# FDA Orthopedic device clearances: 1,061 since Nov 2024

Updated October 29, 2026.

FDA made 1,061 device decisions in orthopedic (FDA review panel) from November 12, 2024 to October 29, 2026: 858 510(k) clearances and De Novo grants and 203 PMA approvals and supplements, for 393 applicants. The newest, K263628 on October 29, 2026, is ELEOS™ Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C) from Onkos Surgical, Inc..

## The full list

FDA orthopedic device clearances and approvals: 1,061 rows for $53.05, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 51 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

Buy: https://specstream.ai/data/fda-clearances/panel/orthopedic

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 1,061
- 510(k) and De Novo: 858
- PMA: 203
- Latest decision: October 29, 2026

## Newest decisions

The newest 100 of 1,061, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 29, 2026 | K263628 | ELEOS™ Limb Salvage System with NanoCept® Technology (Proximal Tibia) (AM-25002200-C) | Onkos Surgical, Inc. | New Jersey | Substantially Equivalent | 510(k) special | QZZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263628) |
| October 29, 2026 | K263602 | Arthrex Plates, Screws and Pins, and Washers | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263602) |
| October 29, 2026 | K263582 | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | Switzerland | Substantially Equivalent | 510(k) special | KYJ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263582) |
| October 29, 2026 | K263065 | MicroPort Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263065) |
| October 29, 2026 | K262960 | Cerclage Cabling System | Pioneer Surgical Technology, Inc. dba EXALTA Group | Michigan | Substantially Equivalent | 510(k) traditional | JDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262960) |
| October 29, 2026 | K262731 | Virata Spinal Fixation System | SeaSpine Orthopedics Corporation | California | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262731) |
| October 29, 2026 | K262574 | Convoy Expandable Corpectomy System | SeaSpine Orthopedics Corporation | California | Substantially Equivalent | 510(k) traditional | MQP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262574) |
| October 29, 2026 | K262572 | Symmetrix™ PX Spinal System | Medtronic Sofamor Danek USA, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262572) |
| October 29, 2026 | K260975 | Libertas Acetabular Liners (Acetabular Liner) | Maxx Orthopedics, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | JDI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260975) |
| October 28, 2026 | K263583 | Tornier Humeral Reconstruction System (HRS) Tuberosity Body | Tornier, Inc. | Minnesota | Substantially Equivalent | 510(k) special | KWS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263583) |
| October 27, 2026 | P830055/S381 | ATTUNE Rotating Platform (RP) Total Knee System, and ATTUNE Revision Rotating Platform (RP) Knee System | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S381) |
| October 27, 2026 | P830055/S378 | LCS® Knee System | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S378) |
| October 27, 2026 | K263477 | Arthrex FiberButton | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263477) |
| October 26, 2026 | P010014/S120 | Oxford Partial Knee System | Biomet Manufacturing Corp | Indiana | 30-day notice accepted | PMA 30-day notice | NRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010014S120) |
| October 26, 2026 | K261135 | Trochlear Salvage Plating System | Skeletal Dynamics, Inc. | Florida | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261135) |
| October 23, 2026 | K263407 | Tempo Plating System | Pace Surgical | Pennsylvania | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263407) |
| October 23, 2026 | K263348 | Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor... | Smith & Nephew, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263348) |
| October 23, 2026 | K262779 | ANTHEM™ Fracture System | Globus Medical, Inc. | Pennsylvania | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262779) |
| October 22, 2026 | K263421 | Veritas Shoulder System | restor3d, inc. | North Carolina | Substantially Equivalent | 510(k) special | PHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263421) |
| October 22, 2026 | K262184 | GANNET® | BAAT Medical Products B.V. | Netherlands | Substantially Equivalent | 510(k) traditional | JDO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262184) |
| October 22, 2026 | K262126 | Cerclage Wires;K-wires;Steinmann Pins | MK Medical GmbH | Germany | Substantially Equivalent | 510(k) traditional | HTY | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262126) |
| October 21, 2026 | K263352 | TeKBrace Knotless Anchor | TheraMicro | Tennessee | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263352) |
| October 21, 2026 | K262646 | Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX... | Alphatec Spine, Inc. | California | Substantially Equivalent | 510(k) traditional | MAX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262646) |
| October 19, 2026 | K261189 | Freedom Nail Ankle Fusion System | McGinley Orthopaedic Innovations | Wyoming | Substantially Equivalent | 510(k) traditional | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261189) |
| October 16, 2026 | P060037/S100 | NexGen® LPS-Flex/LPS Mobile Bearing Knee System | Zimmer, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060037S100) |
