Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 40
- Latest Decision
- 2022-08-16
Clearances · page 20 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222169 | FairFix Adjustable Button System | Medacta International S.A. | MBI | Class II | 2022-08-16 |
| K222082 | aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices | Carlsmed, Inc. | MAX | Class II | 2022-08-12 |
| K221049 | Zavation VariSync Plate System and VariSync Spacer System | Zavation Medical Products, LLC | OVE | Class II | 2022-08-12 |
| K222161 | Arthrex Knotless FiberTak Biceps Suture Anchor | Arthrex, Inc. | MBI | Class II | 2022-08-11 |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | MEH | Class II | 2022-08-11 |
| K221776 | NextGen Pedicle Screw System | Corelink, LLC | NKB | Class II | 2022-08-09 |
| K213791 | Unispace SA Cervical Cage | Edisoninno Co., Ltd. | OVE | Class II | 2022-08-05 |
| K221104 | Actera hip system | Conformis, Inc. | MEH | Class II | 2022-08-04 |
| K211614 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | PBF | Class II | 2022-08-04 |
| K213614 | Cannulated Screws | Maxxion Medical, LLC | HWC | Class II | 2022-08-03 |
| K213104 | Auxilock Titanium Screw-In Suture Anchor | Auxein Medical Private Limited | MBI | Class II | 2022-07-29 |
| K220901 | S-Core Implant System | Subchondral Solutions, Inc. | MBI | Class II | 2022-07-29 |
| K221905 | INERTIA CONNEXX Modular Pedicle Screw System | Nexxt Spine, LLC | NKB | Class II | 2022-07-28 |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener System | OsteoCentric Technologies | NKB | Class II | 2022-07-28 |
| K221687 | Pegasus-X Expandable PLIF System | GS Medical Co., Ltd. | MAX | Class II | 2022-07-27 |
| K211496 | TransLoc 3D | Foundation Fusion Solutions, LLC (Dba Cornerloc) | OUR | Class II | 2022-07-27 |
| K211385 | KeriFlex® MCP and PIP Finger Joint Prostheses | Keri Medical SA | KYJ | Class II | 2022-07-27 |
| K221572 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | KWQ | Class II | 2022-07-26 |
| K221939 | Cemented Round Patella with JRNY Pegs | Smith & Nephew, Inc. | JWH | Class II | 2022-07-26 |
| K221502 | Parcus Synd-EZ SS | Parcus Medical, LLC | MBI | Class II | 2022-07-26 |
| K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Conformis, Inc. | JWH | Class II | 2022-07-26 |
| K220216 | C-Stem AMT LE Prosthesis | Depuy Ireland UC | JDI | Class II | 2022-07-22 |
| K220486 | Kentrospine PSS Pedicle Screw System | Rivarp Medical Private Limited | NKB | Class II | 2022-07-22 |
| K220906 | SECURE-LOCK | Xiros, Ltd. | HTY | Class II | 2022-07-22 |
| K211891 | DM Converter - TiN coated | Medacta International S.A. | LZO | Class II | 2022-07-22 |
| K221535 | Align Lumbar Interbody Fusion System | Acuity Surgical Devices, LLC | MAX | Class II | 2022-07-22 |
| K221794 | Vario-Cup System | Waldemar Link GmbH & Co. KG | KWY | Class II | 2022-07-20 |
| K220679 | Pediatric Nailing Platform Femur | OrthoPediatrics Corp. | HSB | Class II | 2022-07-20 |
| K221364 | Mitek TIGHT-N Anchor | Medos International SARL | MBI | Class II | 2022-07-11 |
| K221399 | ZIP MIS Interspinous Fusion System | Aurora Spine, Inc. | PEK | Class II | 2022-07-08 |
| K221346 | Stryker VariAx 2 MIS Calcaneus | Stryker GmbH | HRS | Class II | 2022-07-08 |
| K213387 | AltiVate® Anatomic Shoulder AG e+ with Markers | Encore Medical L.P. | KWS | Class II | 2022-07-07 |
| K212815 | My3D® Personalized Pelvic Reconstruction | Onkos Surgical | LPH | Class II | 2022-07-06 |
