Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 34
- Latest Decision
- 2021-11-04
Clearances · page 23 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | Biomet Manufacturing Corp | PHX | Class II | 2021-11-04 |
| K212446 | NuVasive Anterior Cervical Plate Systems | Nu Vasive, Incorporated | KWQ | Class II | 2021-11-03 |
| K212823 | DePuy CONDUIT LLIF Angled Inserters | Enztec Limited | MAX | Class II | 2021-11-01 |
| K212831 | MectaLIF Extension | Medacta International S.A. | MAX | Class II | 2021-10-29 |
| K212389 | Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF | Intelivation, LLC | MAX | Class II | 2021-10-29 |
| K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | NDN | Class II | 2021-10-28 |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | PML | Class II | 2021-10-28 |
| K213124 | Tomier Perform Reversed Glenoid Cannulated Glenospheres | Tornier, Inc. | PHX | Class II | 2021-10-26 |
| K210424 | Quantum Anterior Cervical Plate | Nvision Biomedical Technologies, Inc. | KWQ | Class II | 2021-10-22 |
| K213036 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | HWC | Class II | 2021-10-21 |
| K211582 | LOQTEQ Proximal Humerus Plate 3.5 System | Aap Implantate AG | HRS | Class II | 2021-10-18 |
| K212636 | CORUS Spinal System-X | Providence Medical Technology, Inc. | HRX | Class II | 2021-10-15 |
| K212967 | AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | OVD | Class II | 2021-10-15 |
| K212560 | Signature ONE System | Orthosoft Inc (D/B/A Zimmer Cas) | QHE | Class II | 2021-10-12 |
| K212307 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | HSX | Class II | 2021-10-12 |
| K212562 | Idys-C ZP 3DTi | Clariance, SA | OVE | Class II | 2021-10-12 |
| K212552 | Correx Software | Vilex, LLC | KTT | Class II | 2021-10-12 |
| K212520 | ProLift Micro Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2021-10-08 |
| K212156 | ABCcolla Bone Matrix | Acro Biomedical Co., Ltd. | MQV | Class II | 2021-10-08 |
| K212739 | ActiFlip | Parcus Medical, LLC | MBI | Class II | 2021-10-06 |
| K211508 | Steinmann Pins and Kirschner Wires | Stryker GmbH | JDW | Class II | 2021-10-05 |
| K210490 | ChM 4.5mm Cortical screws | Chm Sp. Z O.O. | HWC | Class II | 2021-10-05 |
| K203002 | SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System | Bonebridge AG | HRS | Class II | 2021-10-05 |
| K212135 | Dry DBM- A Putty | Seaspine Corporation | MQV | Class II | 2021-10-04 |
| K212433 | Anthem Fracture System | Globus Medical, Inc. | HRS | Class II | 2021-10-01 |
| K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | Microport Orthopedics, Inc. | LPH | Class II | 2021-10-01 |
| K211221 | Porous Patella and Porous Tibia Baseplate | Smith & Nephew, Inc. | MBH | Class II | 2021-10-01 |
| K211935 | ORIO-Ti Intervertebral Body Fusion Cage System | Spinecraft, LLC | ODP | Class II | 2021-09-30 |
| K212405 | EMERGE Anterior Cervical Plate System | Evolution Spine | KWQ | Class II | 2021-09-30 |
| K211439 | Small Bone Nailing System | Skeletal Dynamics, Inc. | HTY | Class II | 2021-09-30 |
| K211740 | DualX | Amplify Surgical, Inc. | MAX | Class II | 2021-09-29 |
| K210590 | Axis Spine Technologies ALIF | Axis Spine Technologies, Ltd. | OVD | Class II | 2021-09-29 |
| K212129 | Persona® Personalized Knee System | Zimmer Switzerland Manufacturing GmbH | JWH | Class II | 2021-09-28 |
| K211505 | Encore Hip Stem | Signature Orthopaedics Pty, Ltd. | MEH | Class II | 2021-09-24 |
