Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 36
- Latest Decision
- 2020-05-12
Clearances · page 30 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K201136 | Cure Lumbar Plate System | Meditech Spine, LLC | KWQ | Class II | 2020-05-12 |
| K200290 | Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) | SeaSpine Orthopedics Corporation | MQV | Class II | 2020-05-11 |
| K200961 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | 2020-05-08 |
| K200640 | ALTAPORE SHAPE | Baxter Healthcare Corporation | MQV | Class II | 2020-05-08 |
| K193617 | Precice® Screws | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2020-05-08 |
| K193016 | PRECICE Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2020-05-08 |
| K200653 | AMF Revision TT Cones | Lima Corporate S.P.A. | JWH | Class II | 2020-05-07 |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | JWH | Class II | 2020-05-07 |
| K200933 | Syntec Non-Sterile Steinmann Pins System | Syntec Scientific Corporation | JDW | Class II | 2020-05-05 |
| K200846 | Balteum Lumbar Plate System | Huvexel Co. , Ltd. | KWQ | Class II | 2020-05-05 |
| K200914 | Healix Compression Screw System | Nvision Biomedical Technologies, Inc. | HWC | Class II | 2020-05-05 |
| K200259 | Headless Compression Screw System | Osteocentric Extremities, LLC | HWC | Class II | 2020-05-04 |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | Spineart | NKG | Class II | 2020-05-01 |
| DEN180065 | OGmend Implant System | Woven Orthopedic Technologies, LLC | QAC | Class II | 2020-05-01 |
| K200519 | CarboClear® II Pedicle Screw System | CarboFix Orthopedics , Ltd. | NKB | Class II | 2020-04-30 |
| K200523 | Biolign® Roto-Loc Cervical Plate System | Elite Surgical Supplies (Pty), Ltd. | KWQ | Class II | 2020-04-30 |
| K200816 | SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | MAX | Class II | 2020-04-30 |
| K191816 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | LZO | Class II | 2020-04-29 |
| K192097 | Exactech® Equinoxe® Stemless Humeral Components | Exactech, Inc. | PKC | Class II | 2020-04-29 |
| K193394 | Humeral Cup Stability & Humeral Cup 135/145o Stability | Fx Shoulder USA, Inc. | PHX | Class II | 2020-04-29 |
| K200896 | Solstice CCI | Life Spine, Inc. | NKG | Class II | 2020-04-28 |
| K200541 | Hive Stand-alone Anterior Lumbar Interbody System | Hd Lifesciences, LLC | OVD | Class II | 2020-04-28 |
| K200814 | Affixus(R) Natural Nail(R) System Humeral Nail | Zimmer GmbH | HSB | Class II | 2020-04-28 |
| K200863 | Tiger® Occipital-Cervical-Thoracic Spinal Fixation System | Corelink, LLC | NKG | Class II | 2020-04-28 |
| K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | Microport Orthopedics, Inc. | LZO | Class II | 2020-04-25 |
| K193153 | SPIRA-C Integrated Fixation System | Camber Spine Technologies | OVE | Class II | 2020-04-24 |
| K200245 | EXPEDIUM® Spine System; EXPEDIUM VERSE® Spine System | Medos International Sàrl | NKB | Class II | 2020-04-24 |
| K193636 | SeaSpine Reef TH System | SeaSpine Orthopedics Corporation | MAX | Class II | 2020-04-24 |
| K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks | Smith & Nephew, Inc. | JWH | Class II | 2020-04-24 |
| K193305 | DynaClip Bone Staple | MedShape, Inc. | JDR | Class II | 2020-04-23 |
| K200070 | ARx Spinal System | Life Spine, Inc. | NKB | Class II | 2020-04-23 |