| October 15, 2026 | K263269 | Park's Pectus System | Tdm Co., Ltd. | South Korea | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263269) |
| October 15, 2026 | K262522 | Odys-SI Screw | Medyssey Co, Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | OUR | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262522) |
| October 14, 2026 | K263208 | Vantage Lumbar Decompression Kit | SurGenTec, LLC | Florida | Substantially Equivalent | 510(k) special | HRX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263208) |
| October 14, 2026 | K261961 | Ntegrate Threaded Nail System | Nvision Biomedical Technologies | Texas | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261961) |
| October 9, 2026 | P830055/S379 | ATTUNE Revision Knee System | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S379) |
| October 9, 2026 | K260156 | TruVision Single-Use 1.9mm Arthroscopy System | Nexus CMF, LLC | Utah | Substantially Equivalent | 510(k) traditional | HRX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260156) |
| October 8, 2026 | P830055/S377 | ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Revision Rotating Platform (RP) Total Knee System... | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S377) |
| October 7, 2026 | K263159 | prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments | Centinel Spine, LLC | Pennsylvania | Substantially Equivalent | 510(k) special | QLQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263159) |
| October 7, 2026 | K261120 | APEX 3D S Diamond Tibia | Paragon 28, Inc. | Colorado | Substantially Equivalent | 510(k) traditional | HSN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261120) |
| October 6, 2026 | P010014/S119 | Cementless Oxford Partial Knee System | Biomet Manufacturing Corp | Indiana | 30-day notice accepted | PMA 30-day notice | NRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010014S119) |
| October 5, 2026 | P830055/S380 | LCS® Total Knee System | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S380) |
| October 2, 2026 | K263116 | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts | OsteoCentric Technologies | Utah | Substantially Equivalent | 510(k) special | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263116) |
| October 2, 2026 | K263113 | ZSAlign Cervical Interbody System | ZSFab, Inc. | Massachusetts | Substantially Equivalent | 510(k) special | OVE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263113) |
| October 2, 2026 | K263086 | AltiVate Reverse® Glenosphere with RAVN™ Technology | Encore Medical L.P. | Texas | Substantially Equivalent | 510(k) special | PHX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263086) |
| October 2, 2026 | K263083 | Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | Florida | Substantially Equivalent | 510(k) special | KTT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263083) |
| October 2, 2026 | K261611 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | South Korea | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261611) |
| October 2, 2026 | K261607 | Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA... | Spinal Simplicity, LLC | Kansas | Substantially Equivalent | 510(k) traditional | PEK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261607) |
| October 2, 2026 | K261217 | AnyPlus II Spinal Fixation System | GS Medical Co., Ltd. | South Korea | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261217) |
| October 1, 2026 | K263062 | NOVIX Pedicle Screw System | Tdm Co., Ltd. | South Korea | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263062) |
| October 1, 2026 | K262473 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | Tennessee | Substantially Equivalent | 510(k) special | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262473) |
| September 30, 2026 | K263172 | SAS MIS Pelvic Incidence Rods | Spinal Alignment Solutions, Inc. | North Carolina | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263172) |
| September 30, 2026 | K262712 | Duet™ Spinal Fixation System | Duet Spine Holdings, LLC | Indiana | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262712) |
| September 29, 2026 | K262726 | NeckTune™ SA Cervical Cage | Medyssey Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | OVE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262726) |
| September 29, 2026 | K262721 | Spinalogic Bone Growth Stimulator | Djo, LLC | California | Substantially Equivalent | 510(k) traditional | LOF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262721) |
| September 28, 2026 | K262649 | Alians Forearm | Newclip Technics | France | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262649) |
| September 27, 2026 | K252139 | Kentrospine Viktr-MIS® Pedicle screw system | Rivarp Medical Pvt., Ltd. | India | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252139) |
| September 25, 2026 | P830055/S375 | LCS® Total Knee System | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S375) |
| September 25, 2026 | K262975 | Arthrex Beaming System | Arthrex, Inc. | Florida | Substantially Equivalent | 510(k) special | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262975) |
| September 24, 2026 | P060037/S099 | NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System | Zimmer, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060037S099) |
| September 24, 2026 | K262955 | OsseoFit Stemless Shoulder System | Zimmer, Inc. | Indiana | Substantially Equivalent | 510(k) special | PKC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262955) |