| K221337 | Materialise TKA Guide System | Materialise NV | JWH | Class II | 2022-07-05 |
| K211176 | Smith & Nephew Hip Systems | Smith & Nephew, Inc. | LPH | Class II | 2022-07-01 |
| K221395 | Footmotion Plating System | Newclip Technics | HRS | Class II | 2022-07-01 |
| K213871 | Ennovate Cervical Spinal and Occiput System | Aesculap Implant Systems, LLC | NKG | Class II | 2022-07-01 |
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System | Aegis Spine, Inc. | OUR | Class II | 2022-06-30 |
| K220937 | Arthrex Mini Fragment System | Arthrex, Inc. | HRS | Class II | 2022-06-29 |
| K221195 | OsteoProbe | Active Life Scientific, Inc. | QGQ | Class II | 2022-06-28 |
| K211076 | Patient Specific Marking Guides | Additive Orthopaedics, LLC | PBF | Class II | 2022-06-28 |
| K221256 | Mg OSTEOINJECT | Bone Solutions, Inc. | MQV | Class II | 2022-06-28 |
| K220449 | DePuy CONDUIT LLIF SQUID Inserter | Enztec Limited | MAX | Class II | 2022-06-28 |
| K211718 | Venus Cervical Plate System | Artfx Medical, LLC | KWQ | Class II | 2022-06-28 |
| K214123 | T-FIX® 3DSI Joint Fusion System | Cutting Edge Spine, LLC | OUR | Class II | 2022-06-24 |
| K213349 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | PHX | Class II | 2022-06-23 |
| K201788 | EDEN Spinal Fixation System | Jmt Co., Ltd. | NKB | Class II | 2022-06-23 |
| K220413 | Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System | Canary Medical USA, LLC | QPP | Class II | 2022-06-22 |
| K211877 | Klassic Knee System | Total Joint Orthopedics, Inc. | JWH | Class II | 2022-06-22 |
| K220478 | NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2022-06-21 |
| K220523 | restor3d TiDAL Lumbar Interbody Fusion Device | Restor3D | MAX | Class II | 2022-06-17 |
| K221465 | Baby Gorilla/Gorilla Plating System | Paragon 28, Inc. | HRS | Class II | 2022-06-17 |
| K201348 | DePuy 3D Additive TriFlange Acetabular Cup | Depuy International, Ltd. | LPH | Class II | 2022-06-16 |
| K212870 | TLC Unicompartmental Knee System | Signature Orthopaedics Pty, Ltd. | HSX | Class II | 2022-06-16 |
| K210582 | EasyClip® and EasyClip® Xpress | Stryker GmbH | JDR | Class II | 2022-06-10 |
| K221362 | Omni Foot and Ankle Plating System | Exremity Medical, LLC | HRS | Class II | 2022-06-10 |
| K213667 | iFuse-TORQ® Implant System | SI-BONE, Inc. | OUR | Class II | 2022-06-10 |
| K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System | Stryker GmbH | HWC | Class II | 2022-06-10 |
| K220717 | RedPoint Medical's Better Bunion System | Redpoint Medical, LLC | PBF | Class II | 2022-06-09 |
| K220782 | IdentiTi Porous Ti Interbody System, IdentiTi NanoTec Interbody System, Transcend PEEK Interbody System, Transcend NanoTec Interbody System, IdentiTi ALIF Standalone Interbody System, IdentiTi NanoTec ALIF Standalone Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2022-06-09 |
| K211981 | KHEIRON® Spinal Fixation System | S.M.A.I.O | NKB | Class II | 2022-06-09 |
| K212933 | INHANCETM Hybrid Anatomic Glenoid Implant | Depuy Ireland UC | MBF | Class II | 2022-06-08 |
| K221389 | FairFix AM Adjustable Button FairFix PSP Adjustable Button | Medacta International S.A. | MBI | Class II | 2022-06-08 |
| K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | PHX | Class II | 2022-06-07 |
| K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins | Wishbone Medical, Inc. | KTT | Class II | 2022-06-06 |