| K200666 | Stryker Xia 3 Power Adaptor | Stryker Spine | NKB | Class II | 2020-04-23 |
| K200762 | CoLink Cfx Plating System | In2bones USA, LLC | HRS | Class II | 2020-04-23 |
| K200752 | DB-Orthopedics | Dimensional Bioceramics, LLC | MQV | Class II | 2020-04-22 |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | Astura Medical, LLC | OVD | Class II | 2020-04-21 |
| K192145 | Galileo Vertebral Body Replacement Device | Bright Spine | PLR | Class II | 2020-04-21 |
| K200122 | MOTO PFJ System | Medacta International S.A. | KRR | Class II | 2020-04-20 |
| K191995 | S4 Screw System | Subchondral Solutions, Inc. | HWC | Class II | 2020-04-18 |
| K200338 | ProLift Lateral Fixated | Life Spine, Inc. | OVD | Class II | 2020-04-17 |
| K200709 | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | KWY | Class II | 2020-04-17 |
| K200868 | SI-Restore Sacroiliac Joint Fixation System | Biofusion Medical | OUR | Class II | 2020-04-17 |
| K200729 | HydroCision SpineJet System | Hydrocision, Inc. | HRX | Class II | 2020-04-16 |
| K193549 | SIGMA High Performance (HP) Partial Knee System | Depuy Ireland UC | HRY | Class II | 2020-04-16 |
| K193373 | Comprehensive® Reverse Shoulder | Biomet, Inc. | PHX | Class II | 2020-04-15 |
| K200613 | Tritanium® X TL Expandable Curved Posterior Lumbar Cage | Stryker Corporation | MAX | Class II | 2020-04-15 |
| K191353 | COMET Lumbar Interbody Fusion Cage | Baui Biotech Co., Ltd. | MAX | Class II | 2020-04-14 |
| K191803 | Orthopedic Fixation Pin | Tinavi (Anhui) Medical Technologies Co., Ltd. | JDW | Class II | 2020-04-14 |
| K200112 | Zimmer Hip Joint Replacement | Zimmer GmbH | LZO | Class II | 2020-04-10 |
| K191867 | ATLAS Plating System | MiRus, LLC | HRS | Class II | 2020-04-09 |
| K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System | Orthofix, Inc. | ODP | Class II | 2020-04-09 |
| K191084 | The Optimotion Blue Total Knee System | Optimotion Implants, LLC | MBH | Class II | 2020-04-07 |
| K192013 | VERTICALE® Cervical System | Silony Medical GmbH | NKG | Class II | 2020-04-07 |
| K193494 | Origin Anterior Cervical Plate System | Orthopaedic & Spine Development | KWQ | Class II | 2020-04-06 |
| K200361 | Akros Scruture Anchor LisFranc Repair Kit | Akros Medical | HTN | Class II | 2020-04-06 |
| K200312 | Tryptik Ti | Spineart | ODP | Class II | 2020-04-06 |
| K200696 | FIREBIRD SI Fusion System | Orthofix, Inc. | OUR | Class II | 2020-04-02 |
| K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | MAX | Class II | 2020-04-02 |
| K200552 | EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | MAX | Class II | 2020-04-02 |
| K192646 | SYMPHONY OCT System | Medos International SARL | NKG | Class II | 2020-04-02 |
| K193524 | SI-BONE iFuse Implant System® | SI-BONE, Inc. | OUR | Class II | 2020-03-31 |
| K192818 | Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System | Stryker Corporation | PML | Class II | 2020-03-31 |
| K200281 | The Gecko Spinal System | Ortho Development Corporation | OWI | Class II | 2020-03-31 |
| K193487 | Agilon Strip | Biogennix, LLC | MQV | Class II | 2020-03-30 |
| K193541 | NuVasive Cohere Thoracolumbar Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2020-03-30 |
| K200108 | GEO 1st MTP Joint Arthrodesis Plating System | Gramercy Extremity Orthopedics, LLC | HRS | Class II | 2020-03-26 |
| K193639 | APTUS® Foot 2.8-3.5 System | Medartis AG | HRS | Class II | 2020-03-26 |
