Panels › Orthopedic › Product code HRS · Class 2
Plate, Fixation, Bone
Regulation 888.3030
62510(k)s in 12 months (1,332 all time)
20recalls in 12 months (288 all time)
277recalls that name a 510(k)
Top companies in HRS
| Company | 510(k)s | Recalls |
|---|---|---|
| Synthes | 104 | 8 |
| Smith & Nephew | 37 | 16 |
| Biomet | 21 | 28 |
| Wrightmedicaltechnologyinc | 45 | 0 |
| Zimmer GmbH | 32 | 12 |
| Wright Medical Technology Inc | 0 | 43 |
| Arthrex, Inc. | 39 | 3 |
| DePuy Orthopaedics, Inc. | 18 | 14 |
| Medartis AG | 32 | 0 |
| TriMed, Inc. | 25 | 6 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2020 | K201959 | DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System DePuy Synthes | HRS |
| Sep 9, 2020 | K201578 | DePuy Synthes Variable Angle Locking Patella Plating System Synthes (USA) Products, LLC | HRS |
| Sep 2, 2020 | K201677 | Arthrex Mesh Plates Arthrex, Inc. | HRS |
| Jul 27, 2020 | K201132 | Arthrex Compression Screws Arthrex, Inc. | HRS |
| Jul 27, 2020 | K200785 | Stratum Reduced Size Foot Plating System Nextremity Solutions, Inc. | HRS |
| Jul 24, 2020 | K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System DePuy Synthes | HRS |
| Jul 22, 2020 | K201527 | EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) Smith & Nephew, Inc. | HRS |
| Jul 22, 2020 | K200513 | DAC Dynamic Active Compression Plate Pioneer Surgical Technology, Inc., Dba Rti Surgical | HRS |
| Jul 15, 2020 | K201149 | CoLink Plating System In2bones USA, LLC | HRS |
| Jul 8, 2020 | K193345 | Arthrex DynaNite Compression Plate Arthrex, Inc. | HRS |
| Jul 6, 2020 | K201235 | Arthrex MaxForce MTP Compression Plates and Screws Arthrex, Inc. | HRS |
| Jun 25, 2020 | K200834 | Lever Action Plate System Mcginley Orthpaedic Innovations, LLC | HRS |
| Jun 5, 2020 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System Stryker GmbH | HRS |
| Jun 1, 2020 | K200538 | Skeletal Dynamics Forearm Plating System Skeletal Dynamics, Inc. | HRS |
| May 22, 2020 | K200246 | JPS JuniOrtho Plating System Orthofix Srl, IT | HRS |
| May 14, 2020 | K200701 | Skeletal Dynamics Midshaft Humerus Plating System Skeletal Dynamics, Inc. | HRS |
| May 14, 2020 | K200367 | Distal Humerus Plating System Skeletal Dynamics, Inc. | HRS |
| May 8, 2020 | K200961 | Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. | HRS |
| Apr 23, 2020 | K200762 | CoLink Cfx Plating System In2bones USA, LLC | HRS |
| Apr 9, 2020 | K191867 | ATLAS Plating System MiRus, LLC | HRS |
| Mar 26, 2020 | K200108 | GEO 1st MTP Joint Arthrodesis Plating System Gramercy Extremity Orthopedics, LLC | HRS |
| Mar 26, 2020 | K193639 | APTUS® Foot 2.8-3.5 System Medartis AG, CH | HRS |
| Mar 26, 2020 | K193633 | APTUS® Ankle Trauma System 2.8/3.5 Medartis AG, CH | HRS |
| Mar 25, 2020 | K193614 | FINE Osteotomy around the knee Bodycad Laboratories, Inc., CA | HRS |
| Mar 23, 2020 | K200043 | Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extr Field Orthopaedics Pty, Ltd., AU | HRS |
| Mar 19, 2020 | K191057 | Park's Pectus System Tdm Co., Ltd., KR | HRS |
| Mar 4, 2020 | K193616 | ARIX Ankle System Jeil Medical Corporation, KR | HRS |
| Feb 27, 2020 | K192619 | Pitkar Locked Plating System S.H.Pitkar Orthotools Pvt. , Ltd., IN | HRS |
| Feb 16, 2020 | K193554 | APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System Medartis AG, CH | HRS |
| Feb 3, 2020 | K190842 | Comus Locking Plate systems Jiangsu Trauhui Medical Instrument Co., Ltd., CN | HRS |
| Jan 24, 2020 | K192984 | APTUS Clavicle System Medartis AG, CH | HRS |
| Jan 20, 2020 | K193222 | Tyber Medical Anatomical Plating System Tyber Medical, LLC | HRS |
| Jan 17, 2020 | K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Af In2bones USA, LLC | HRS |
| Jan 10, 2020 | K193452 | MotoBAND CP Implant System Crossroads Extemity Systems, LLC | HRS |
| Jan 5, 2020 | K192696 | TriMed ASET Foot Plating System TriMed, Inc. | HRS |
| Dec 23, 2019 | K182718 | Mini and Micro Fragments Reconstruction System GMReis Gm Dos Reis Industria E Comerico Ltda., BR | HRS |
| Dec 14, 2019 | K192356 | Airlock Centrolock Osteosynthesis Implant System Novastep, FR | HRS |
| Dec 13, 2019 | K191118 | Avanti Distal Radius and Forearm System Avanti Orthopaedics, Inc. | HRS |
| Dec 9, 2019 | K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System Nebula Surgical Private Limited, IN | HRS |
| Dec 3, 2019 | K192473 | Exsomed Wrist Plating System Exsomed Corporation | HRS |
| Nov 22, 2019 | K192675 | VariAx Foot Stryker GmbH | HRS |
| Nov 21, 2019 | K192592 | Axis Plating System Extremity Medical, LLC | HRS |
| Nov 18, 2019 | K192323 | PolyLock Small Bone Plating System Fusion Orthopedics, LLC | HRS |
| Nov 15, 2019 | K190391 | TDM Plate and Screw Systems Tdm Co., Ltd., KR | HRS |
| Nov 12, 2019 | K191972 | ARIX Wrist System Jeil Medical Corporation, KR | HRS |
| Nov 8, 2019 | K192297 | APTUS Wrist Arthrodesis Plates Medartis AG, CH | HRS |
| Nov 7, 2019 | K192327 | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile Synthes (USA) Products, LLC | HRS |
| Oct 30, 2019 | K192504 | Treace Medical Concepts (TMC) Plating System Treace Medical Concepts, Inc. | HRS |
| Oct 16, 2019 | K190953 | Arthrex Minimally Invasive Ankle Fusion Plate Arthrex, Inc. | HRS |
| Oct 15, 2019 | K191326 | Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module Arthrex, Inc. | HRS |
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