# K141527: Depuy Synthes Variable Angle Locking Hand System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes USA
- Decided: Mar 30, 2015 after 294 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K962616 (1996). 97 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System, Synthes (Usa) (2009) Summary page 4.
- K092247: Synthes Locking Hand Plates, Synthes (Usa) (2009) Summary page 4.
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 4.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 4.
- K120689: Synthes 3.5 MM VA-LCP Proximal Tibia Plate System, Synthes (USA) Products, LLC (2012) Summary page 4.
- K110354: 4.5MM VA-LCP Curved Condylar Plate System, Synthes USA (2011) Summary page 4.

## Most influential descendants
- K221150: Advanced Bone Plate (2023), 1 descendant of its own
- K200043: Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range (2020), 1 descendant of its own
- K253906: Xpert Hand (2026), 0 descendants of its own
- K242348: Locking Screw,CoCrMo (2024), 0 descendants of its own
- K242814: Tandry Q-Locking Plate System (2024), 0 descendants of its own

## Indications for use
The DePuy Synthes Variable Angle Locking Hand System is intended for fracture fixation of the hand and other small bones and small bone fragments, in adults and adolescents (12-21) particularly in osteopenic bone. System indications include the following: Open reduction and internal fixation of fractures, mal-unions, and non-unions Following excision of benign bone tumors Replantations and reconstructions Arthrodeses of joints involving small bones Osteotomies, including deformity correction such as rotation, lengthening, shortening Pathological fractures, including impending pathologic fractures

Source page: https://510kreport.com/device/K141527
Methodology: https://510kreport.com/methodology