Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 35
- Latest Decision
- 2019-08-23
Clearances · page 34 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | KWL | Class II | 2019-08-23 |
| K191242 | HEALIX ADVANCE SP BIOCOMPOSITE Anchor | Medos International SARL | MAI | Class II | 2019-08-22 |
| K192021 | NCB Polyaxial Locking Plate System | Zimmer GmbH | HRS | Class II | 2019-08-22 |
| K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | JWH | Class II | 2019-08-22 |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | Wrightmedicaltechnologyinc | HSN | Class II | 2019-08-22 |
| K190044 | VSP Orthopedics System | 3D Systems, Inc. | PBF | Class II | 2019-08-21 |
| K191936 | iNSitu Total Hip System | Thecken Companies, LLC | LPH | Class II | 2019-08-20 |
| K191561 | Exactech Equinoxe Humeral Augmented Trays | Exactech, Inc. | PHX | Class II | 2019-08-20 |
| K191342 | CrossRoads Screw System | Crossroads Extemity Systems, LLC | HWC | Class II | 2019-08-19 |
| K191339 | Zavation eZspand Interbody System | Zavation Medical Products, LLC | MAX | Class II | 2019-08-19 |
| K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic 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 | Titan Spine, Inc. | ODP | Class II | 2019-08-16 |
| K190722 | TriMAX Implant System | Crossroads Extemity Systems, LLC | JDR | Class II | 2019-08-16 |
| K191636 | APTUS Foot System | Medartis AG | JDR | Class II | 2019-08-16 |
| K190991 | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) | MBH | Class II | 2019-08-15 |
| K191621 | ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System | Choice Spine, LLC | ODP | Class II | 2019-08-15 |
| K191553 | NuVaisve® Reline® Cervical System | Nu Vasive, Incorporated | NKG | Class II | 2019-08-14 |
| K191241 | AutoStrut | Orthospin | KTT | Class II | 2019-08-14 |
| K190261 | BOSS Toe Fixation System | Arthrosurface, Inc. | KWD | Class II | 2019-08-14 |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) System | Wrightmedicaltechnologyinc | HWC | Class II | 2019-08-13 |
| K191494 | Facilis Spinal System | Baui Biotech Co., Ltd. | NKB | Class II | 2019-08-12 |
| K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | MAX | Class II | 2019-08-12 |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA) | 4Web, Inc. | OVE | Class II | 2019-08-12 |
| K190025 | EVOL® -SI Joint Fusion System | Cutting Edge Spine, LLC | OUR | Class II | 2019-08-12 |
| K191009 | Arsenal Plating System | Trilliant Surgical | HRS | Class II | 2019-08-12 |
| K190371 | Morpheus-C | Biogennix, LLC | MQV | Class II | 2019-08-09 |
| K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System | In2bones USA, LLC | HRS | Class II | 2019-08-08 |
| K183312 | Conformity Stem | United Orthopedic Corporation | LZO | Class II | 2019-08-08 |
| K191575 | ARx Spinal System | Life Spine, Inc. | NKB | Class II | 2019-08-08 |
| K190562 | iTotal Identity Cruciate Retaining Knee Replacement System | Conformis, Inc. | JWH | Class II | 2019-08-08 |
| K190885 | Elevation Spine Saber-C System | Elevation Spine | OVE | Class II | 2019-08-07 |
| K191274 | BonAlive Granules | Bonalive Biomaterials, Ltd. | MQV | Class II | 2019-08-07 |
| K191423 | Normandy VBR System | Zavation Medical Products, LLC | PLR | Class II | 2019-08-06 |
| K190535 | BiMobile Dual Mobility System - E-Dur Inserts | Waldemar Link GmbH & Co. KG | LZO | Class II | 2019-08-06 |
