Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 39
- Latest Decision
- 2026-02-20
Clearances · page 4 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K253660 | KLS Martin Pure Pectus System | KLS-Martin L.P. | HRS | Class II | 2026-02-20 |
| K254162 | KLS Martin Ixos System | KLS Martin L.P. | HRS | Class II | 2026-02-20 |
| K252733 | ATLAS Expandable Osteotomy Wedge System | MiRus, LLC | PLF | Class II | 2026-02-19 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | MBH | Class II | 2026-02-18 |
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | MAI | Class II | 2026-02-17 |
| K253524 | Adaptos®Fuse Bone Graft | Biomendex OY | MQV | Class II | 2026-02-17 |
| K254105 | Hive Standalone Cervical System and Hive C Interbody System | NanoHive Medical, LLC | ODP | Class II | 2026-02-13 |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | KWQ | Class II | 2026-02-12 |
| K251732 | Wrist Fracture System | Met One Technologies, LLC | HRS | Class II | 2026-02-12 |
| K253488 | iFuse INTRA Ti Implant System | SI-BONE, Inc. | OUR | Class II | 2026-02-11 |
| K253545 | Vulcan Spinal System | K2m, Inc. | NKB | Class II | 2026-02-10 |
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mm | Biodynamik, Inc. | JDW | Class II | 2026-02-10 |
| K250773 | Luna® Ti Interbody Fusion System | Spinal Elements, Inc. | MAX | Class II | 2026-02-04 |
| K260038 | E3D-C Interbody System | Evolution Spine | OVE | Class II | 2026-02-04 |
| K260104 | Signature ONE System | Orthosoft Inc. (d/b/a) Zimmer CAS | QHE | Class II | 2026-02-04 |
| K252623 | G7® Revision Acetabular System | Zimmer, Inc. | LPH | Class II | 2026-02-04 |
| K250644 | MSS - Monobloc stem | Medacta International S.A. | PHX | Class II | 2026-02-03 |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | HSB | Class II | 2026-02-03 |
| K253763 | Y-Knotless Flex Anchors | Conmed Corporation | MBI | Class II | 2026-01-29 |
| K253611 | Falco Fusion System | Mcnicoll Surgical, Inc. | OUR | Class II | 2026-01-29 |
| K260004 | Aevumed PROTEKT Suture Anchor | Aevumed, Inc. | MBI | Class II | 2026-01-28 |
| K252834 | Sacroiliac Joint Truss System (SJTS) | 4Web Medical | OUR | Class II | 2026-01-28 |
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. | NDN | Class II | 2026-01-28 |
| K251043 | Mpact 3D Metal Implants Extension DMLS Technology | Medacta International S.A. | LPH | Class II | 2026-01-28 |
| K253748 | Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2026-01-23 |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System | Lima Corporate S.P.A. | PHX | Class II | 2026-01-22 |
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | PML | Class II | 2026-01-22 |
| K254165 | Infinity OCT System | Medtronic Sofamor Danek USA, Inc. | NKG | Class II | 2026-01-21 |
| K253713 | Arthrex Variable Angle (VA) Proximal Tibia Plating System | Arthrex, Inc. | HRS | Class II | 2026-01-21 |
| K253291 | Excelsior System | Blue Ocean Global | KTT | Class II | 2026-01-20 |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | ODP | Class II | 2026-01-16 |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. | PHX | Class II | 2026-01-15 |
| K251961 | SDS Growing Rod | BAAT Medical Products B.V. | PGM | Class II | 2026-01-15 |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) | Maxx Orthopedics, Inc. | LZO | Class II | 2026-01-15 |
| K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) | TriMed, Inc. | HRS | Class II | 2026-01-15 |
| K252567 | AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. | PHX | Class II | 2026-01-15 |
| K254061 | Curiteva Porous PEEK Cervical Interbody Fusion System | Curiteva, Inc. | ODP | Class II | 2026-01-15 |
| K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | ODP | Class II | 2026-01-14 |
| K251214 | BEAR® (Bridge-Enhanced ACL Restoration) Implant | Miach Orthopaedics, Inc. | QNI | Class II | 2026-01-13 |
| K252461 | Swedge Pedicle Screw Fixation System Bezier Rod | Spinal Resources, Inc. | NKB | Class II | 2026-01-13 |
| K251558 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | QHE | Class II | 2026-01-12 |
| K252807 | Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates | Arthrex, Inc. | HRS | Class II | 2026-01-12 |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | PHX | Class II | 2026-01-09 |
| K253266 | Titanium Interbody System | Spine Innovation, LLC | MAX | Class II | 2026-01-08 |
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. | PHX | Class II | 2026-01-08 |
| K252711 | Advantage-C Ti3D Cervical Interbody Fusion Device | Intelivation Technologies | ODP | Class II | 2026-01-08 |
| K253158 | VyBrate VBR System | Vy Spine, LLC | MQP | Class II | 2026-01-07 |
| K253941 | CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly) | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2026-01-07 |
| K253990 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | 2026-01-07 |
| K253793 | Materialise TKA Guide System | Materialise NV | JWH | Class II | 2026-01-06 |
| K253178 | TRILEAP Plating System | Crossroads Extremity Systems | HRS | Class II | 2026-01-06 |
| K253618 | QuadLock Fixation System | Abanza Tecnomed S.L | MBI | Class II | 2026-01-06 |
