Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 30
- Latest Decision
- 2019-04-03
Clearances · page 36 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K190230 | iFuse Implant System® | SI-BONE, Inc. | OUR | Class II | 2019-04-03 |
| K181171 | Zimmer Biomet Ceramic Heads | Zimmer, Inc. | LZO | Class II | 2019-04-02 |
| K183343 | Vantage Total Ankle Flat Cut Talar Components | Exactech, Inc. | HSN | Class II | 2019-04-01 |
| K182221 | Bencox Mirabo Cup Multi Hole | Corentec Co., Ltd. | LPH | Class II | 2019-04-01 |
| K183596 | Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly | Total Joint Orthopedics, Inc. | JWH | Class II | 2019-03-29 |
| DEN180012 | LOADPRO Intraoperative Rod Strain Sensor | Intellirod Spine, Inc. | QFP | Class II | 2019-03-28 |
| K190446 | Responsive Arthroscopy Wedge Push-In Suture Anchors | Responsive Arthroscopy, LLC | MBI | Class II | 2019-03-27 |
| K183628 | Arthrex TensionLoc System | Arthrex, Inc. | HWC | Class II | 2019-03-26 |
| K181778 | MUTARS Proximal Femur Replacement System | Implantcast GmbH | MEH | Class II | 2019-03-25 |
| K190430 | OsteoCentric Bone Plate and Screw System | Osteocentric Trauma | HWC | Class II | 2019-03-22 |
| K182074 | Mineral Collagen Composite Bioactive Moldable | Collagen Matrix, Inc. | MQV | Class II | 2019-03-21 |
| K183582 | MPACT Extension | Medacta International S.A. | LPH | Class II | 2019-03-21 |
| K190418 | NuVasive® VersaTie® System | Nu Vasive, Incorporated | OWI | Class II | 2019-03-21 |
| K190380 | nvc | Nvision Biomedical Technologies, Inc. | ODP | Class II | 2019-03-21 |
| K190425 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | KWQ | Class II | 2019-03-21 |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH | Class II | 2019-03-19 |
| K190333 | Paradigm All-Suture Anchor 1.8mm, White/Black #2 | Conmed Corporation | MBI | Class II | 2019-03-18 |
| K183344 | The Progressive Orthopaedic Company Total Knee System II | The Progressive Orthopaedic Company, LLC | JWH | Class II | 2019-03-18 |
| K190361 | Zavation Spinal System | Zavation Medical Products, LLC | NKB | Class II | 2019-03-18 |
| K183426 | MectaLIF Anterior Stand Alone Extension | Medacta International S.A. | OVD | Class II | 2019-03-15 |
| K190280 | Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly | Total Joint Orthopedics, Inc. | JWH | Class II | 2019-03-15 |
| K183501 | Parcus Twist AP Suture Anchors | Parcus Medical, LLC | MAI | Class II | 2019-03-15 |
| K190283 | PROSTIM Injectable Inductive Graft | Wrightmedicaltechnologyinc | MQV | Class II | 2019-03-14 |
| K180337 | EUROPA Pedicle Screw System | MiRus, LLC | NKB | Class II | 2019-03-14 |
| K182502 | Alteon Acetabular Cup System | Exactech, Inc. | LPH | Class II | 2019-03-13 |
| K183026 | Wright Jones Fracture System | Wrightmedicaltechnologyinc | HWC | Class II | 2019-03-13 |
| K183430 | Modular Spinal Fixation System | Life Spine, Inc. | NKB | Class II | 2019-03-13 |
| K182920 | MiRus Lumbar Interbody Fusion System consisting of CALLISTO PEEK Posterior Lumbar Interbody Fusion (PLIF); HYPERION PEEK Transforaminal Lumbar Interbody Fusion (TLIF); CALPYSO PEEK Lateral Lumbar Interbody Fusion (LLIF); ANTARES PEEK Anterior Lumbar Interbody Fusion (ALIF) | MiRus, LLC | MAX | Class II | 2019-03-13 |
| K183603 | INnate Cannulated Screw System | Exsomed Corporation | HWC | Class II | 2019-03-12 |
| K181610 | ActivOrtho Nitinol Compression Screw System | Activortho, Inc. | HWC | Class II | 2019-03-12 |
| K182771 | ISS-JAZZ Screw System and JAZZ CAP SP | Implanet, S.A. | NKB | Class II | 2019-03-12 |
