Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 35
- Latest Decision
- 2020-07-30
Clearances · page 29 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K193660 | OSSIOfiber Compression Screws | OSSIO , Ltd. | HWC | Class II | 2020-07-30 |
| K201786 | Arthrex Mini Hip PushLock | Arthrex, Inc. | MAI | Class II | 2020-07-30 |
| K201648 | Sterispine PS | Safe Orthopaedics | NKB | Class II | 2020-07-30 |
| K201543 | MAGEC® System | Nuvasive Specialized Orthopedics, Inc. | PGN | Class II | 2020-07-30 |
| K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | Biomet UK, Ltd. | LZO | Class II | 2020-07-29 |
| K200518 | Pitkar External Fixation System - Rail Mechanism | S.H.Pitkar Orthotools Pvt. , Ltd. | KTT | Class II | 2020-07-29 |
| K192481 | AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | KWQ | Class II | 2020-07-28 |
| K201132 | Arthrex Compression Screws | Arthrex, Inc. | HRS | Class II | 2020-07-27 |
| K200785 | Stratum Reduced Size Foot Plating System | Nextremity Solutions, Inc. | HRS | Class II | 2020-07-27 |
| K200927 | Transept Cervical Plate System | Neurostructures, Inc. | KWQ | Class II | 2020-07-24 |
| K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System | DePuy Synthes | HRS | Class II | 2020-07-24 |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors | Parcus Medical, LLC | MBI | Class II | 2020-07-23 |
| K200869 | Gamma3 System | Stryker Trauma GmbH | HSB | Class II | 2020-07-22 |
| K201780 | True Tulip System, True M.I.S. System | Innovative Surgical Designs, Inc. | NKB | Class II | 2020-07-22 |
| K201751 | Pedicle Screw System | Black Box Medical, LLC | NKB | Class II | 2020-07-22 |
| K200513 | DAC Dynamic Active Compression Plate | Pioneer Surgical Technology, Inc., Dba Rti Surgical | HRS | Class II | 2020-07-22 |
| K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) | Smith & Nephew, Inc. | HRS | Class II | 2020-07-22 |
| K201349 | Smith+Nephew Arthroscopes | Smith & Nephew | HRX | Class II | 2020-07-20 |
| K201364 | LINK TrabecuLink Femoral Cones | Waldemar Link GmbH & Co. KG | MBH | Class II | 2020-07-17 |
| K201227 | Phantom® Hindfoot TTC/TC Nail System | Paragon 28, Inc. | HSB | Class II | 2020-07-17 |
| K201676 | Barricaid Instrument Tray | Intrinsic Therapeutics, Inc. | QHG | Class II | 2020-07-16 |
| K191698 | TiN Coated Humeral Head | Fx Shoulder USA, Inc. | KWT | Class II | 2020-07-16 |
| K201662 | REDUCT® Headless Compression Screw System | Skeletal Dynamics, Inc. | HWC | Class II | 2020-07-16 |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System | Kyocera Medical Technologies, Inc. | OQG | Class II | 2020-07-16 |
| K191449 | ZCA All-Poly Acetabular Cups | Zimmer, Inc. | JDI | Class II | 2020-07-16 |
| K201614 | TxTiHA IBF System, AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | MAX | Class II | 2020-07-15 |
| K201149 | CoLink Plating System | In2bones USA, LLC | HRS | Class II | 2020-07-15 |
| K191146 | Humelock TiN Coated Glenosphere | Fx Shoulder USA, Inc. | PHX | Class II | 2020-07-15 |
| K201605 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage | Eit Emerging Implant Technologies GmbH | MAX | Class II | 2020-07-15 |
| K192994 | Paragon 28 APEX 3D Total Ankle Replacement System | Paragon 28, Inc. | HSN | Class II | 2020-07-10 |
| K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JWH | Class II | 2020-07-10 |
| K200823 | Zimmer, Inc. Hip Joint Prostheses MR Labeling I | Zimmer, Inc. | JDI | Class II | 2020-07-09 |