| K252894 | aprevo® cervical interbody system | Carlsmed, Inc. | ODP | Class II | 2026-01-06 |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | HWC | Class II | 2025-12-31 |
| K253895 | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | Arthrex, Inc. | MBI | Class II | 2025-12-30 |
| K253325 | ZipToe Hammertoe Fusion System | Toetal Solutions | HTY | Class II | 2025-12-29 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | MBH | Class II | 2025-12-23 |
| K253217 | MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) | Medimaging Integrated Solution, Inc (Miis) | HRX | Class II | 2025-12-23 |
| K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | KWL | Class II | 2025-12-23 |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | KWQ | Class II | 2025-12-22 |
| K253876 | HEDRON Cervical Spacers (HEDRON C-MIS Spacer) | Globus Medical, Inc. | OVE | Class II | 2025-12-22 |
| K253727 | Syndesmosis TightRope PRO | Arthrex, Inc. | HTN | Class II | 2025-12-22 |
| K252974 | EMPOWR Knee | Encore Medical L.P. | JWH | Class II | 2025-12-19 |
| K253577 | IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter) | Medicrea International S.A.S. (Medtronic) | MAX | Class II | 2025-12-19 |
| K253202 | Hoffmann LRF System | Stryker GmbH | KTT | Class II | 2025-12-19 |
| K253613 | Monkey Rings External Ring Fixation System | Paragon 28, Inc. | KTT | Class II | 2025-12-19 |
| K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio | HRS | Class II | 2025-12-19 |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | MBH | Class II | 2025-12-19 |
| K252781 | MSFX MIKRON PEEK CAGES | Mikron Makina Sanayi VE Tic. Ltd. Sti. | ODP | Class II | 2025-12-19 |
| K253093 | Vital Spinal Fixation System | Highridge Medical, LLC | NKB | Class II | 2025-12-17 |
| K252191 | BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus System | Bonebridge AG | HRS | Class II | 2025-12-17 |
| K253721 | KHEIRON® Spinal Fixation System, including patient specific K-ROD | S.M.A.I.O | NKB | Class II | 2025-12-17 |
| K253118 | Companion Spine DIAM Instrumentation | Companion Spine France | QLR | Class II | 2025-12-16 |
| K251771 | Cambridge Partial Knee | Signature Orthopaedics Pty, Ltd. | HSX | Class II | 2025-12-16 |
| K251302 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | OQB | Class II | 2025-12-15 |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRO | Class II | 2025-12-15 |
| K253749 | Affixus® Natural Nail® Proximal Humeral System | Zimmer Switzerland Manufacturing GmbH | HSB | Class II | 2025-12-12 |
| K250988 | KLS Martin Pure Pectus System | KLS-Martin L.P. | HRS | Class II | 2025-12-11 |
| K252997 | HyperFlex® Bunion Correction System | Hyperflex Medical | HRS | Class II | 2025-12-11 |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA) | 4Web Medical, Inc. | OVE | Class II | 2025-12-11 |
| K252897 | APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw); APS Osteotomy Fixation System (0850-4302-xx / 5.0mm Locking Screw); APS Osteotomy Fixation System (0701-xx10(1)-05 / Proximal Medial Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0701-xx60(1)-0x / Proximal Medial Tibial Osteotomy Locking Plate, Small); APS Osteotomy Fixation System (0702-xx00(1)-03 / Proximal Lateral Tibial Osteotomy Locking Plate); APS Osteotomy Fixation System (0501-xx00(1)-04 / Dista | A Plus Biotechnology Co., Ltd. | HRS | Class II | 2025-12-11 |
| K252826 | ARIX Femur Nail System | Jeil Medical Corporation | HSB | Class II | 2025-12-10 |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | OVD | Class II | 2025-12-08 |
| K250764 | SpineLinc Anterior Cervical Implant System | Lincotek Medical | ODP | Class II | 2025-12-05 |
| K250711 | VSP Orthopedics System | 3D Systems, Inc. | PBF | Class II | 2025-12-05 |
| K250795 | PUREVUE FMS | W.O.M. World of Medicine GmbH | HRX | Class II | 2025-12-05 |
| K252067 | Velora Acetabular System | Restor3D, Inc. | LPH | Class II | 2025-12-05 |
| K252596 | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | Tigon Medical | MBI | Class II | 2025-12-04 |
| K253250 | Minuteman® G6 MIS Fusion Plate | Spinal Simplicity, LLC | PEK | Class II | 2025-12-01 |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants | Exactech, Inc. | KWT | Class II | 2025-12-01 |
| K252555 | Medusa Orthopedics Boa External Fixation System | Medusa Orthopedics, LLC | KTT | Class II | 2025-11-25 |
| K252610 | ZSFab Lumbar Interbody System | Zsfab, Inc. | MAX | Class II | 2025-11-25 |
| K250769 | Dakota LP System | Precision Spine, Inc. | ODP | Class II | 2025-11-24 |
| K250560 | BEE HA | NGMedical GmbH | ODP | Class II | 2025-11-21 |
| K252666 | Articulator Arthroscopic Bur | Joint Preservation Innovations, LLC | HRX | Class II | 2025-11-21 |
| K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | ODP | Class II | 2025-11-21 |
| K252846 | TaperSet Hip System | Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics | LPH | Class II | 2025-11-20 |
| K252625 | The Response Ortho Smart Fixator - Hexapod System | Response Ortho Solutions, LLC | KTT | Class II | 2025-11-20 |
| K251365 | OptumSI Implant System | Si Solutions, LLC | OUR | Class II | 2025-11-20 |
| K252661 | SternaFuse Ti Fixation System | Fusion Innovations, LLC | HRS | Class II | 2025-11-19 |
17,115 clearances in the Orthopedic panel. Data: openFDA.