| K183232 | Double ENDOBUTTON Fixation Device | Smith and Nephew, Inc. | HTN | Class II | 2019-03-12 |
| K183236 | Rotium Bioresorbable Wick | Nanofiber Solutions, LLC | MAI | Class II | 2019-03-11 |
| K190253 | EVOS Small Fragment Upper Extremity Plates Line Additions | Smith & Nephew, Inc. | HRS | Class II | 2019-03-11 |
| K190276 | Provident II Hip Stem | Stelkast, Inc. | LPH | Class II | 2019-03-08 |
| K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | HRX | Class II | 2019-03-08 |
| K183092 | Kuros TLIF Cage | Kuros Biosciences B.V | MAX | Class II | 2019-03-08 |
| K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | Arthrex, Inc. | KWS | Class II | 2019-03-08 |
| K173518 | Spectrum Spine Expandable Cages (SSEC) | Spectrum Spine, LLC | MAX | Class II | 2019-03-07 |
| K190055 | Duo Lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | 2019-03-07 |
| K183397 | ChoiceSpine Stealth Cervical Spacer System | Choicespine, LP | ODP | Class II | 2019-03-06 |
| K183172 | Stryker SternalPlate System | Stryker | HRS | Class II | 2019-03-05 |
| K181843 | MLP Special Locking Bone Plate System | Maxxion Medical, LLC / Baumer SA | HRS | Class II | 2019-03-04 |
| K190193 | SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices | Spineex, Inc. | MAX | Class II | 2019-03-04 |
| K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | Spineart | ODP | Class II | 2019-03-04 |
| K183690 | Tenodesis Screw System | Paragon 28, Inc. | MBI | Class II | 2019-03-01 |
| K183259 | Idys TLIF TiVac | Clariance, Sas | MAX | Class II | 2019-03-01 |
| K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2019-03-01 |
| K180050 | CurvaFix Intramedullary Rodscrew System | Curvafix, Inc. | HWC | Class II | 2019-03-01 |
| K181528 | Austin Miller Large External Fixation System | Austin Miller Trauma, LLC | KTT | Class II | 2019-02-28 |
| K182941 | HEALIX ADVANCE SP PEEK Anchor | Medos International SARL | MBI | Class II | 2019-02-26 |
| K190071 | Perla® Posterior Cervico-Thoracic Fixation System | Spineart | NKG | Class II | 2019-02-25 |
| K182406 | Altus Spine Interbody Fusion System | Altus Partners, LLC | MAX | Class II | 2019-02-22 |
| K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | MQP | Class II | 2019-02-22 |
| K183365 | Libertas Acetabular Hooded Liner | Maxx Orthopedics, Inc. | LZO | Class II | 2019-02-22 |
| K183279 | HEALIX Ti ANCHOR with DYNACORD | Medos International SARL | MBI | Class II | 2019-02-21 |
| K183055 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, LLC | HWC | Class II | 2019-02-19 |
| K181872 | MIS Bunion System | Crossroads Extremity Systems, LLC | HRS | Class II | 2019-02-19 |
| K181362 | TEMA Elbow System | Lima Corporate S.P.A. | JDC | Class II | 2019-02-16 |
| K183049 | Reliance Lumbar IBF System | Reliance Medical Systems, LLC | MAX | Class II | 2019-02-15 |
| K183039 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | Stryker GmbH | KWS | Class II | 2019-02-15 |
| K183225 | Stabil Orthopaedic Solutions Total Knee System | Stabil Orthopaedic Solutions, LLC | JWH | Class II | 2019-02-15 |
| K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups | B-One Ortho, Corp. | LZO | Class II | 2019-02-14 |
| K182677 | DynaNail Mini | MedShape, Inc. | HWC | Class II | 2019-02-14 |
| K183083 | Shoreline Cervical Interbody RT System | SeaSpine Orthopedics Corporation | ODP | Class II | 2019-02-14 |
| K183506 | HEALIX ADVANCE Anchor with DYNACORD Suture | Medos International SARL | MAI | Class II | 2019-02-14 |
| K183317 | AdvantageRib System | Sig Medical Corporation | HRS | Class II | 2019-02-14 |
| K182991 | EPIC Extremity Fusion Plate System | Epic Extremity, LLC | HRS | Class II | 2019-02-13 |