| September 24, 2026 | K262149 | corra® cervical plating system | Carlsmed, Inc. | California | Substantially Equivalent | 510(k) traditional | KWQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262149) |
| September 24, 2026 | K261345 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | Indiana | Substantially Equivalent | 510(k) traditional | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261345) |
| September 23, 2026 | K263049 | SABER-C System | Elevation Spine | California | Substantially Equivalent | 510(k) special | OVE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K263049) |
| September 23, 2026 | K262067 | iFuse Granite Onyx™ Implant System | SI-BONE, Inc. | California | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262067) |
| September 23, 2026 | K261892 | ProRib Fixation System | Costa Surgical, Inc. | Arizona | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261892) |
| September 23, 2026 | K261453 | G7® Acetabular System | Zimmer Biomet | Indiana | Substantially Equivalent | 510(k) traditional | LPH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261453) |
| September 23, 2026 | K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | Georgia | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260995) |
| September 22, 2026 | P250042/S002 | BAGUERA®C Cervical Disc Prosthesis | Spineart USA, Inc. | California | Approved | PMA 180-day supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250042S002) |
| September 21, 2026 | P830055/S351 | Attune Revision Knee System | Depuy, Inc. | Indiana | Approved | PMA 180-day supplement | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S351) |
| September 21, 2026 | K254280 | F.A.S.T Screw | Steps Ortho | France | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254280) |
| September 18, 2026 | K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | Texas | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262098) |
| September 17, 2026 | P250028/S003 | Synergy Disc | Synergy Spine Solutions, Inc. | Colorado | Approved | PMA real-time process supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P250028S003) |
| September 17, 2026 | K262091 | FRAXION Spinal Fixation System | Ortler Global Tibbi Gerecler Anonim Sirketi | Turkey | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262091) |
| September 17, 2026 | K261869 | Integrity Retractable Implant Inserter (6000127) | Anika Therapeutics, Inc. | Massachusetts | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261869) |
| September 17, 2026 | K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | United Kingdom | Substantially Equivalent | 510(k) traditional | MBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261275) |
| September 17, 2026 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | Switzerland | Substantially Equivalent | 510(k) traditional | LZO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260173) |
| September 17, 2026 | K254260 | The VEGA Cervical Screw System | GS Medical Co., Ltd. | South Korea | Substantially Equivalent | 510(k) traditional | NKG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254260) |
| September 16, 2026 | P240001/S003 | PearlMatrixTM Peptide Enhanced Bone Graft | Cerapedics, Inc. | Colorado | 30-day notice accepted | PMA 30-day notice | NOX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240001S003) |
| September 16, 2026 | P140019/S014 | i-F ACTOR® Peptide Enhanced Graft Substitute | Cerapedics, LLC | Colorado | 30-day notice accepted | PMA 30-day notice | NOX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140019S014) |
| September 16, 2026 | P110009/S040 | Mobi-C® Cervical Disc Prosthesis for use at Two Levels | Highridge Medical, LLC | Colorado | 30-day notice accepted | PMA 30-day notice | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110009S040) |
| September 16, 2026 | P110002/S040 | Mobi-C® Cervical Disc Prosthesis for use at One Level | Highridge Medical, LLC | Colorado | 30-day notice accepted | PMA 30-day notice | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110002S040) |
| September 15, 2026 | K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | Florida | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262963) |
| September 15, 2026 | K262057 | GMK Extension | Medacta International SA | Switzerland | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262057) |
| September 14, 2026 | K262193 | RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System... | Xenix Medical | Florida | Substantially Equivalent | 510(k) traditional | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262193) |
| September 11, 2026 | K262230 | Mg OSTEOREVIVE™;Mg OSTEOCRETE™ | Bone Solutions, Inc. | Texas | Substantially Equivalent | 510(k) traditional | MQV | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262230) |
| September 11, 2026 | K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium... | INNO Holdings Inc. DBA Innovasis | Utah | Substantially Equivalent | 510(k) traditional | OVD | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262025) |
| September 11, 2026 | K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | Massachusetts | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260063) |
| September 10, 2026 | P830055/S376 | Attune Rotating Platform (RP) Total Knee System and the DePuy P.F.C.™ Sigma™ Rotating Platform (RP) Total... | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S376) |
| September 10, 2026 | K262293 | EVOLUTION MPX™ Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | China | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262293) |
