# K092247: Synthes Locking Hand Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 25, 2009 after 59 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.
28 later devices descend from it; 8 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K213864: Bonebridge Osteosynthesis Plating System (2022), 8 descendants of its own
- K231292: TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus System (2023), 7 descendants of its own
- K141527: Depuy Synthes Variable Angle Locking Hand System (2015), 7 descendants of its own
- K240318: SITTER 3.5mm Versatile System (2024), 4 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
The Synthes Locking Hand Plates are intended for fixation of fractures. osteotomies, non-unions, replantations and fusions of small bones and small bone fragments, particularly in osteopenic bone.

Source page: https://510kreport.com/device/K092247
Methodology: https://510kreport.com/methodology