Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 30
- Latest Decision
- 2024-09-26
Clearances · page 10 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K241651 | Affixus Tibial and Antegrade Femoral Nailing System | Zimmer, Inc. | HSB | Class II | 2024-09-26 |
| K242299 | NovaBone Putty - Synthetic Bioactive Bone Graft | Novabone Products, LLC | MQV | Class II | 2024-09-25 |
| K242273 | Cove Putty, OsteoCove Putty | SeaSpine Orthopedics Corporation | MQV | Class II | 2024-09-25 |
| K233807 | LumiVy Lumbar IBF System | Vy Spine, LLC | MAX | Class II | 2024-09-24 |
| K241570 | Unity Total Knee System | Corin U.S.A. Limited | JWH | Class II | 2024-09-23 |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | Smith & Nephew, Inc. | JDS | Class II | 2024-09-20 |
| K241332 | aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device | Carlsmed, Inc. | MAX | Class II | 2024-09-20 |
| K242147 | Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2024-09-20 |
| K241709 | Pectus Blu Support Bar System | Biomet Microfixation | HRS | Class II | 2024-09-19 |
| K242509 | HAnano InterFuse(R) Modular Interbody | Next Orthosurgical | MAX | Class II | 2024-09-19 |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | Xelite Biomed , Ltd. | NDN | Class II | 2024-09-18 |
| K241769 | Response Ortho Metaphyseal Hinge Fixator System | Response Ortho Solutions, LLC | KTT | Class II | 2024-09-18 |
| K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | MAX | Class II | 2024-09-17 |
| K241942 | TriMed Bridge Plates | TriMed, Inc. | HRS | Class II | 2024-09-17 |
| K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | MEH | Class II | 2024-09-13 |
| K242401 | EXULT Knee Replacement System | Corentec Co., Ltd. | JWH | Class II | 2024-09-12 |
| K241695 | Extremity All Suture System | Field Orthopaedics | MBI | Class II | 2024-09-12 |
| K241438 | Signus Tetris St; Signus Tetris R St | Signus Medizintechnik GmbH | MAX | Class II | 2024-09-11 |
| K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | JWH | Class II | 2024-09-11 |
| K241010 | HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors | Depuy Mitek | MAI | Class II | 2024-09-11 |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS) | Stryker Corporation (Tornier, Inc.) | KWS | Class II | 2024-09-10 |
| K240233 | Pitkar Spinal Pedicle Screw System | S.H.Pitkar Orthotools Pvt. , Ltd. | NKB | Class II | 2024-09-09 |
| K242042 | TriALTIS Spine System | Medos International SARL | NKB | Class II | 2024-09-09 |
| K234044 | ACS® LD FB Knee System | Implantcast GmbH | JWH | Class II | 2024-09-06 |
| K242415 | TMC Compression Implant System | Treace Medical Concepts | JDR | Class II | 2024-09-06 |
| K241164 | IB3D PL Spinal System | Medicrea International S.A.S. (Medtronic) | MAX | Class II | 2024-09-06 |
| K234035 | COSINE Spacer | Globus Medical, Inc. | MAX | Class II | 2024-09-06 |
| K232996 | Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) | Shanghai Iatrical-Ti Technologies CO , Ltd. | MAX | Class II | 2024-09-06 |
| K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology | Nanovis, LLC | MAX | Class II | 2024-09-05 |
| K241356 | Fine Osteotomy | Bodycad Laboratories, Inc. | HRS | Class II | 2024-09-05 |
| K242069 | Eminent Spine Scoliosis Deformity Pedicle Screw System | Eminent Spine | NKB | Class II | 2024-09-03 |
| K240487 | EVOS Patella Plates | Smith & Nephew | HRS | Class II | 2024-09-03 |