| K193633 | APTUS® Ankle Trauma System 2.8/3.5 | Medartis AG | HRS | Class II | 2020-03-26 |
| K193108 | Bonecam Suture Anchor | Valeris Medical, Inc. | MBI | Class II | 2020-03-26 |
| K193614 | FINE Osteotomy around the knee | Bodycad Laboratories, Inc. | HRS | Class II | 2020-03-25 |
| K193615 | NorthStar OCT Spinal System | SeaSpine Orthopedics Corporation | NKG | Class II | 2020-03-25 |
| K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | OVD | Class II | 2020-03-25 |
| K192967 | Medacta Shoulder System | Medacta International S.A. | PHX | Class II | 2020-03-25 |
| K200209 | Persona Personalized Knee System | Zimmer, Inc. | JWH | Class II | 2020-03-24 |
| K200224 | SEA-LINK Anterior Cervical Plate System | Indius Medical Technologies Pvt. , Ltd. | KWQ | Class II | 2020-03-24 |
| K193100 | RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System | OrthoPediatrics Corp. | NKB | Class II | 2020-03-24 |
| K191788 | CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2020-03-23 |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | OVE | Class II | 2020-03-23 |
| K200043 | Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range | Field Orthopaedics Pty, Ltd. | HRS | Class II | 2020-03-23 |
| K193479 | Sternal Cable System | A & E Medical Corporation | JDQ | Class II | 2020-03-23 |
| K193211 | Nano FortiFix® System | Nanovis Spine, LLC | NKB | Class II | 2020-03-20 |
| K191735 | CPT Hip System | Zimmer, Inc. | JDI | Class II | 2020-03-20 |
| K192897 | icotec Cervical Cage | Icotec AG | ODP | Class II | 2020-03-20 |
| K193560 | Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner | Materialise NV | QHE | Class II | 2020-03-20 |
| K193366 | T2 ICF | Stryker GmbH | HWC | Class II | 2020-03-20 |
| K191057 | Park's Pectus System | Tdm Co., Ltd. | HRS | Class II | 2020-03-19 |
| K193061 | G3 40 Radiopaque Bone Cement | G21, S.R.L. | LOD | Class II | 2020-03-19 |
| K193059 | G1 40 Radiopaque Bone Cement | G21, S.R.L. | LOD | Class II | 2020-03-19 |
| K193491 | restor3d Metallic Interference Screw | Restor3D | HWC | Class II | 2020-03-19 |
| K200113 | LINK TrabecuLink Tibial Cones | Waldemar Link GmbH & Co. KG | MBH | Class II | 2020-03-18 |
| K193558 | HEALICOIL Knotless Suture Anchors | Smith & Nephew, Inc. | MAI | Class II | 2020-03-18 |
| K200151 | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill | Zimmer, Inc. | HSX | Class II | 2020-03-17 |
| K200433 | iBalance UKA Tibial Tray Implant | Arthrex, Inc. | HSX | Class II | 2020-03-17 |
| K200097 | Response BandLoc Spinal Fixation | OrthoPediatrics Corp. | OWI | Class II | 2020-03-16 |
| K193418 | SeaSpine Skipjack System | SeaSpine Orthopedics Corporation | MAX | Class II | 2020-03-13 |
| K200075 | 3DMetal Diaphyseal Femoral Cones | Medacta International S.A. | JWH | Class II | 2020-03-13 |
| K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System | Conformis, Inc. | JWH | Class II | 2020-03-13 |
| K200407 | LEGION Inserts with JRNY Lock | Smith & Nephew, Inc. | JWH | Class II | 2020-03-13 |
| K193468 | Tritium Sternal Cable Plate System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | JDQ | Class II | 2020-03-12 |
| K200341 | Arthrex FiberTak Suture Anchor | Arthrex, Inc. | MBI | Class II | 2020-03-12 |
| K192979 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | PBF | Class II | 2020-03-11 |
17,115 clearances in the Orthopedic panel. Data: openFDA.