| K191835 | CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments | Globus Medical, Inc. | NKB | Class II | 2019-08-06 |
| K191781 | Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System | Zimmer GmbH | LZO | Class II | 2019-08-06 |
| K191565 | Endoskeleton TCS Interbody Fusion Device | Titan Spine, Inc. | OVE | Class II | 2019-08-06 |
| K190992 | OrthoPediatrics PediFoot Deformity Corrections System | OrthoPediatrics Corp. | HRS | Class II | 2019-08-06 |
| K183091 | Elaris Pedicle Screw System | Spinewelding AG | NKB | Class II | 2019-08-02 |
| K191217 | JAZZ PF | Implanet, S.A. | OWI | Class II | 2019-08-02 |
| K191192 | SurgTech GENOLL Total Knee System | Surgtech, Inc. | JWH | Class II | 2019-08-01 |
| K182818 | LOQTEQ VA Calcaneus Plate 3.5 | Aap Implantate AG | HRS | Class II | 2019-08-01 |
| K191764 | Inion BioRestore | Inion OY | MQV | Class II | 2019-07-31 |
| K190291 | Addivation Medical Cervical Interbody System | Addivation Medical, LLC | ODP | Class II | 2019-07-30 |
| K191289 | Bone Screw Line Addition | Vilex IN Tennessee, Inc. | HWC | Class II | 2019-07-29 |
| K191535 | CoLink® Mini Plating System | In2bones USA, LLC | HRS | Class II | 2019-07-29 |
| K183129 | Medtronic Total Hip Arthroplasty System | Medtronic Advanced Energy | LPH | Class II | 2019-07-26 |
| K191817 | ActivOrtho Continuous Compression Screw System | Activortho, Inc. | HWC | Class II | 2019-07-26 |
| K183194 | Arthrex Eclipse Shoulder Prosthesis System | Arthrex, Inc. | QHQ | Class II | 2019-07-26 |
| K183249 | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage | Stryker Spine | MAX | Class II | 2019-07-25 |
| K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer | Osteoremedies, LLC | JWH | Class II | 2019-07-25 |
| K191211 | JOURNEY II Unicompartmental Knee System | Smith & Nephew, Inc. | HSX | Class II | 2019-07-25 |
| K190774 | RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant | Medos International SARL | MBI | Class II | 2019-07-25 |
| K190471 | 4CIS® Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. | NKB | Class II | 2019-07-24 |
| K190926 | Hammertoe Truss System (HTS) | 4Web, Inc. | HTY | Class II | 2019-07-23 |
| K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional | Synthes (USA) Products, LLC | HRS | Class II | 2019-07-23 |
| K190488 | ProLift Expandable System | Life Spine, Inc. | MAX | Class II | 2019-07-23 |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Corin USA | LZO | Class II | 2019-07-22 |
| K191374 | Revival Modular Hip Stem | Corin U.S.A. Limited | LZO | Class II | 2019-07-22 |
| K191648 | Mariner MIS Pedicle Screw System; SeaSpine Navigation System | SeaSpine Orthopedics Corporation | NKB | Class II | 2019-07-19 |
| K191757 | EUROPA Pedicle Screw System | MiRus, LLC | NKB | Class II | 2019-07-19 |
| K190895 | MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System | Medos International SARL | NKG | Class II | 2019-07-18 |
| K191755 | SPAR-K Instruments (for use with Gemini SL Total Knee System) | Waldemar Link GmbH & Co. KG | JWH | Class II | 2019-07-18 |
| K190680 | FAVO S-TLIF | Silony Medical GmbH | MAX | Class II | 2019-07-18 |
| K191598 | AOS ES Retrograde Femoral Nail | Advanced Orthopaedic Solutions, Inc. | HSB | Class II | 2019-07-18 |
| K183532 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | LZO | Class II | 2019-07-18 |