| K241592 | Arthrex VAL and VAL KreuLock Compression Screw System | Arthrex, Inc. | HWC | Class II | 2024-08-31 |
| K241148 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | OYK | Class II | 2024-08-30 |
| K242249 | Conformity Stem Extension Line | United Orthopedic Corporation | LZO | Class II | 2024-08-30 |
| K240180 | Orthopeasia Spinal Fixation System | Orthopeasia Co., Ltd. | NKB | Class II | 2024-08-30 |
| K241326 | Cadence Ankle PSI System | 3D Systems, Inc. | OYK | Class II | 2024-08-30 |
| K242280 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips | Stryker Spine | MQV | Class II | 2024-08-29 |
| K242296 | VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK) | Ortho-Design (Pty), Ltd. | MBI | Class II | 2024-08-29 |
| K241932 | OSSIOfiber® Compression Staple | OSSIO , Ltd. | MNU | Class II | 2024-08-28 |
| K233816 | REDEMPTION Charcot Plating System | Vilex, LLC | HRS | Class II | 2024-08-28 |
| K241241 | Z1 Cemented Hip System | Orchard Medical Development, LLC | LZO | Class II | 2024-08-27 |
| K240318 | SITTER 3.5mm Versatile System | Bonebridge AG | HRS | Class II | 2024-08-23 |
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System | Tdm Co., Ltd. | HSB | Class II | 2024-08-22 |
| K241804 | TRIGEN INTERTAN 10S Nail System | Smith & Nephew, Inc. | JDS | Class II | 2024-08-22 |
| K234128 | Phantom Fibula Nail System | Paragon 28, Inc. | HSB | Class II | 2024-08-22 |
| K233566 | Montage-XT Settable, Resorbable Bone Putty | Orthocon, Inc. | MQV | Class II | 2024-08-21 |
| K242141 | TiLink-P SI Joint Fusion System | SurGenTec, LLC | OUR | Class II | 2024-08-21 |
| K241738 | PYXIS 3D Titanium Cervical Cage system | GS Medical Co., Ltd. | ODP | Class II | 2024-08-20 |
| K241504 | iFuse TORQ TNT Implant System | SI-BONE, Inc. | OUR | Class II | 2024-08-19 |
| K241282 | RibFix Titan Fixation System | Riverpoint Medical | HRS | Class II | 2024-08-19 |
| K241754 | NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate | Zimmer Switzerland Manufacturing GmbH | HRS | Class II | 2024-08-15 |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) | In2bones USA | HRS | Class II | 2024-08-13 |
| K241813 | SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System | Si-Technology, LLC | OUR | Class II | 2024-08-13 |
| K241328 | aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo® Transforaminal Lumbar Interbody Fusion device (TLIF); aprevo® Anterior Lumbar Interbody Fusion device with Interfixation (ALIF-X) | Carlsmed, Inc. | MAX | Class II | 2024-08-12 |
| K241846 | E3D-C Interbody System | Evolution Spine | OVE | Class II | 2024-08-12 |
| K233992 | Precision AI Surgical Planning System (PAI-SPS) | Precision AI Pty, Ltd. | QHE | Class II | 2024-08-05 |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JDI | Class II | 2024-08-02 |
| K241892 | Cortera Spinal Fixation System | Xtant Medical Holdings, Inc. | NKB | Class II | 2024-08-02 |
| K233601 | Fixone Meniscal Repair | Aju Pharm Co., Ltd. | MBI | Class II | 2024-08-02 |
| K241359 | Medline UNITE® MIS Foot Recon Screw System | Medline Industries, LP | HWC | Class II | 2024-08-02 |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS | Baxter Healthcare Corporation | MQV | Class II | 2024-08-02 |
| K240035 | TACTIX Vector Syndesmosis System | Vilex, LLC | HTN | Class II | 2024-08-01 |
| K233696 | DePuy Synthes Retrograde Femoral Nail Advanced System | DePuy Synthes | HSB | Class II | 2024-08-01 |
| K242055 | Freefix Forearm Plating System | Skeletal Dynamics, Inc. | HRS | Class II | 2024-08-01 |
