510(k) cleared for Tdm Co., Ltd.
- SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc.
- Arthrex Beaming System (K262975): 510(k) cleared for Arthrex, Inc.
- OsseoFit Stemless Shoulder System (K262955): 510(k) cleared for Zimmer, Inc.
- SABER-C System (K263049): 510(k) cleared for Elevation Spine
- Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd.
- Ntegrate Threaded Nail System (K261961): 510(k) cleared for Nvision Biomedical Technologies
- Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System (K261607): 510(k) cleared for Spinal Simplici
- Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC
- NeckTune SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd.
- Spinalogic Bone Growth Stimulator (K262721): 510(k) cleared for Djo, LLC
- Alians Forearm (K262649): 510(k) cleared for Newclip Technics
- corra® cervical plating system (K262149): 510(k) cleared for Carlsmed, Inc.
- ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc.
- G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet
- iFuse Granite Onyx Implant System (K262067): 510(k) cleared for SI-BONE, Inc.
- EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies
- TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc.
- Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc.
- FRAXION Spinal Fixation System (K262091): 510(k) cleared for Ortler Global Tibbi Gerecler Anonim Sirketi
- GMK Extension (K262057): 510(k) cleared for Medacta International SA
Which related categories and locations should I check?
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510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)
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Radiology (56) Cardiovascular (52) General & Plastic Surgery (44) Dental (32) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)
Browse by record type by specialty
Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)
Frequently asked questions
How many FDA 510(k) clearances and recalls: Orthopedic devices are listed?
53 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.
Can I get alerts for Orthopedic?
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