# K082072: Synthes (Usa) 3.5MM LCP Hook Plate

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 7, 2008 after 108 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
No predicates in its family tree.
36 later devices descend from it; 7 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes One-Third Tubular DCL Plate: named in the summary without a submission number

## Most influential descendants
- K143394: Acumed Small Fragment Base Set (2015), 18 descendants of its own
- K151886: Acumed Ankle and Small Fragment Base Set Update (2015), 15 descendants of its own
- K181113: CoLink™ Afx Plating System (2018), 14 descendants of its own
- K191535: CoLink® Mini Plating System (2019), 6 descendants of its own
- K233665: DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System (2024), 4 descendants of its own

## Indications for use
Synthes 3.5mm LCP Hook Plate is indicated for fractures, osteotomies and non-unions of small bones including the ulna, radius, tibia and fibula, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K082072
Methodology: https://510kreport.com/methodology