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) |
|---|---|---|---|
| Oct 30, 2026 | Smith & Nephew, Inc. EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM
REF72463106 Open, Classified |
HRS | K170457 K210837 +1 |
| Oct 1, 2026 | Wright Medical Technology, Inc. CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System Open, Classified |
HRS | K133715 |
| Jun 23, 2026 | Acumed LLC Acumed Hexalob Screw various sizes:
REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw;
3070-27009 2.7mm x 9mm NL Hexalobe Screw;
3070-27010 2.7mm x 10mm NL Hexalobe Screw;
3070-27011 2.7mm x 11m Open, Classified |
HRS | K251132 K251296 |
| Mar 20, 2026 | I.T.S. GmbH Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions and corresponding article numbers.
1. Anterior Column Plate; Article Numbers: 21218-16, 21219-16.
Open, Classified |
HRS | K210935 |
| Mar 20, 2026 | I.T.S. GmbH HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers.
1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, Open, Classified |
HRS | K142418 |
| Mar 20, 2026 | I.T.S. GmbH FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers.
1. FLS - Foot Locking Plates System, Cancellous Stabilization Open, Classified |
HRS | K131722 |
| Mar 20, 2026 | I.T.S. GmbH I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers.
1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Open, Classified |
HRS | K130008 |
| Mar 20, 2026 | I.T.S. GmbH I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers.
1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9 Open, Classified |
HRS | K093868 |
| Mar 20, 2026 | I.T.S. GmbH Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers.
1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16- Open, Classified |
HRS | K080184 |
| Mar 20, 2026 | I.T.S. GmbH I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers.
1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602- Open, Classified |
HRS | K063672 |
| Mar 20, 2026 | I.T.S. GmbH Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers.
1. Fixation Screw; Article Number: 70312.
2. Spike short; Article Number: 70314. Open, Classified |
HRS | K063166 |
| Mar 20, 2026 | I.T.S. GmbH I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers.
1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9.
2. Forearm Plate, Straight; Open, Classified |
HRS | K060156 |
| Mar 20, 2026 | I.T.S. GmbH Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers.
1. Olecranon Hook Plate; Article Numbers: 21112-7, 21114-5, 21113-9.
2. Olecranon Plate; Article Open, Classified |
HRS | K052368 |
| Mar 20, 2026 | I.T.S. GmbH Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers.
1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 2131 Open, Classified |
HRS | K052011 |
| Mar 20, 2026 | I.T.S. GmbH FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60. Open, Classified |
HRS | K051642 |
| Mar 20, 2026 | I.T.S. GmbH Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136 Open, Classified |
HRS | K051412 |
| Mar 20, 2026 | I.T.S. GmbH Claviculaplate with Angular Stability, with the below descriptions and associated article numbers.
1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10.
2. Clavicle Pla Open, Classified |
HRS | K050852 |
| Mar 20, 2026 | I.T.S. GmbH Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5, 21034-3, 21034-5, 21 Open, Classified |
HRS | K033756 |
| Jan 20, 2026 | Tyber Medical Brand Name: VOLT" Wrist Treatment System
Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm
Model/Catalog Number: 02.426.691S
Product Description: 2 Column Distal Radius Plate Open, Classified |
HRS | K232652 |
| Jan 20, 2026 | Tyber Medical Brand Name: VOLT" Wrist Treatment System
Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm
Model/Catalog Number: 02.426.681S
Product Description: 2 Column Distal Radius Plate Open, Classified |
HRS | K232652 |
| Oct 21, 2025 | CPM Medical Consultants, LLC. Fuse ULTRA Foot Plating System Instructions for Use.
Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, OS200125L, OS200135, OS200324, OS200325, OS200326, OS328026, OS32 Open, Classified |
HRS | K141784 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right
Intended Fixation of fractures of the distal tibia
Model/Catalog Number: 770715162 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H LT-Medial Tibia Plate, 16-Hole, Left
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770715161 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770715122 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left
Intended forFixation of fractures of the distal tibia
Model/Catalog Number: 770715121 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right
Intended Fixation of fractures of the distal tibia.
Model/Catalog Number: 770715102 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left.
Intended Fixation of fractures of the distal tibia
Model/Catalog Number: 770715101 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- MEDIAL TIBIA PLATE 6H RT-Medial Tibia Plate, 6-Hole, Right
Model/Catalog Number: 770715062
Intended for Fixation of fractures of the distal tibia Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770715061 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right.
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708122
Product Description: Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left.
Inended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708121 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 10H RT- Anatomic Lateral Fibula Plate, 10-Hole, Right.
Intended forFixation of fractures of the distal tibia
Model/Catalog Number: 770708102
Product Description: Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left.
Intended Fixation of fractures of the distal tibia
Model/Catalog Number: 770708101 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right
Indicated for use in Fixation of fractures of the distal tibia
Model/Catalog Number: 77070802 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left
Intended to bridge or otherwise stabilize bone fragments to facilitate healing.
Model/Catalog Number: 770708081 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right
Model/Catalog Number: 770708062 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708061 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 4H RT: Anatomic Lateral Fibula Plate, 4-hole, Right
Model/Catalog Number: 770708042 Open, Classified |
HRS | K232652 |
| Feb 21, 2025 | Tyber Medical A.L.P.S. mvX - ANATOMIC LAT FIB PLATE 4H LT: Anatomic Lateral Fibula Plate, 4-hole, Left
Intended for Fixation of fractures of the distal tibia
Model/Catalog Number: 770708041 Open, Classified |
HRS | K232652 |
| Aug 23, 2024 | Treace Medical Concepts, Inc. Nanoplasty 3D Bunion Correction System Implant, Model Number: SK57. System contains the 01-00066 1st Metatarsal Plate as a component. Open, Classified |
HRS | K240173 |
| Mar 1, 2024 | Synthes (USA) Products LLC VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments.
Part Number: 02.112.621S Open, Classified |
HRS | K201321 |
| Feb 29, 2024 | Acumed LLC Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standar Open, Classified |
HRS | None listed |
| Jan 31, 2024 | TriMed Inc. Volar Bearing Plate.
REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W.
In Open, Classified |
HRS | K222637 |
| Jul 28, 2023 | Zimmer, Inc. Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminu Open, Classified |
HRS | K141734 |
| Apr 26, 2023 | Wright Medical Technology, Inc. stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation Open, Classified |
HRS | K120359 |
| Apr 26, 2023 | Wright Medical Technology, Inc. stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation Open, Classified |
HRS | K120359 |
| Apr 17, 2023 | GRAMERCY EXTREMITY ORTHOPEDICS GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System Open, Classified |
HRS | K200108 |
| Feb 24, 2023 | Wright Medical Technology, Inc. ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device Open, Classified |
HRS | K113014 |
| Feb 24, 2023 | Wright Medical Technology, Inc. ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device Open, Classified |
HRS | K113014 |
| May 18, 2022 | Paragon 28, Inc. Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm Open, Classified |
HRS | None listed |
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