| K182974 | NuVasive Reline System | Nu Vasive, Incorporated | NKB | Class II | 2019-02-13 |
| K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device | Titan Spine, Inc. | ODP | Class II | 2019-02-11 |
| K183073 | SMG Anterior Cervical Plate System | Sapphire Medical Group | KWQ | Class II | 2019-02-11 |
| K181340 | Cemented TSI Hip Stem | Signature Orthopaedics Pty, Ltd. | JDI | Class II | 2019-02-11 |
| K190085 | Journey II Unicompartmental Knee System | Smith & Nephew, Inc. | HSX | Class II | 2019-02-11 |
| K183409 | Athena II Cervical Plate System | Medyssey USA, Inc. | KWQ | Class II | 2019-02-11 |
| K183141 | LINK MP Monoblock Hip Prosthesis | Waldemar Link GmbH & Co. KG | LZO | Class II | 2019-02-08 |
| K183331 | Parcus GFS BTB | Parcus Medical, LLC | MBI | Class II | 2019-02-07 |
| K190035 | Biomet Headless Compression and Twist-Off Screws | Biomet, Inc. | HWC | Class II | 2019-02-07 |
| K182885 | Atlantis Anterior Cervical Plate, Divergence Anterior Cervical Fusion System, Premier Anterior Cervical Plate, Venture Anterior Cervical Plate, Zephir Anterior Cervical Plate System and Zevo Anterior Cervical Plate System | Medtronic Sofamor Danek USA, Inc. | KWQ | Class II | 2019-02-06 |
| K183659 | Omnia Medical Rotary PLIF System | Omnia Medical, LLC | MAX | Class II | 2019-02-06 |
| K183119 | SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments | Globus Medical, Inc. | OUR | Class II | 2019-02-06 |
| K182170 | PRECICE® BONE TRANSPORT System | Nuvasive Specialized Orthopedics, Inc. | HSB | Class II | 2019-02-05 |
| K183447 | EIT Cellular Titanium Lumbar Cage - T/PLIF | Eit Emerging Implant Technologies GmbH | MAX | Class II | 2019-02-04 |
| K190067 | Velofix Interbody Fusion System | U&I Corporation | ODP | Class II | 2019-02-04 |
| K190053 | SECULOK ACP System | U&I Corporation | KWQ | Class II | 2019-02-01 |
| K180626 | Pedimax II - Pedicular Screw Spinal System | Gm Dos Reis Industria E Comerico Ltda. | NKB | Class II | 2019-02-01 |
| K183029 | MOTO Partial Knee System | Medacta International S.A. | HSX | Class II | 2019-01-30 |
| K183136 | Zimmer Segmental System Proximal Femoral Component | Zimmer, Inc. | LZO | Class II | 2019-01-30 |
| K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid | Tornier, Inc. | PHX | Class II | 2019-01-30 |
| K181048 | Neo Cage System TM | Neo Medical SA | MAX | Class II | 2019-01-29 |
| K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component | B-One Ortho, Corp. | JWH | Class II | 2019-01-28 |
| K182477 | Cervical Spacer | Additive Implants, LLC | ODP | Class II | 2019-01-28 |
| K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow | Zimmer, Inc. | JDC | Class II | 2019-01-28 |
| K180822 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System | Wenzel Spine, Inc. | MAX | Class II | 2019-01-28 |
| K182919 | SI-Restore® Sacroiliac Joint Fixation System | Biofusion Medical | OUR | Class II | 2019-01-25 |
| K183228 | HammerToe Compression System | Paragon 28, Inc. | HTY | Class II | 2019-01-25 |
| K183321 | Treace Medical Concepts (TMC) Plating System | Treace Medical Concepts, Inc. | HRS | Class II | 2019-01-25 |
| K182968 | Hoffmann LRF System | Stryker GmbH | KTT | Class II | 2019-01-25 |
| K180230 | NEST Interbody System | Paonan Biotech Co., Ltd. | MAX | Class II | 2019-01-25 |
| K183042 | SMR Lateralized Connectors with screws | Lima Corporate S.P.A. | KWS | Class II | 2019-01-25 |
| K182574 | Freedom Ultra-Congruent CR Tibial Liner | Maxx Orthopedics, Inc. | JWH | Class II | 2019-01-22 |
17,115 clearances in the Orthopedic panel. Data: openFDA.