Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 34
- Latest Decision
- 2021-08-04
Clearances · page 24 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K211049 | Tigon Medical Button System | Tigon Medical | MBI | Class II | 2021-08-04 |
| K211502 | Alpha Vent PEEK Suture Anchor | Stryker Endoscopy | MBI | Class II | 2021-08-04 |
| K211553 | Tecomet Global Unite Short Stem Instrumentation | Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. | PHX | Class II | 2021-08-04 |
| K211290 | Cannulated Fasteners and Nuts | OsteoCentric Technologies | HWC | Class II | 2021-08-03 |
| K210521 | DEXA-C Cervical Interbody System | Aurora Spine, Inc. | ODP | Class II | 2021-08-02 |
| K203408 | Summit Patella Plating System | Endeavor Orthopaedics, LLC | HRS | Class II | 2021-07-30 |
| K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System | Orthofix, Inc. | NKG | Class II | 2021-07-30 |
| K210953 | SMART Taylor Spatial Frame | Smith & Nephew, Inc. | KTT | Class II | 2021-07-29 |
| K211664 | GMK Sphere Revision | Medacta International S.A. | JWH | Class II | 2021-07-29 |
| K211991 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | PHX | Class II | 2021-07-28 |
| K201657 | Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads | Corin, Ltd. | LZO | Class II | 2021-07-28 |
| K211677 | ELEOS Limb Salvage System | Onkos Surgical | KRO | Class II | 2021-07-28 |
| K211646 | FINE Osteotomy | Bodycad Laboratories, Inc. | HRS | Class II | 2021-07-28 |
| K210016 | Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System | Integra LifeSciences Corporation | HRS | Class II | 2021-07-27 |
| K211932 | Fixxsure Anterior Lumbar Plate and Screw System | Oak Tree Engineering, LLC | KWQ | Class II | 2021-07-27 |
| K212030 | Flex-Thread Distal Fibula lntramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | HSB | Class II | 2021-07-23 |
| K211602 | Klassic Knee System | Total Joint Orthopedics, Inc. | JWH | Class II | 2021-07-23 |
| K210382 | Blustone Synergy Diamond SA Cervical System | Blustone Synergy, LLC | OVE | Class II | 2021-07-23 |
| K210159 | IntraLock System | Fusion Orthopedics, LLC | HWC | Class II | 2021-07-23 |
| K211944 | Medline UNITE® Digital Fusion Screw System | Medline Industries, Inc. | HWC | Class II | 2021-07-22 |
| K203175 | POLARSTEM Cemented Femoral Stem | Smith & Nephew, Inc. | LZO | Class II | 2021-07-22 |
| K203694 | DELTA XTEND Reverse Shoulder System | Depuy Ireland UC | PHX | Class II | 2021-07-22 |
| K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | NKB | Class II | 2021-07-21 |
| K210963 | ENNOVATE Spinal System | Aesculap Implant Systems, LLC | NKB | Class II | 2021-07-19 |
| K211548 | POLARSTEM Calcar Reamer Guide | Smith & Nephew, Inc. | LZO | Class II | 2021-07-19 |
| K201147 | Elos® Intramedullary Nailing System | Intrauma S.P.A | HSB | Class II | 2021-07-19 |
| K211111 | SureMAX-SA Cervical Standalone System | Additive Implants, Inc. | OVE | Class II | 2021-07-16 |
| K203108 | Ignite Stemless Anatomic Shoulder System | Ignite Orthopedics, LLC | PKC | Class II | 2021-07-16 |
| K211592 | Avanti Orthopaedics Ulnar Shortening System | Avanti Orthopaedics, Inc. | HRS | Class II | 2021-07-16 |
| K210750 | Acumed Clavicle Hook Plating System | Acumed, LLC | HRS | Class II | 2021-07-15 |
| K203023 | Pisces Spinal System | Ortho Development Corporation | NKB | Class II | 2021-07-14 |
| K211866 | Bencox THR System | Corentec Co., Ltd. | LPH | Class II | 2021-07-14 |
| K201733 | Provident II Hip Stems | Globus Medical, Inc. | LPH | Class II | 2021-07-14 |