| K191053 | Xtreme-Loop | Xiros, Ltd. | MBI | Class II | 2019-07-17 |
| K191345 | Pegasus System | A.M. Surgical, Inc. | HRX | Class II | 2019-07-17 |
| K191711 | ORTHOLOC SPS Shoulder Plating System | Tornier, Inc. | HRS | Class II | 2019-07-17 |
| K191325 | EMPOWR Partial Knee | Encore Medical L.P. | HSX | Class II | 2019-07-16 |
| K190123 | MicroPort CoCr Femoral Heads | Microport Orthopedics, Inc. | LPH | Class II | 2019-07-15 |
| K182158 | UNiD Patient-matched PLIF cage | Medicrea International SA | MAX | Class II | 2019-07-15 |
| K191259 | Stryker CrossFlow Integrated Arthroscopy Pump | Stryker Corp. | HRX | Class II | 2019-07-12 |
| K191594 | Nuvis Battery Arthroscope | Integrated Endoscopy, Inc. | HRX | Class II | 2019-07-11 |
| K191579 | Voyant System | Viseon, Inc. | HRX | Class II | 2019-07-11 |
| K191045 | Salvo Spine System | Spine Wave, Inc. | NKB | Class II | 2019-07-10 |
| K183243 | Velofix TLIF Cage | U&I Corporation | MAX | Class II | 2019-07-10 |
| K191408 | Nexxt Matrixx System | Nexxt Spine, LLC | MAX | Class II | 2019-07-10 |
| K190286 | Materialise Glenoid Positioning System | Materialise NV | KWS | Class II | 2019-07-08 |
| K190324 | OrthoPediatrics Cannulated Screw System | OrthoPediatrics Corp. | HWC | Class II | 2019-07-05 |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | MAX | Class II | 2019-07-05 |
| K191238 | Zimmer Guide Wire Devices | Zimmer, Inc. | HSB | Class II | 2019-07-05 |
| K191367 | Harrier-SA Lumbar Interbody System | Choice Spine, LLC | MAX | Class II | 2019-07-05 |
| K190915 | OsteoFab Suture Anchors | Oxford Performance Materials, Inc. | MBI | Class II | 2019-07-03 |
| K191169 | NuVasive® Camber Laminoplasty System | Nu Vasive, Incorporated | NQW | Class II | 2019-07-03 |
| K191204 | Infinity Fixation System | Conmed Corporation | MBI | Class II | 2019-07-03 |
| K190959 | ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2019-07-03 |
| K190166 | TriMed Nitinol Staple System | TriMed, Inc. | JDR | Class II | 2019-07-01 |
| K183064 | TxTi IBF System | Innovasis, Inc. | MAX | Class II | 2019-06-28 |
| K191483 | HEALIX ADVANCE Anchor with DYNA+TAPE Sutures | Medos International SARL | MBI | Class II | 2019-06-28 |
| K190516 | MicroLink All-Suture Button Fixation System (Radiolucent) | Conmed Corporation | HTN | Class II | 2019-06-28 |
| K190582 | MicroLink All-Suture Button Fixation System (Radiopaque) | Conmed Corporation | HTN | Class II | 2019-06-28 |
| K182704 | WishBone Guided Growth System | Wishbone Medical | OBT | Class II | 2019-06-25 |
| K190754 | Orthoss(R) | Geistlich Pharma AG | MQV | Class II | 2019-06-23 |
| K182139 | AXTi Titanium Stand-Alone ALIF System | Innovasis, Inc. | OVD | Class II | 2019-06-21 |
| K190750 | DePuy Synthes Plates and Screws Portfolio | DePuy Synthes | HRS | Class II | 2019-06-21 |
| K190360 | LineSider Spinal System | Integrity Implants, Inc. | NKB | Class II | 2019-06-21 |
| K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | NKB | Class II | 2019-06-20 |
| K182285 | PK High Tibial Osteotomy Correction System | Paonan Biotech Co., Ltd. | KTW | Class II | 2019-06-20 |
| K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System | Renovis Surgical Technologies | JWH | Class II | 2019-06-20 |
| K190762 | The JASPER Spinal Fixation System II | Gbs Commonwealth Co., Ltd. | NKB | Class II | 2019-06-19 |
17,115 clearances in the Orthopedic panel. Data: openFDA.