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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2022 | Wright Medical Technology, Inc. Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System. Terminated |
HRS | K090692 |
| Feb 9, 2022 | Wright Medical Technology, Inc. The DARCO Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The dr Terminated |
HRS | K061808 |
| Jan 4, 2022 | Smith & Nephew, Inc. INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND Open, Classified |
HRS | K073375 |
| Dec 3, 2021 | Wright Medical Technology Inc Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm. Open, Classified |
HRS | K061808 |
| Dec 3, 2021 | Wright Medical Technology Inc Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. Open, Classified |
HRS | K113014 |
| Dec 3, 2021 | Wright Medical Technology, Inc. Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstruction System. Open, Classified |
HRS | K141417 |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202 Terminated |
HRS | K201918 |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102 Terminated |
HRS | K201918 |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201 Terminated |
HRS | K201918 |
| Nov 1, 2021 | Smith & Nephew, Inc. smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101 Terminated |
HRS | K201918 |
| Oct 25, 2021 | Smith & Nephew, Inc. Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile. Open, Classified |
HRS | K162078 |
| Sep 3, 2021 | Flower Orthopedics Corporation Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201 Terminated |
HRS | K123562 |
| Apr 30, 2021 | Wishbone Medical, Inc. WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut.
Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US Terminated |
HRS | K180736 |
| Mar 16, 2021 | K2M, Inc Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine)
Catalog number: 3608-90033 Terminated |
HRS | K111439 |
| Mar 11, 2021 | Arthrex, Inc. Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur. Terminated |
HRS | K032187 |
| Jan 21, 2021 | Biomet, Inc. A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bon Terminated |
HRS | K173767 |
| Aug 24, 2020 | Smith & Nephew, Inc. EVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and small bone fragments. Terminated |
HRS | K140814 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Large, Right, Catalog Number CPF 203 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the cal Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calca Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Medium, Left, Catalog Number CPF 102 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calc Terminated |
HRS | K133930 |
| Aug 12, 2020 | Flower Orthopedics Corporation Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calca Terminated |
HRS | K133930 |
| Jul 21, 2020 | Synthes (USA) Products LLC DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, ra Terminated |
HRS | K011335 |
| Jun 24, 2020 | Arthrex, Inc. Sterile Low Profile Screw, Titanium, 6.7 x 65mm
Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation fo Terminated |
HRS | K141478 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures d Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures d Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures d Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
PROXIMAL HUMERUS PLATE TEMPLATE 234MM
Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and f Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
PROXIMAL HUMERUS PLATE TEMPLATE 140MM
Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and f Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
PROXIMAL HUMERUS PLATE TEMPLATE 90MM,
Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the no Terminated |
HRS | K083843 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures dur Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. T15 LOW PROFILE CORTICAL SCREW
3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal Terminated |
HRS | K083843 K173767 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM
DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | K143697 |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during t Terminated |
HRS | K143697 |
| Dec 16, 2019 | Nextremity Solutions Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation. Terminated |
HRS | K182201 |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
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