| K201556 | Intraosseous Fixation System | Extremity Medical, LLC | HWC | Class II | 2020-07-08 |
| K200656 | Delta Multihole TT Pro Acetabular System | Lima Corporate S.P.A. | LPH | Class II | 2020-07-08 |
| K201542 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | PKC | Class II | 2020-07-08 |
| K193345 | Arthrex DynaNite Compression Plate | Arthrex, Inc. | HRS | Class II | 2020-07-08 |
| K201235 | Arthrex MaxForce MTP Compression Plates and Screws | Arthrex, Inc. | HRS | Class II | 2020-07-06 |
| K193172 | Luna XD Ti Interbody Fusion System | Benvenue Medical, Inc. | MAX | Class II | 2020-07-02 |
| K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System | Stryker GmbH | HSB | Class II | 2020-07-01 |
| K192778 | Kinos Axiom Total Ankle System | Kinos Medical | HSN | Class II | 2020-06-30 |
| K201464 | Altapore MIS | Baxter Healthcare Corporation | MQV | Class II | 2020-06-30 |
| K201507 | Cadence Total Ankle System | Integra LifeSciences Corporation | HSN | Class II | 2020-06-29 |
| K200068 | Arthrex DynaNite K-Wire | Arthrex, Inc. | HTY | Class II | 2020-06-29 |
| K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | HWC | Class II | 2020-06-26 |
| K200226 | RetroFix | Retrofix Screws, LLC | HWC | Class II | 2020-06-26 |
| K200295 | IlluminOss Bone Stabilization System | Illuminoss Medical, Inc. | QAD | Class II | 2020-06-25 |
| K200834 | Lever Action Plate System | Mcginley Orthpaedic Innovations, LLC | HRS | Class II | 2020-06-25 |
| K201414 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | MAI | Class II | 2020-06-25 |
| K192710 | The Simple Locking Intramedullary (Slim) System | Pega Medical, Inc. | HSB | Class II | 2020-06-24 |
| K201430 | InFrame Cannulated Fixation System | Exsomed Corp. | HWC | Class II | 2020-06-20 |
| K193106 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | MAX | Class II | 2020-06-19 |
| K192024 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | LZO | Class II | 2020-06-19 |
| K200283 | Medussa-PL Cage | Medyssey USA, Inc. | MAX | Class II | 2020-06-18 |
| K193513 | SIGNAFUSE Bioactive Bone Graft | Bioventus | MQV | Class II | 2020-06-18 |
| K201347 | DePuy ATTUNE Total Knee System | DePuy Orthopaedics, Inc. | OIY | Class II | 2020-06-18 |
| K201319 | Medline UNITE Jones Fracture Screw System | Medline Industires, Inc. | HWC | Class II | 2020-06-17 |
| K201029 | Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System | Spinal Elements, Inc. | KWQ | Class II | 2020-06-17 |
| K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | Conformis, Inc. | JWH | Class II | 2020-06-16 |
| K193540 | TRUMATCH Personalized Solutions | DePuy Orthopaedics, Inc. | JWH | Class II | 2020-06-16 |
| K190408 | Spinal Fixation System | Shangdong Kangsheng Medical Devices Co., Ltd. | NKB | Class II | 2020-06-16 |
| K201481 | Centurion POCT System | Orthofix, Inc. | NKG | Class II | 2020-06-15 |
| K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | OVE | Class II | 2020-06-15 |
| K200685 | RIGEL 3DR Anterior Cervical Interbody Fusion System | MiRus, LLC | ODP | Class II | 2020-06-11 |
| K200879 | SeaSpine Meridian System, SeaSpine Regatta Lateral System | SeaSpine Orthopedics Corporation | MAX | Class II | 2020-06-10 |
| K192003 | Auxein Nailing System | Auxein Medical Private Limited | JDS | Class II | 2020-06-10 |
| K193075 | Osteo3 ZP Putty | Sirakoss , Ltd. | MQV | Class II | 2020-06-09 |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System | Wrightmedicaltechnologyinc | HSN | Class II | 2020-06-08 |
