Review Panel
Orthopedic FDA 510(k) Clearances & Devices
- Cleared Devices
- 17,115
- Product Codes (page)
- 28
- Latest Decision
- 2017-08-17
Clearances · page 45 of 172
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K170979 | ARIX Ankle Fibula Hook Plate System | Jeil Medical Corporation | HRS | Class II | 2017-08-17 |
| K171156 | OMNI Anseris Hip Stem | Omnilife Science | LZO | Class II | 2017-08-17 |
| K172165 | Q-Fix Suture Anchor | ArthroCare Corporation | MBI | Class II | 2017-08-17 |
| K170968 | PROPHECY INVISION Pre-operative Navigation System | Wrightmedicaltechnologyinc | HSN | Class II | 2017-08-16 |
| K172175 | CapSure® PS System | Spine Wave, Inc. | NKB | Class II | 2017-08-16 |
| K170910 | Medacta Anatomic Shoulder Prosthesis | Medacta International S.A. | KWS | Class II | 2017-08-16 |
| K170780 | ARIX Foot System (2.3/2.8) | Jeil Medical Corporation | HRS | Class II | 2017-08-14 |
| K161225 | Paonan Armstrong Posterior Spinal Fixation System | Paonan Biotech Co., Ltd. | NKB | Class II | 2017-08-11 |
| K163625 | NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System | Signature Orthopaedics Pty, Ltd. | KWQ | Class II | 2017-08-11 |
| K170624 | TalarLift STS | Fusion Orthopedics, LLC | HWC | Class II | 2017-08-11 |
| K171657 | ShurFit 2C Lumbar Interbody Fusion System | Precision Spine, Inc. | MAX | Class II | 2017-08-11 |
| K172114 | Zimmer Natural Nail System | Zimmer, Inc. | HSB | Class II | 2017-08-10 |
| K163167 | CKS Plus Knee System | Consensus Orthopedics, Inc. | JWH | Class II | 2017-08-09 |
| K170845 | MiniMAX | Medacta International S.A. | LZO | Class II | 2017-08-08 |
| K170888 | Renovis S141 Lumbar Interbody Fusion System | Renovis Surgical Technologies | MAX | Class II | 2017-08-08 |
| K171881 | JAZZ Passer Band | Implanet, S.A. | OWI | Class II | 2017-08-08 |
| K171389 | EVOLUTION Revision CCK System | Microport Orthopedics, Inc. | JWH | Class II | 2017-08-08 |
| K171444 | YUKON OCT Spinal System | K2m, Inc. | NKG | Class II | 2017-08-08 |
| K170038 | FuzeFix Screw System | Fusion Orthopedics, LLC | HWC | Class II | 2017-08-07 |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion Device | 4Web, Inc. | MAX | Class II | 2017-08-07 |
| K170861 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | NKB | Class II | 2017-08-04 |
| K171456 | Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems | Choicespine | NKB | Class II | 2017-08-03 |
| K170919 | The TiBow Expandable Spacer System | Life Spine, Inc. | MAX | Class II | 2017-08-03 |
| K162507 | Arzzt 3.5 / 4.5 Small & Large Fragments System | Truemed Group, LLC | HRS | Class II | 2017-08-03 |
| K171595 | M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System | Medacta International S.A. | OUR | Class II | 2017-08-02 |
| K171758 | M.U.S.T. Combined Set Screws | Medacta International S.A. | NKB | Class II | 2017-08-01 |
| K171075 | Calix-C Cervical Interbody Spacer | X-Spine Systems, Inc. | ODP | Class II | 2017-08-01 |
| K171369 | M.U.S.T. MINI Posterior Cervical Screws System | Medacta International S.A. | NKG | Class II | 2017-08-01 |
| K171054 | Biomet Knee Joint Replacement Prostheses | Biomet, Inc. | JWH | Class II | 2017-07-28 |
| K170313 | ARIX Ankle Distal Tibia System | Jeil Medical Corporation | HRS | Class II | 2017-07-27 |
| K171630 | LumFuse-TP | Precifit Medical, Ltd. | MAX | Class II | 2017-07-25 |
| K170388 | ANCHORMAN Tibial Ligament Fixation Device | Summit Medical , Ltd. | MBI | Class II | 2017-07-25 |
| K163486 | DRACO Locking Bone Screws; DRACO Compression Screws; DRACO MetaFuse L Plates; DRACO MetaFuse BLP Plates; DRACO MetaFuse MTP Plates, Takú Plates, DuoTakú Plates, Open Wedge Plates, Osteoplate Plates, Plantar Plates, Calcaneus Offset Locking Plates | Hnm Total Recon, LLC | KTT | Class II | 2017-07-24 |