| K211938 | Physica LMC Knee System | Limacorporate | JWH | Class II | 2021-07-13 |
| K211113 | Zavation Spinal System | Zavation Medical Products, LLC | NKB | Class II | 2021-07-12 |
| K210717 | Bone Screws dia. 5,0 mm | Lima Corporate S.P.A. | PHX | Class II | 2021-07-12 |
| DEN200039 | InSpace Subacromial Tissue Spacer System | Ortho-Space , Ltd. | QPQ | Class II | 2021-07-12 |
| K200575 | TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM | Truemed Group, LLC | HRS | Class II | 2021-07-09 |
| K210607 | PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro | Heraeus Medical GmbH | LOD | Class II | 2021-07-09 |
| K211002 | Grappler Suture Anchor System | Paragon 28, Inc. | MBI | Class II | 2021-07-07 |
| K210497 | SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene, SeaSpine Vu ePOD System, SeaSpine Vu aPOD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System | SeaSpine Orthopedics Corporation | MAX | Class II | 2021-07-07 |
| K203003 | Pantheon IBFD | Pantheon Spinal | MAX | Class II | 2021-07-07 |
| K210542 | aprevo Transforaminal IBF | Carlsmed, Inc. | MAX | Class II | 2021-06-30 |
| K211768 | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE | Waldemar Link GmbH & Co. KG | KRO | Class II | 2021-06-30 |
| K210044 | Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System | Spinal Elements, Inc. | MAX | Class II | 2021-06-30 |
| K210837 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | HRS | Class II | 2021-06-29 |
| K210869 | Phantom Hindfoot TTC/TC Nail System | Paragon 28, Inc. | HSB | Class II | 2021-06-28 |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | Stryker Instruments | NDN | Class II | 2021-06-25 |
| K211306 | LABYRINTH | Zavation Medical Products, LLC | MAX | Class II | 2021-06-24 |
| K211297 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | HRX | Class II | 2021-06-24 |
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Arthrosurface, Inc. | PHX | Class II | 2021-06-24 |
| K211695 | Valkyrie Thoracic Fixation System | Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices | HRS | Class II | 2021-06-23 |
| K211606 | Mariner Deformity System | SeaSpine Orthopedics Corporation | NKB | Class II | 2021-06-23 |
| K211408 | CervAlign® Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | KWQ | Class II | 2021-06-23 |
| K210899 | LINK Embrace Shoulder System- Anatomical Configuration | Waldemar Link GmbH & Co. KG | KWT | Class II | 2021-06-21 |
| K201737 | Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co, Ltd. | NKB | Class II | 2021-06-21 |
| K201314 | Restor3d Utility Wedge | Restor3D, Inc. | PLF | Class II | 2021-06-17 |
| K202806 | Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) | Osteonic Co., Ltd. | MAI | Class II | 2021-06-17 |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers | Camber Spine Technologies, LLC | MAX | Class II | 2021-06-15 |
| K203779 | Symmetric Total Knee System | Signal Medical Corporation | MBH | Class II | 2021-06-10 |
| K203815 | ELEOS Limb Salvage System with BioGrip | Onkos Surgical | JDI | Class II | 2021-06-09 |
| K210050 | Augmented VaultLock Glenoid | Arthrex, Inc. | KWS | Class II | 2021-06-07 |
| K203802 | X-Pac Expandable Lumbar Cage System | Expanding Innovations, Inc. | MAX | Class II | 2021-06-07 |
| K202663 | Suture Wing | Osteonic Co., Ltd. | MBI | Class II | 2021-06-07 |
| K211303 | Avon Patello-femoral Joint Prosthesis | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | KRR | Class II | 2021-06-04 |
| K202763 | Fix2Lock (PEEK Self Punching) | Osteonic Co., Ltd. | MBI | Class II | 2021-06-04 |