| K212450 | Keos Anterior Cervical Interbody Fusion Device System | Keos | ODP | Class II | 2022-06-06 |
| K220947 | Arthrex Knotless AC Repair Devices | Arthrex, Inc. | HTN | Class II | 2022-06-06 |
| K211567 | BiMobile Instruments (for BiMobile Dual Mobility System) | Waldemar Link GmbH & Co. KG | LZO | Class II | 2022-06-03 |
| K220861 | M6-C Artificial Cervical Disc Instruments AS | Spinal Kinetics, LLC | QLQ | Class II | 2022-06-02 |
| K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | HSX | Class II | 2022-06-02 |
| K220581 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | MAX | Class II | 2022-06-02 |
| K203233 | 4CIS Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | NKB | Class II | 2022-06-01 |
| K220650 | TriMed Ripcord Device | TriMed, Inc. | HTN | Class II | 2022-06-01 |
| K212729 | Bone Cement-Normal Viscosity | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | LOD | Class II | 2022-05-31 |
| K220610 | SOLO-L | Aurora Spine, Inc. | OVD | Class II | 2022-05-27 |
| K220902 | Navagio Lumbar Cage | Kalitec Medical, LLC | MAX | Class II | 2022-05-27 |
| K213698 | CoLink PCR Plating System | In2bones USA, LLC | HRS | Class II | 2022-05-27 |
| K220195 | iFuse Bedrock Granite Implant System | SI-BONE, Inc. | OUR | Class II | 2022-05-26 |
| K221244 | CD Horizon Spinal System | Medtronic | NKB | Class II | 2022-05-25 |
| K201393 | restor3d MTP Implant | Restor3D, Inc. | KWD | Class II | 2022-05-25 |
| K210614 | BENCOX Mirabo Z Cup Cortinium | Corentec Co., Ltd. | LPH | Class II | 2022-05-24 |
| K220888 | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | Medacta International S.A. | QSR | Class II | 2022-05-24 |
| K213659 | LigaPASS 2.0 Ligament Augmentation System | Medicrea International SA | OWI | Class II | 2022-05-24 |
| K212327 | M-Vizion Monobloc | Medacta International S.A. | LZO | Class II | 2022-05-24 |
| K212979 | CalcShift Displacement Calcaneal Osteotomy System | Nextremity Solutions, Inc. | HRS | Class II | 2022-05-20 |
| K221232 | Univers Revers Humeral Cup Implant | Arthrex, Inc. | HSD | Class II | 2022-05-19 |
| K220285 | PINE Pedicle Screw System | Tdm Co., Ltd. | NKB | Class II | 2022-05-19 |
| K220792 | SMR Reverse Liner | Lima Corporate S.P.A. | MBF | Class II | 2022-05-19 |
| K211869 | OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE | LOD | Class II | 2022-05-19 |
| K221135 | X-Twist PEEK Suture Anchor | Parcus Medical, LLC | MBI | Class II | 2022-05-19 |
| K220468 | BENCOX Mirabo Cup System | Corentec Co., Ltd. | LPH | Class II | 2022-05-18 |
| K220463 | Osteotomy Truss System (OTS) | 4Web Medical, Inc. | HRS | Class II | 2022-05-18 |
| K212527 | Cervical Spine Truss System Plating Solution (CSTS-PS) | 4Web Medical, Inc. | KWQ | Class II | 2022-05-17 |
| K212782 | SternaLock Sternal Closure System | Biomet Microfixation | HRS | Class II | 2022-05-17 |
| K212761 | Biocore9 Acetabular Cup System | Biocore9, LLC | LPH | Class II | 2022-05-17 |
| DEN210044 | CERAMENT G | Bonesupport AB | QRR | Class II | 2022-05-17 |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | MiRus, LLC | OVD | Class II | 2022-05-13 |
| K220757 | Argo Knotless SP Anchor | Conmed Corporation | MBI | Class II | 2022-05-13 |
| K221099 | Arthrex Self-Punching PushLock Suture Anchor | Arthrex, Inc. | MAI | Class II | 2022-05-13 |
| K213785 | SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid | Limacorporate | KWS | Class II | 2022-05-13 |
17,115 clearances in the Orthopedic panel. Data: openFDA.