# K150099: Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (USA) Products, LLC
- Decided: Mar 23, 2015 after 62 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: 11 generations back to K962616 (1996). 86 ancestors in all.
14 later devices descend from it; 6 cite it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 4.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 4.
- K100776: Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System, Synthes (Usa) (2010) Summary page 4.
- K112583: Synthes Cortical Screws, Synthes (USA) Products, LLC (2011) Summary page 4.

## Most influential descendants
- K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System (2024), 4 descendants of its own
- K212348: ALPHALOK™ Plating System (2022), 3 descendants of its own
- K221558: ALPHALOK Plating System (2022), 2 descendants of its own
- K190391: TDM Plate and Screw Systems (2019), 1 descendant of its own
- K253906: Xpert Hand (2026), 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: o Open reduction and internal fixation of fractures, mal-unions, and non-unions o Following excision of benign bone tumors o Replantations and reconstructions o Arthrodeses of joints involving small bones o Osteotomies, including deformity correction such as rotation, lengthening, shortening o Pathological fractures, including impending pathologic fractures

Source page: https://510kreport.com/device/K150099
Methodology: https://510kreport.com/methodology