- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - Orthopedic devices: recent FDA 510(k) clearances # Orthopedic devices: recent FDA 510(k) clearances **53 orthopedic devices: recent FDA 510(k) clearances 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 2026-11-04; each record links to its official source and a full report.** Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 53 orthopedic devices: recent FDA 510(k) clearances (CSV) — $4.99 → Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=Orthopedic&record_type=clearance) 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 2026-11-04. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?panel=Orthopedic&record_type=clearance&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?panel=Orthopedic&record_type=clearance) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 53 Most frequent - Tdm Co., Ltd. (3) - GS Medical Co., Ltd. (2) - Nvision Biomedical Technologies (2) - Nexus CMF, LLC (1) - Rivarp Medical Pvt., Ltd. (1) ## How do I get new orthopedic devices: recent FDA 510(k) clearances by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?panel=Orthopedic&record_type=clearance) [Watch this exact filter](/v/fdapulse?panel=Orthopedic&record_type=clearance#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top orthopedic devices: recent FDA 510(k) clearances right now? | Record | Specialty | Type | Date | |---|---|---|---| | TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC | Orthopedic | 510(k) | 2026-10-09 | | Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd. | Orthopedic | 510(k) | 2026-09-27 | | F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho | Orthopedic | 510(k) | 2026-09-21 | | The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd. | Orthopedic | 510(k) | 2026-09-17 | | GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts | Orthopedic | 510(k) | 2026-09-11 | | AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd. | Orthopedic | 510(k) | 2026-10-02 | | Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations | Orthopedic | 510(k) | 2026-10-19 | | APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc. | Orthopedic | 510(k) | 2026-10-07 | | Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp. | Orthopedic | 510(k) | 2026-09-24 | | DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc. | Orthopedic | 510(k) | 2026-09-23 | | Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Co | Orthopedic | 510(k) | 2026-10-23 | | Tempo Plating System (K263407): 510(k) cleared for Pace Surgical | Orthopedic | 510(k) | 2026-10-23 | | Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc. | Orthopedic | 510(k) | 2026-10-22 | | ANTHEM™ Fracture System (K262779): 510(k) cleared for Globus Medical, Inc. | Orthopedic | 510(k) | 2026-10-23 | | Cerclage Wires;K-wires;Steinmann Pins (K262126): 510(k) cleared for MK Medical GmbH | Orthopedic | 510(k) | 2026-10-22 | | GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V. | Included in the full CSV with every column 🔒 Unlock all 53 records → | | M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A. | Included in the full CSV with every column 🔒 Unlock all 53 records → | | Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd. | Included in the full CSV with every column 🔒 Unlock all 53 records → | Browse 35 more matching record reports - [GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V.](/report/fdapulse/gannet-k262184-nl--k262184) - [M-Vizion Femoral Revision System Extension (K260173): 510(k) cleared for Medacta International S.A.](/report/fdapulse/m-vizion-femoral-revision-system-extension-k260173-ch--k260173) - [Unity Total Knee System, Unity Knee Cementless CR Femur (K261275): 510(k) cleared for Corin, Ltd.](/report/fdapulse/unity-total-knee-system-unity-knee-cementless-cr-femur-gb--k261275) - [TeKBrace Knotless Anchor (K263352): 510(k) cleared for TheraMicro](/report/fdapulse/tekbrace-knotless-anchor-k263352-tn--k263352) - [Park's Pectus System (K263269): 510(k) cleared for Tdm Co., Ltd.](/report/fdapulse/park-s-pectus-system-k263269-kr--k263269) - [Vantage Lumbar Decompression Kit (K263208): 510(k) cleared for SurGenTec, LLC](/report/fdapulse/vantage-lumbar-decompression-kit-k263208-fl--k263208) - [prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (K263159): 510(k) cleared for Centinel Spine, LLC](/report/fdapulse/prodisc-c-prodisc-c-sk-prodisc-c-nova-prodisc-c-vivo-pa--k263159) - [AltiVate Reverse® Glenosphere with RAVN™ Technology (K263086): 510(k) cleared for Encore Medical