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Orthopedic FDA 510(k) clearances, last 90 days

US companies with an FDA 510(k) clearance in Orthopedic from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.

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Last 90 days

71 clearances in the last 90 days. The same 90 days a year earlier: 69.

For contract manufacturers and test labs

Orthopedic accounts for 71 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is HRS (Plate, Fixation, Bone). Contract manufacturers and test labs that work on Orthopedic devices can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.

Top product codes

Product codeDevice typeClearances
HRSPlate, Fixation, Bone8
MBIFastener, Fixation, Nondegradable, Soft Tissue8
HWCScrew, Fixation, Bone6
NKBThoracolumbosacral Pedicle Screw System5
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4
71 clearances, Aug 2, 2026 to Oct 30, 2026.
Decision dateCompanyDeviceFDA record
Oct 29, 2026Onkos Surgical, Inc.ELEOS™ Limb Salvage System with NanoCept Technology (Proximal Tibia) (AM-25002200-C)K263628
Oct 29, 2026Arthrex, Inc.Arthrex Plates, Screws and Pins, and WashersK263602
Oct 29, 2026Pioneer Surgical Technology, Inc. dba EXALTA GroupCerclage Cabling SystemK262960
Oct 29, 2026SeaSpine Orthopedics CorporationVirata Spinal Fixation SystemK262731
Oct 29, 2026SeaSpine Orthopedics CorporationConvoy Expandable Corpectomy SystemK262574
Oct 29, 2026Medtronic Sofamor Danek USA, Inc.Symmetrix™ PX Spinal SystemK262572
Oct 29, 2026Maxx Orthopedics, Inc.Libertas Acetabular Liners (Acetabular Liner)K260975
Oct 28, 2026Tornier, Inc.Tornier Humeral Reconstruction System (HRS) Tuberosity BodyK263583
Oct 27, 2026Arthrex, Inc.Arthrex FiberButtonK263477
Oct 26, 2026Skeletal Dynamics, Inc.Trochlear Salvage Plating SystemK261135
Oct 23, 2026Pace SurgicalTempo Plating SystemK263407
Oct 23, 2026Smith & Nephew, Inc.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, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINITK263348
Oct 23, 2026Globus Medical, Inc.ANTHEM™ Fracture SystemK262779
Oct 22, 2026restor3d, inc.Veritas Shoulder SystemK263421
Oct 21, 2026TheraMicroTeKBrace Knotless AnchorK263352
Oct 21, 2026Alphatec Spine, Inc.Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody SystemK262646
Oct 19, 2026McGinley Orthopaedic InnovationsFreedom Nail Ankle Fusion SystemK261189
Oct 14, 2026SurGenTec, LLCVantage Lumbar Decompression KitK263208
Oct 14, 2026Nvision Biomedical TechnologiesNtegrate Threaded Nail SystemK261961
Oct 9, 2026Nexus CMF, LLCTruVision Single-Use 1.9mm Arthroscopy SystemK260156
Oct 7, 2026Centinel Spine, LLCprodisc C; prodisc C SK; prodisc C Nova; prodisc C Vivo InstrumentsK263159
Oct 7, 2026Paragon 28, Inc.APEX 3D S Diamond TibiaK261120
Oct 2, 2026OsteoCentric TechnologiesOsteoCentric Technologies Cannulated and Soild Fasteners with NutsK263116
Oct 2, 2026ZSFab, Inc.ZSAlign Cervical Interbody SystemK263113
Oct 2, 2026Encore Medical L.P.AltiVate Reverse Glenosphere with RAVN™ TechnologyK263086
  • Oct 29, 2026
    Onkos Surgical, Inc.

    ELEOS™ Limb Salvage System with NanoCept Technology (Proximal Tibia) (AM-25002200-C)

    K263628
  • Oct 29, 2026
    Arthrex, Inc.

    Arthrex Plates, Screws and Pins, and Washers

    K263602
  • Oct 29, 2026
    Pioneer Surgical Technology, Inc. dba EXALTA Group

    Cerclage Cabling System

    K262960
  • Oct 29, 2026
    SeaSpine Orthopedics Corporation

    Virata Spinal Fixation System

    K262731
  • Oct 29, 2026
    SeaSpine Orthopedics Corporation

    Convoy Expandable Corpectomy System

    K262574
  • Oct 29, 2026
    Medtronic Sofamor Danek USA, Inc.

    Symmetrix™ PX Spinal System

    K262572
  • Oct 29, 2026
    Maxx Orthopedics, Inc.

    Libertas Acetabular Liners (Acetabular Liner)

    K260975
  • Oct 28, 2026
    Tornier, Inc.

    Tornier Humeral Reconstruction System (HRS) Tuberosity Body

    K263583
  • Oct 27, 2026
    Arthrex, Inc.

    Arthrex FiberButton

    K263477
  • Oct 26, 2026
    Skeletal Dynamics, Inc.

    Trochlear Salvage Plating System

    K261135
  • Oct 23, 2026
    Pace Surgical

    Tempo Plating System

    K263407
  • Oct 23, 2026
    Smith & Nephew, Inc.

    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, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Black knotless and one Blue MINITAPE Suture; Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one Blue knotless and one Black MINIT

    K263348
  • Oct 23, 2026
    Globus Medical, Inc.

    ANTHEM™ Fracture System

    K262779
  • Oct 22, 2026
    restor3d, inc.

    Veritas Shoulder System

    K263421
  • Oct 21, 2026
    TheraMicro

    TeKBrace Knotless Anchor

    K263352
  • Oct 21, 2026
    Alphatec Spine, Inc.

    Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System

    K262646
  • Oct 19, 2026
    McGinley Orthopaedic Innovations

    Freedom Nail Ankle Fusion System

    K261189
  • Oct 14, 2026
    SurGenTec, LLC

    Vantage Lumbar Decompression Kit

    K263208
  • Oct 14, 2026
    Nvision Biomedical Technologies

    Ntegrate Threaded Nail System

    K261961
  • Oct 9, 2026
    Nexus CMF, LLC

    TruVision Single-Use 1.9mm Arthroscopy System

    K260156
  • Oct 7, 2026
    Centinel Spine, LLC

    prodisc C; prodisc C SK; prodisc C Nova; prodisc C Vivo Instruments

    K263159
  • Oct 7, 2026
    Paragon 28, Inc.

    APEX 3D S Diamond Tibia

    K261120
  • Oct 2, 2026
    OsteoCentric Technologies

    OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts

    K263116
  • Oct 2, 2026
    ZSFab, Inc.

    ZSAlign Cervical Interbody System

    K263113
  • Oct 2, 2026
    Encore Medical L.P.

    AltiVate Reverse Glenosphere with RAVN™ Technology

    K263086

Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.

FAQ

Is a 510(k) an FDA approval?
No. The FDA clears a device through a 510(k) when it finds the device substantially equivalent to one already sold in the US.
Where do these rows come from?
From openFDA's 510(k) records, for K numbers Whimbrel already holds. Each K number links to the FDA 510(k) database.
Why do some review panels have no page?
A review panel page is published when the last 90 days have 10 or more US clearances in that panel.

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