| September 9, 2026 | P830055/S372 | ATTUNE Rotating Platform (RP) Total Knee System, ATTUNE Cementless Rotating Platform (RP) Knee System, ATTUNE... | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S372) |
| September 9, 2026 | P220002/S011 | TOPS™ System | Premia Spine, Ltd. |  | 30-day notice accepted | PMA 30-day notice | QWK | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220002S011) |
| September 9, 2026 | P070001/S031 | prodisc® C Nova | Centinel Spine, LLC | Pennsylvania | Approved | PMA 180-day supplement | MJO | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070001S031) |
| September 8, 2026 | K262341 | b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem... | B-One Ortho, Corp. | New Jersey | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262341) |
| September 8, 2026 | K262173 | N22 Offset Humeral Head | Shoulder Innovations, Inc. | Michigan | Substantially Equivalent | 510(k) traditional | KWT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262173) |
| September 8, 2026 | K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | Tennessee | Substantially Equivalent | 510(k) traditional | MBH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261462) |
| September 4, 2026 | P980044/S067 | SUPARTZ FX | Seikagaku Corp. |  | Approved | PMA 135-day supplement | MOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980044S067) |
| September 4, 2026 | P080020/S056 | Gel-One | Seikagaku Corp. |  | Approved | PMA 135-day supplement | MOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080020S056) |
| September 4, 2026 | P070026/S129 | CERAMAX CERAMIC HIP SYSTEM | DePuy Orthopaedics, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | MRA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P070026S129) |
| September 4, 2026 | K262828 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.m.a.i.o | France | Substantially Equivalent | 510(k) special | NKB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262828) |
| September 4, 2026 | K262130 | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | Indiana | Substantially Equivalent | 510(k) traditional | JWH | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262130) |
| September 4, 2026 | K261057 | ActivaScrew™ Cannulated COM | Bioretec, Ltd. | Finland | Substantially Equivalent | 510(k) traditional | HWC | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261057) |
| September 3, 2026 | P830055/S374 | LCS(R) TOTAL KNEE SYSTEM, specifically ATTUNE™ Cruciate Retaining (CR), Posterior Stabilized (PS) and... | Depuy, Inc. | Indiana | 30-day notice accepted | PMA 30-day notice | NJL | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P830055S374) |
| September 3, 2026 | K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | Pennsylvania | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261647) |
| September 2, 2026 | P010029/S043 | EUFLEXXA® (1% sodium hyaluronate) | Ferring Pharmaceuticals, Inc. | New Jersey | 30-day notice accepted | PMA 30-day notice | MOZ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P010029S043) |
| September 2, 2026 | K262809 | ArthroTAK Tendon Anchor Kit | ArthroTAK, LLC | Montana | Substantially Equivalent | 510(k) special | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262809) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| Depuy, Inc. | 46 | October 27, 2026 |
| Arthrex, Inc. | 34 | October 29, 2026 |
| Zimmer, Inc. | 25 | October 16, 2026 |
| Medtronic Sofamor Danek USA, Inc. | 22 | October 29, 2026 |
| Smith & Nephew, Inc. | 21 | October 23, 2026 |
| Medacta International S.A. | 18 | September 17, 2026 |
| Globus Medical, Inc. | 16 | October 23, 2026 |
| DePuy Orthopaedics, Inc. | 16 | September 4, 2026 |
| Biomet Manufacturing Corp | 15 | October 26, 2026 |
| TriMed, Inc. | 15 | August 12, 2026 |
| Maxx Orthopedics, Inc. | 12 | October 29, 2026 |
| Centinel Spine, LLC | 12 | October 7, 2026 |
| Paragon 28, Inc. | 12 | October 7, 2026 |
| Highridge Medical, LLC | 11 | September 16, 2026 |
| Carlsmed, Inc. | 10 | September 24, 2026 |
| Seikagaku Corp. | 10 | September 4, 2026 |
| Encore Medical L.P. | 9 | October 2, 2026 |
| L&K BIOMED Co., Ltd. | 9 | August 18, 2026 |
| ZheJiang Decans Medical Devices Co., Ltd. | 9 | June 16, 2026 |
| Signature Orthopaedics Pty, Ltd. | 9 | March 12, 2026 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 643 | October 29, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 202 | October 29, 2026 |
| [PMA 30-day notice](https://specstream.ai/data/fda-clearances/decision/pma-30-day-notice) | 126 | October 27, 2026 |
| [PMA 180-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-180-day-supplement) | 42 | September 22, 2026 |
| [510(k) abbreviated](https://specstream.ai/data/fda-clearances/decision/510k-abbreviated) | 9 | May 9, 2026 |
| [PMA real-time process supplement](https://specstream.ai/data/fda-clearances/decision/pma-real-time-process-supplement) | 8 | September 17, 2026 |
| [PMA 135-day supplement](https://specstream.ai/data/fda-clearances/decision/pma-135-day-supplement) | 8 | September 4, 2026 |
| [PMA special supplement](https://specstream.ai/data/fda-clearances/decision/pma-special-supplement) | 8 | June 29, 2026 |
| [PMA original approval](https://specstream.ai/data/fda-clearances/decision/pma-original-approval) | 7 | August 10, 2026 |
| [De Novo](https://specstream.ai/data/fda-clearances/decision/de-novo) | 4 | August 21, 2026 |
| [PMA panel track supplement](https://specstream.ai/data/fda-clearances/decision/pma-panel-track-supplement) | 4 | February 13, 2026 |