L.P.](/report/fdapulse/altivate-reverse-glenosphere-with-ravn-technology-k263086-tx--k263086) - [ZSAlign Cervical Interbody System (K263113): 510(k) cleared for ZSFab, Inc.](/report/fdapulse/zsalign-cervical-interbody-system-k263113-ma--k263113) - [OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts (K263116): 510(k) cleared for OsteoCentric Technologies](/report/fdapulse/osteocentric-technologies-cannulated-and-soild-fasteners-ut--k263116) - [TDM Large Bone Plate and Screw System (K261611): 510(k) cleared for Tdm Co., Ltd.](/report/fdapulse/tdm-large-bone-plate-and-screw-system-k261611-kr--k261611) - [Response Ortho Smart Fixator - Hexapod System (K263083): 510(k) cleared for Response Ortho Solutions, LLC](/report/fdapulse/response-ortho-smart-fixator-hexapod-system-k263083-fl--k263083) - [NEXUS® Hip Stem (K262473): 510(k) cleared for Microport Orthopedics, Inc.](/report/fdapulse/nexus-hip-stem-k262473-tn--k262473) - [NOVIX Pedicle Screw System (K263062): 510(k) cleared for Tdm Co., Ltd.](/report/fdapulse/novix-pedicle-screw-system-k263062-kr--k263062) - [SAS MIS Pelvic Incidence Rods (K263172): 510(k) cleared for Spinal Alignment Solutions, Inc.](/report/fdapulse/sas-mis-pelvic-incidence-rods-k263172-nc--k263172) - [Arthrex Beaming System (K262975): 510(k) cleared for Arthrex, Inc.](/report/fdapulse/arthrex-beaming-system-k262975-fl--k262975) - [OsseoFit Stemless Shoulder System (K262955): 510(k) cleared for Zimmer, Inc.](/report/fdapulse/osseofit-stemless-shoulder-system-k262955-in--k262955) - [SABER-C System (K263049): 510(k) cleared for Elevation Spine](/report/fdapulse/saber-c-system-k263049-ca--k263049) - [Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (K262646): 510(k) cleared for Alphatec Spine, Inc.](/report/fdapulse/calibrate-max-system-calibrate-nanotec-max-system-calibrate-ca--k262646) - [Odys-SI Screw (K262522): 510(k) cleared for Medyssey Co, Ltd.](/report/fdapulse/odys-si-screw-k262522-kr--k262522) - [Ntegrate Threaded Nail System (K261961): 510(k) cleared for Nvision Biomedical Technologies](/report/fdapulse/ntegrate-threaded-nail-system-k261961-tx--k261961) - [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](/report/fdapulse/minuteman-g6-mis-fusion-plate-minuteman-g5-mis-fusion-plate-ks--k261607) - [Duet™ Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC](/report/fdapulse/duet-spinal-fixation-system-k262712-in--k262712) - [NeckTune™ SA Cervical Cage (K262726): 510(k) cleared for Medyssey Co., Ltd.](/report/fdapulse/necktune-sa-cervical-cage-k262726-kr--k262726) - [Spinalogic Bone Growth Stimulator (K262721): 510(k) cleared for Djo, LLC](/report/fdapulse/spinalogic-bone-growth-stimulator-k262721-ca--k262721) - [Alians Forearm (K262649): 510(k) cleared for Newclip Technics](/report/fdapulse/alians-forearm-k262649-fr--k262649) - [corra® cervical plating system (K262149): 510(k) cleared for Carlsmed, Inc.](/report/fdapulse/corra-cervical-plating-system-k262149-ca--k262149) - [ProRib Fixation System (K261892): 510(k) cleared for Costa Surgical, Inc.](/report/fdapulse/prorib-fixation-system-k261892-az--k261892) - [G7® Acetabular System (K261453): 510(k) cleared for Zimmer Biomet](/report/fdapulse/g7-acetabular-system-k261453-in--k261453) - [iFuse Granite Onyx™ Implant System (K262067): 510(k) cleared for SI-BONE, Inc.](/report/fdapulse/ifuse-granite-onyx-implant-system-k262067-ca--k262067) - [EnHAnce PEEK Bunion System (K262098): 510(k) cleared for Nvision Biomedical Technologies](/report/fdapulse/enhance-peek-bunion-system-k262098-tx--k262098) - [TMC Implant Fixation System (K262963): 510(k) cleared for Treace Medical Concepts, Inc.](/report/fdapulse/tmc-implant-fixation-system-k262963-fl--k262963) - [Integrity Retractable Implant Inserter (6000127) (K261869): 510(k) cleared for Anika Therapeutics, Inc.](/report/fdapulse/integrity-retractable-implant-inserter-6000127-k261869-ma--k261869) - [FRAXION Spinal Fixation System (K262091): 510(k) cleared for Ortler Global Tibbi Gerecler Anonim Sirketi](/report/fdapulse/fraxion-spinal-fixation-system-k262091-tr--k262091) - [GMK Extension (K262057): 510(k) cleared for Medacta International SA](/report/fdapulse/gmk-extension-k262057-ch--k262057) More records in this hub: [page 2](/hub/fdapulse/specialty_type/orthopedic--510k-clearances/page/2) [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many orthopedic devices: recent FDA 510(k) clearances 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 devices: recent FDA 510(k) clearances? Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page. Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.