| K171724 | Rampart L Lumbar Interbody Fusion Device | Spineology, Inc. | MAX | Class II | 2017-07-24 |
| K171962 | Klassic HD® Hip System | Total Joint Othopedics, Inc. | LPH | Class II | 2017-07-24 |
| K170923 | JAWS(TM) Nitinol Staple System | Paragon 28 | JDR | Class II | 2017-07-24 |
| K171559 | True Spinal Fixation System | Innovative Surgical Designs, Inc. | NKB | Class II | 2017-07-24 |
| K171285 | ARIX Diaphysis System | Jeil Medical Corporation | HRS | Class II | 2017-07-24 |
| K171425 | CONCORDE LIFT | Medos International SARL | MAX | Class II | 2017-07-20 |
| K171439 | EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System | Medos International SARL | KWQ | Class II | 2017-07-20 |
| K170326 | dynaMX Intramedullary Implant | Arthrex, Inc. | HTY | Class II | 2017-07-20 |
| K163589 | SIGN IM Nail | Sign Fracture Care International | HSB | Class II | 2017-07-20 |
| K171838 | TiLock2 Spinal System | Genesys Spine | NKB | Class II | 2017-07-19 |
| K162957 | U2 Femoral Head | United Orthopedic Corporation | LPH | Class II | 2017-07-17 |
| K170613 | Genius Total Knee System | Signature Orthopaedics Pty, Ltd. | JWH | Class II | 2017-07-17 |
| K170710 | True Spinal Fixation System | Innovative Surgical Designs, Inc. | NKB | Class II | 2017-07-14 |
| K171907 | Vitality® Spinal Fixation System | Zimmer Biomet Spine, Inc. | NKB | Class II | 2017-07-14 |
| K162153 | Integra® CAPTURE Screw System & Integra® Ti6® Internal Fixation System | Ascension Orthopedics | HWC | Class II | 2017-07-14 |
| K171413 | HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation System | Globus Medical, Inc. | NQW | Class II | 2017-07-14 |
| K170518 | In2Bones Fracture and Correction System | In2bones USA, LLC | HRS | Class II | 2017-07-14 |
| K170808 | Unity Total Knee System | Corin U.S.A. Limited | JWH | Class II | 2017-07-13 |
| K171018 | Axis Charcot Fixation System, 4.5 to 8.5mm Screw System | Extremity Medical, LLC | HWC | Class II | 2017-07-13 |
| K171749 | Velofix(tm) Interbody Fusion System | U&I Corporation | ODP | Class II | 2017-07-13 |
| K171813 | OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System | L&K BIOMED Co., Ltd. | NKB | Class II | 2017-07-13 |
| K171656 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | MAX | Class II | 2017-07-13 |
| K170676 | HD Lumbar Interbody System | Hd Lifesciences, LLC | MAX | Class II | 2017-07-13 |
| K170550 | Coveris Cervical Cage System | Camber Spine Technologies | ODP | Class II | 2017-07-13 |
| K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | Ht Medical, LLC | ODP | Class II | 2017-07-12 |
| K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages | Eit Emerging Implant Technologies GmbH | MAX | Class II | 2017-07-11 |
| K171448 | Hammertoe Correction System | Life Spine, Inc. | HWC | Class II | 2017-07-07 |
| K171046 | SeaSpine Cambria System | SeaSpine Orthopedics Corporation | ODP | Class II | 2017-07-07 |
| K171031 | CRESCENT Spinal System | Medtronic Sofamor Danek | MAX | Class II | 2017-07-06 |
| K170224 | Spider Cervical Plating System | X-Spine Systems, Inc. | KWQ | Class II | 2017-07-06 |
| K170399 | Endoskeleton TO Interbody Fusion Device (IBD) | Titan Spine, LLC | MAX | Class II | 2017-07-06 |
| K170844 | Gemini-C Hybrid Cervical Interbody System | Osseus Fusion Systems, LLC | ODP | Class II | 2017-07-03 |
| K171284 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | MQV | Class II | 2017-06-30 |
