# K201321: DePuy Synthes 2.7mm VA LCP Clavicle Plate System

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Synthes
- Decided: Jul 24, 2020 after 67 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000684 (2000). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 4.
- K111540: Synthes 3.5MM LCP Clavicle Plate System, Synthes (Usa) (2011) Summary page 4.

## Most influential descendants
- K203414: DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System (2020), 1 descendant of its own
- K240181: Clavicle and Scapula System (2024), 0 descendants of its own
- K230805: TriMed Clavicle Fixation System (2023), 0 descendants of its own

## Recalls of this device
- Jan 24, 2024 · Class II · Z-1241-2024: Products not sterilized, sterility cannot be confirmed

## Indications for use
The DePuy Synthes 2.7mm VA LCP Clavicle Plate System is indicated for fixation of fractures, osteotomies, and non-unions of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

Source page: https://510kreport.com/device/K201321
Methodology: https://510kreport.com/methodology