| K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics , Ltd. | NKB | Class II | 2024-08-01 |
| K242046 | EXULT Knee Replacement System | Corentec Co., Ltd. | JWH | Class II | 2024-08-01 |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | MEH | Class II | 2024-08-01 |
| K241539 | Activmotion S | Newclip Technics | HRS | Class II | 2024-07-30 |
| K242050 | Montage Settable Bone Putty | Orthocon, Inc. | MQV | Class II | 2024-07-29 |
| K241464 | ARx® SAI Implant System | Life Spine, Inc. | OUR | Class II | 2024-07-29 |
| K241912 | BIOCHARGE | Nanofiber Solutions, LLC | MAI | Class II | 2024-07-29 |
| K240326 | Solar Lumbar Interbody Fusion System | Degen Medical, Inc. | MAX | Class II | 2024-07-29 |
| K233994 | VOLT Proximal Humerus 3.5 Plating System | Synthes GmbH | HRS | Class II | 2024-07-26 |
| K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation System | Pantheon Spinal | NKB | Class II | 2024-07-26 |
| K241864 | Grappler Interference Screw System | Paragon 28, Inc. | MBI | Class II | 2024-07-25 |
| K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | KWQ | Class II | 2024-07-24 |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | Clariance | NKB | Class II | 2024-07-24 |
| K241296 | Gaudi Proximal Humerus Plate | Netbiologics, LLC | HRS | Class II | 2024-07-23 |
| K241482 | Kinos Total Ankle System | Restor3D | HSN | Class II | 2024-07-22 |
| K240835 | Suture Button Repair System | Skeletal Dynamics, Inc. | MBI | Class II | 2024-07-19 |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | Spineart SA | OVD | Class II | 2024-07-18 |
| K233482 | Equinoxe® Central Screw Baseplate System | Exactech, Inc. | PHX | Class II | 2024-07-18 |
| K241467 | Stable-C Interbody System | Nexus Spine, LLC | OVE | Class II | 2024-07-17 |
| K241413 | sagAlign Lumbar Cage System (Various PNs) | Acuity Surgical Devices, LLC | MAX | Class II | 2024-07-17 |
| K234077 | SPIRA® Anterior Lumbar Spacers | Camber Spine Technologies | MAX | Class II | 2024-07-12 |
| K241018 | KLS Martin Orthopedic Implants - MR Conditional | KLS-Martin L.P. | HRS | Class II | 2024-07-12 |
| K241000 | ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System; | Depuy Ireland UC | JWH | Class II | 2024-07-11 |
| K241019 | aprevo® TLIF-C Articulating System | Carlsmed | MAX | Class II | 2024-07-09 |
| K241277 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | HWC | Class II | 2024-07-03 |
| K233574 | Total Wrist Arthroplasty System (TWA) | Skeletal Dynamics | JWJ | Class II | 2024-07-03 |
| K241577 | Iconix® Anchor | Riverpoint Medical | MBI | Class II | 2024-07-03 |
| K241574 | iFuse TORQ® Implant System | SI-BONE, Inc. | OUR | Class II | 2024-07-02 |
| K240863 | Freedom® Total Knee System | Maxx Orthopedics, Inc. | JWH | Class II | 2024-07-02 |
| K240893 | ARTFX MEDICAL Cervical PEEK Cages | Artfx Medical | ODP | Class II | 2024-06-28 |
| K240381 | CATALYSTEM Femoral Stems | Smith & Nephew, Inc. | LZO | Class II | 2024-06-27 |
| K241212 | MagnetOs Easypack Putty | Kuros Biosciences | MQV | Class II | 2024-06-27 |
| K240938 | The Optimotion Blue Plus Knee System | Optimotion Implants, LLC | MBH | Class II | 2024-06-27 |
| K240327 | UNIKO PointCloud Knee Instruments | Unik Orthopedics, Inc. | JWH | Class II | 2024-06-27 |
| K240875 | Unity Knee PS-C Tibial Insert | Corin U.S.A. Limited | JWH | Class II | 2024-06-26 |
17,115 clearances in the Orthopedic panel. Data: openFDA.