| K211996 | Nexta PEEK Hammertoe Correction System | Nextremity Solutions, Inc. | HWC | Class II | 2021-09-23 |
| K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | Conformis, Inc. | JWH | Class II | 2021-09-23 |
| K212792 | Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | Medynus, Inc. | ODP | Class II | 2021-09-23 |
| K212353 | DB-EZ Bone Void Filler | Dimensional Bioceramics, LLC | MQV | Class II | 2021-09-22 |
| K210263 | Mpres Neck Preserving Stem | Medacta International S.A. | LZO | Class II | 2021-09-22 |
| K211805 | IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2021-09-22 |
| K211689 | KEYSTONE PEEK Cage System | Shanghai Sanyou Medical Co, Ltd. | MAX | Class II | 2021-09-21 |
| K212334 | GEO Extremity and Ankle Plating System | Gramercy Extremity Orthopedics, LLC | HRS | Class II | 2021-09-21 |
| K212692 | Mariner Pedicle Screw System | SeaSpine Orthopedics Corporation | NKB | Class II | 2021-09-21 |
| K211512 | VISIONAIRE UK Patient Matched Cutting Guides | Smith & Nephew, Inc. | HSX | Class II | 2021-09-16 |
| K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating | Waldemar Link GmbH & Co. KG | JWH | Class II | 2021-09-16 |
| K212556 | mi-eye 3 needlescope with cannula, mi-tablet 3 | Trice Medical, Inc. | HRX | Class II | 2021-09-15 |
| K212710 | GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC | PHX | Class II | 2021-09-15 |
| K211474 | Kleiner KG2 System | BAAT Medical Products B.V. | MAX | Class II | 2021-09-14 |
| K201793 | EDEN Peek Cage | Jmt Co., Ltd. | ODP | Class II | 2021-09-13 |
| K212540 | Explorer TO System | SeaSpine Orthopedics Corporation | MAX | Class II | 2021-09-10 |
| K210402 | Curiteva Sacroiliac Joint Fusion System | Curiteva, Inc. | OUR | Class II | 2021-09-09 |
| K211769 | OneLIF Intervertebral Body Replacement System | Novapproach Spine | OVD | Class II | 2021-09-07 |
| K210470 | C-CURVE Interbody Fusion Device | Medicrea International SA | OVE | Class II | 2021-09-03 |
| K210861 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | KWS | Class II | 2021-09-03 |
| K211074 | Univers Revers Modular Glenoid System, Standard Augment Baseplates | Arthrex, Inc. | PHX | Class II | 2021-09-02 |
| K211201 | MagnetOs Easypack Putty | Kuros Biosciences B.V | MQV | Class II | 2021-09-02 |
| K203014 | EndoLIF Delta-Cage and DoubleWedge-Cage | Joimax GmbH | MAX | Class II | 2021-09-01 |
| K212139 | Admiral ACP System | SeaSpine Orthopedics Corporation | KWQ | Class II | 2021-09-01 |
| K211449 | Triton Sacroiliac Joint Fixation System | Choice Spine, LLC | OUR | Class II | 2021-08-31 |
| K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System | Orthofix, Inc. | ODP | Class II | 2021-08-31 |
| K212083 | Tactoset Injectable Bone Substitute | Anika Therapeutics, Inc. | MQV | Class II | 2021-08-31 |
| K210090 | Impulse AM Interbody Fusion System | Degen Medical | MAX | Class II | 2021-08-30 |
| K211903 | Shoreline Threaded TruProfile® Plate | SeaSpine Orthopedics Corporation | KWQ | Class II | 2021-08-30 |
| K211322 | Paratrooper Plantar Plate Repair System | Paragon 28, Inc. | MBI | Class II | 2021-08-30 |
| K212070 | KMTI S141 Lumbar Interbody Fusion System | Kyocera Medical Technologies, Inc. | MAX | Class II | 2021-08-30 |
| DEN200064 | Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System | Canary Medical, Inc. | QPP | Class II | 2021-08-27 |
| K211413 | BEE PLIF Cage | NGMedical GmbH | MAX | Class II | 2021-08-27 |