## By state or country

| State or country | Decisions | Latest |
| --- | --- | --- |
| [Indiana](https://specstream.ai/data/fda-clearances/state/indiana) | 128 | October 27, 2026 |
| [Florida](https://specstream.ai/data/fda-clearances/state/florida) | 92 | October 29, 2026 |
| [California](https://specstream.ai/data/fda-clearances/state/california) | 90 | October 29, 2026 |
| [Pennsylvania](https://specstream.ai/data/fda-clearances/state/pennsylvania) | 66 | October 29, 2026 |
| [Tennessee](https://specstream.ai/data/fda-clearances/state/tennessee) | 65 | October 29, 2026 |
| [Texas](https://specstream.ai/data/fda-clearances/state/texas) | 54 | October 14, 2026 |
| [Switzerland](https://specstream.ai/data/fda-clearances/country/switzerland) | 52 | October 29, 2026 |
| [Colorado](https://specstream.ai/data/fda-clearances/state/colorado) | 40 | October 7, 2026 |
| [South Korea](https://specstream.ai/data/fda-clearances/country/south-korea) | 38 | October 15, 2026 |
| [France](https://specstream.ai/data/fda-clearances/country/france) | 35 | September 28, 2026 |
| [New Jersey](https://specstream.ai/data/fda-clearances/state/new-jersey) | 29 | October 29, 2026 |
| [Massachusetts](https://specstream.ai/data/fda-clearances/state/massachusetts) | 27 | October 23, 2026 |
| [China](https://specstream.ai/data/fda-clearances/country/china) | 24 | October 29, 2026 |
| [Germany](https://specstream.ai/data/fda-clearances/country/germany) | 20 | October 22, 2026 |
| [Utah](https://specstream.ai/data/fda-clearances/state/utah) | 20 | October 9, 2026 |
| [North Carolina](https://specstream.ai/data/fda-clearances/state/north-carolina) | 17 | October 22, 2026 |
| [Taiwan](https://specstream.ai/data/fda-clearances/country/taiwan) | 15 | September 2, 2026 |
| [Italy](https://specstream.ai/data/fda-clearances/country/italy) | 15 | May 19, 2026 |
| [Australia](https://specstream.ai/data/fda-clearances/country/australia) | 14 | May 26, 2026 |
| [Minnesota](https://specstream.ai/data/fda-clearances/state/minnesota) | 12 | October 28, 2026 |
| [Illinois](https://specstream.ai/data/fda-clearances/state/illinois) | 12 | July 28, 2026 |
| [Oregon](https://specstream.ai/data/fda-clearances/state/oregon) | 11 | August 27, 2026 |
| [Brazil](https://specstream.ai/data/fda-clearances/country/brazil) | 11 | August 19, 2026 |
| [Israel](https://specstream.ai/data/fda-clearances/country/israel) | 10 | August 5, 2026 |
| [Michigan](https://specstream.ai/data/fda-clearances/state/michigan) | 9 | October 29, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).