| K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | HRS | Class II | 2020-06-05 |
| K200615 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | QHE | Class II | 2020-06-05 |
| K200949 | HEALIX ADVANCE Anchor with DYNATAPE Suture | Medos International SARL | MBI | Class II | 2020-06-04 |
| K200883 | CarboClear® Cervical Plate System | CarboFix Orthopedics , Ltd. | KWQ | Class II | 2020-06-04 |
| K200227 | Journey II XR Knee Instrument | Smith & Nephew, Inc. | JWH | Class II | 2020-06-04 |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Encore Medical L.P. | PKC | Class II | 2020-06-03 |
| K200322 | Altus Spine Pedicle Screw System | Altus Partners, LLC | NKB | Class II | 2020-06-02 |
| K200538 | Skeletal Dynamics Forearm Plating System | Skeletal Dynamics, Inc. | HRS | Class II | 2020-06-01 |
| K200920 | Idys ALIF ZP 3DTi | Clariance, Sas | MAX | Class II | 2020-05-29 |
| K200002 | Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device | 4Web, Inc. | OVD | Class II | 2020-05-29 |
| K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | MQP | Class II | 2020-05-29 |
| K200885 | Meridian Anterior Plate System, Regatta Lateral Plate System | SeaSpine Orthopedics Corporation | KWQ | Class II | 2020-05-28 |
| K193233 | Restoration® Modular Hip System | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | LPH | Class II | 2020-05-27 |
| K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | NDN | Class II | 2020-05-27 |
| K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | NKB | Class II | 2020-05-22 |
| K200936 | Invictus CT Spinal Fixation System | Alphatec Spine, Inc. | NKG | Class II | 2020-05-22 |
| K200246 | JPS JuniOrtho Plating System | Orthofix Srl | HRS | Class II | 2020-05-22 |
| K200995 | Insignia Anterior Cervical Plate System | Alphatec Spine, Inc. | KWQ | Class II | 2020-05-21 |
| K200956 | NuVasive Thoracolumbar Plates | Nu Vasive, Incorporated | KWQ | Class II | 2020-05-21 |
| K200969 | NEXXT MATRIXX System | Nexxt Spine, LLC | MAX | Class II | 2020-05-21 |
| K200352 | Axis Spine Technologies ALIF | Axis Spine Technologies, Ltd. | OVD | Class II | 2020-05-20 |
| K201078 | NuVasive® ACP System | Nu Vasive, Incorporated | KWQ | Class II | 2020-05-20 |
| K200303 | Reform Pedicle Screw System | Precision Spine | NKB | Class II | 2020-05-19 |
| K191906 | MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF | MiRus, LLC | MAX | Class II | 2020-05-18 |
| K193122 | Biocore9 Humeral Resurfacing System | Biocore9, LLC | HSD | Class II | 2020-05-15 |
| K200367 | Distal Humerus Plating System | Skeletal Dynamics, Inc. | HRS | Class II | 2020-05-14 |
| K200701 | Skeletal Dynamics Midshaft Humerus Plating System | Skeletal Dynamics, Inc. | HRS | Class II | 2020-05-14 |
| K191826 | KeYi Total Hip System | Beijing Keyi Medical Device Technology Co., Ltd. | LPH | Class II | 2020-05-14 |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite | Howmedica Osteonics Corp. | MBH | Class II | 2020-05-13 |
| K200124 | InCore MPJ System | Nextremity Solutions, Inc. | HWC | Class II | 2020-05-13 |
| K200991 | EVOL Spinal Interbody System | Cutting Edge Spine, LLC | MAX | Class II | 2020-05-13 |
| K193457 | AUDERE Lumbar Spacer System | Met One Technologies | MAX | Class II | 2020-05-12 |
| K192930 | Dymaxeon Spine System | Back 2 Basics Direct, LLC | NKB | Class II | 2020-05-12 |
17,115 clearances in the Orthopedic panel. Data: openFDA.