| K170249 | GRAVITY Syndesmosis LP | Wrightmedicaltechnologyinc | HTN | Class II | 2017-06-30 |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Modular Foot System MR Conditional, DePuy Synthes T-Plates MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) MR Conditional, DePuy Synthes Stainless S | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | HRS | Class II | 2017-06-30 |
| K163011 | PHA S1 Spinal System | Phamedica, Inc. | NKB | Class II | 2017-06-29 |
| K161710 | SAGICO IBF SYSTEM ARIA LUMBAR, SAGICO IBF SYSTEM ARION CERVICAL | Spinal Analytics & Geometrical Impant Co, LLC | MAX | Class II | 2017-06-29 |
| K163397 | SMR Hybrid Glenoid System | Lima Corporate S.P.A. | MBF | Class II | 2017-06-29 |
| K170830 | Unison-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | OVE | Class II | 2017-06-28 |
| K171794 | Smith & Nephew 25 Fluid Management System | Smith & Nephew, Inc. | HRX | Class II | 2017-06-27 |
| K171590 | Distal Elbow Plating System | Skeletal Dynamics, LLC | HRS | Class II | 2017-06-27 |
| K162874 | Cannulated Screws Neoortho | Neoortho Produtos Ortopedicos S/A | HWC | Class II | 2017-06-27 |
| K170297 | Tranquil Interbody System | Nexus Spine, LLC | MAX | Class II | 2017-06-27 |
| K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | MAX | Class II | 2017-06-26 |
| K170045 | Swedge Pedicle Screw Fixation System | Spinal Resources, Inc. | NKB | Class II | 2017-06-26 |
| K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | LPH | Class II | 2017-06-26 |
| K170620 | ReBOSSIS85 | Orthorebirth Co., Ltd. | MQV | Class II | 2017-06-23 |
| K171606 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. (Aos) | KTW | Class II | 2017-06-22 |
| K170727 | VariAx 2 Compression Plating System | Stryker GmbH | HRS | Class II | 2017-06-22 |
| K163104 | Terrace Anterior Cervical Plate System | Corelink, LLC | KWQ | Class II | 2017-06-21 |
| K162942 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | LZO | Class II | 2017-06-20 |
| K170418 | Stryker SonicPin System | Stryker Trauma GmbH | HTY | Class II | 2017-06-20 |
| K163494 | Summit Spine Channel Cervical Interbody Fusion System | Summit Spine | ODP | Class II | 2017-06-20 |
| K163593 | Additive Orthopaedics Bunion System | Additive Orthopaedics, LLC | HRS | Class II | 2017-06-20 |
| K170571 | Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw | Tyber Medical, LLC | HWC | Class II | 2017-06-20 |
| K170693 | Phantom Small Bone Intramedullary Nail System | Paragon 28, Inc. | KTW | Class II | 2017-06-19 |
| K163506 | Coalesce (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar Interbody Fusion System | Vertera, Inc. | MAX | Class II | 2017-06-19 |
| K170893 | Materialise Glenoid Positioning System | Materialise NV | KWS | Class II | 2017-06-19 |
| K162641 | Smith & Nephew, Inc. R3 Constrained Liner | Smith & Nephew, Inc. | KWZ | Class II | 2017-06-19 |
| K171538 | Cure Lumbar Plate System | Meditech Spine, LLC | KWQ | Class II | 2017-06-16 |
| K162674 | BioPro Foot Plating Systems | Biopro, Inc. | HRS | Class II | 2017-06-16 |
| K170843 | Alians Fragment Specific | Newclip Technics | HRS | Class II | 2017-06-16 |
| K170806 | ATTUNE Cemented Tibial Base, Fixed Bearing | Depuy(Ireland) | JWH | Class II | 2017-06-15 |
| K170288 | BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell | Microport Orthopedics, Inc. | MBH | Class II | 2017-06-15 |
| K170569 | SeaSpine Shoreline ACS - Anterior Cervical Standalone System | SeaSpine Orthopedics Corporation | OVE | Class II | 2017-06-15 |
| K162719 | iTotal® Hip Replacement System | Conformis, Inc. | LPH | Class II | 2017-06-14 |
| K170457 | EVOS Small Fragment Lower Extremity Plates | Smith & Nephew, Inc. | HRS | Class II | 2017-06-14 |
17,115 clearances in the Orthopedic panel. Data: openFDA.