| K211323 | ASTRA Spine System | Spinecraft, LLC | NKB | Class II | 2021-06-03 |
| K210583 | SeaSpine WaveForm A Interbody System | SeaSpine Orthopedics Corporation | MAX | Class II | 2021-06-02 |
| K211051 | DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) | DePuy Synthes | HRS | Class II | 2021-06-02 |
| K210994 | Arthrex Beveled FT Screws | Arthrex, Inc. | HWC | Class II | 2021-06-01 |
| K200607 | LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters | Waldemar Link GmbH & Co. KG | LPH | Class II | 2021-05-28 |
| K211261 | Axis Charcot Fixation System | Extremity Medical, LLC | HWC | Class II | 2021-05-28 |
| K211057 | LigaPASS® Spinal System, CD Horizon Spinal System | Medtronic, Inc. | OWI | Class II | 2021-05-27 |
| K211258 | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2021-05-26 |
| K211292 | Fassier-Duval Telescopic IM System | Pega Medical, Inc. | HSB | Class II | 2021-05-26 |
| K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | Synthes (USA) Products, LLC | KTT | Class II | 2021-05-25 |
| K210214 | NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2021-05-24 |
| K210425 | Catalyft PL Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | MAX | Class II | 2021-05-24 |
| K211246 | LEGION CR Porous Plus HA Femoral Components | Smith & Nephew, Inc. | MBH | Class II | 2021-05-24 |
| K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | MEH | Class II | 2021-05-20 |
| K202716 | Ignite Anatomic Shoulder System | Ignite Orthopedics, LLC | MBF | Class II | 2021-05-20 |
| K210306 | GII Spinal Fixation System | Coligne AG | NKB | Class II | 2021-05-19 |
| K210829 | Persona Revision Knee System Femoral Metaphyseal Cones | Zimmer, Inc. | JWH | Class II | 2021-05-18 |
| K210816 | True Tulip, True M.I.S. | Innovative Surgical Designs, Inc. | NKB | Class II | 2021-05-18 |
| K202458 | BonOs Inject, Pedicle screw kits, Cement pusher | Osartis GmbH | LOD | Class II | 2021-05-18 |
| K210874 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | NKB | Class II | 2021-05-13 |
| K211004 | GMK Spherika Femurs and Fixed Tibial Trays Plus | Medacta International S.A. | JWH | Class II | 2021-05-13 |
| K202924 | LinkSymphoKnee System | Waldemar Link GmbH & Co. KG | JWH | Class II | 2021-05-13 |
| K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) | Conformis, Inc. | JWH | Class II | 2021-05-12 |
| K210439 | NuVasive MOD-EX XLIF Interbody System | Nu Vasive, Incorporated | MAX | Class II | 2021-05-12 |
| K203228 | DART-FIRE EDGE Cannulated Screw System | Wright Medical | HWC | Class II | 2021-05-11 |
| K203311 | ChoiceSpine Blackhawk Ti Cervical Spacer System | Choice Spine, LLC | OVE | Class II | 2021-05-10 |
| K203832 | FuseForce Flex Dynamic Compression System | Wright Medical | JDR | Class II | 2021-05-07 |
| K202971 | DRPx Locking Distal Radius Plate System | Orthopaedic Implant Company | HRS | Class II | 2021-05-06 |
| K210191 | Identity Imprint Knee Replacement System | Conformis, Inc. | JWH | Class II | 2021-05-06 |
| K210728 | CONDUIT Instruments | Medos International SARL | MAX | Class II | 2021-05-06 |
| K211112 | OIC External Fixation System | Orthopaedic Implant Company | KTT | Class II | 2021-05-05 |
| K200765 | Genius / Genuin Total Knee System | Biorad Medisys Pvt, Ltd. | JWH | Class II | 2021-05-05 |
| K203698 | CoLink Sfx Implant System | In2bones USA, LLC | HTY | Class II | 2021-05-04 |
| K203218 | CaP Spheres Pellet Pack | Zimmer Biomet Spine, Inc. | MQV | Class II | 2021-05-04 |
17,115 clearances in the Orthopedic panel. Data: openFDA.