| K212038 | K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage | K&J Consulting Corporation | ODP | Class II | 2021-08-27 |
| K210122 | Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) | Osteonic Co., Ltd. | MAI | Class II | 2021-08-27 |
| K210790 | Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | PHX | Class II | 2021-08-25 |
| K211609 | ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert | Depuy Ireland UC | JWH | Class II | 2021-08-25 |
| K210792 | Auxein Nailing System | Auxein Medical Private Limited | HWC | Class II | 2021-08-25 |
| K211501 | Advantage-C PEEK Cervical lnterbody Fusion Device | Lntelivation, LLC | ODP | Class II | 2021-08-24 |
| K201157 | Prime BIOFOAM® Multi-Hole Shells | Microport Orthopedics, Inc. | MBL | Class II | 2021-08-24 |
| K210800 | IO Expandable Lumbar Interbody Fusion System | MiRus, LLC | MAX | Class II | 2021-08-20 |
| K211757 | Simplify Disc | Nuvasive, Inc. | QLQ | Class II | 2021-08-20 |
| K210887 | Altus Spine Sochi OCT Spinal System | Altus Partners, LLC | NKG | Class II | 2021-08-20 |
| K203607 | MOSS VRS Spinal System | Biedermann Motech GmbH & Co. KG | NKB | Class II | 2021-08-20 |
| K210533 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | PHX | Class II | 2021-08-20 |
| K203029 | Auxilock Titanium Interference Screw | Auxein Medical Private Limited | HWC | Class II | 2021-08-20 |
| K202705 | Prime and DYNASTY® Additive Manufacturing Shells | Microport Orthopedics, Inc. | OQG | Class II | 2021-08-20 |
| K211895 | BC Reflex Uni Knee System | Bodycad Laboratories, Inc. | HSX | Class II | 2021-08-20 |
| K212297 | Omni Foot and Ankle Plating System | Extremity Medical, LLC | HRS | Class II | 2021-08-20 |
| DEN210013 | OsteoProbe | Active Life Scientific, Inc. | QGQ | Class II | 2021-08-19 |
| K212185 | Golden Isles Pedicle Screw System | Intelivation, LLC | NKB | Class II | 2021-08-19 |
| K211957 | QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | NKG | Class II | 2021-08-18 |
| K211671 | Journey II Mid-Level Tibial Inserts | Smith & Nephew, Inc. | JWH | Class II | 2021-08-17 |
| K212066 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | NKB | Class II | 2021-08-16 |
| K210695 | CPM Medical Consultants Tibial Revision Knee System | Cpm Medical Consultants, LLC | JWH | Class II | 2021-08-16 |
| K211703 | Insignia Hip Stem | Stryker Orthopaedics | MEH | Class II | 2021-08-16 |
| K203817 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | HRS | Class II | 2021-08-13 |
| K211205 | Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | KWQ | Class II | 2021-08-12 |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | In2bones Sas | HSN | Class II | 2021-08-11 |
| K211993 | Z-LINKPC System | Zavation Medical Products, LLC | NKG | Class II | 2021-08-11 |
| K211414 | KHEIRON Spinal Fixation System | S.M.A.I.O | NKB | Class II | 2021-08-10 |
| K211873 | PSX Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2021-08-10 |
| K211435 | PAO Cortical Screw | Medacta International S.A. | HWC | Class II | 2021-08-06 |
| K211783 | TriMed Threaded Intramedullary Nail System | TriMed, Inc. | HWC | Class II | 2021-08-06 |
| K211657 | EMPHASYS Femoral Stems | Depuy Ireland UC | LZO | Class II | 2021-08-05 |
| K211388 | Lateral Spine Truss System (LSTS) Interbody Fusion Device | 4Web Medical, Inc. | MAX | Class II | 2021-08-05 |
17,115 clearances in the Orthopedic panel. Data: openFDA.