# K030310: Synthes Stainless Steel Modular Hand System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 22, 2003 after 82 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.
151 later devices descend from it; 16 cite it directly.
0 of 152 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 no predicate by number.

## Most influential descendants
- K112583: Synthes Cortical Screws (2011), 118 descendants of its own
- K120854: Synthes VA LCP Ankle Trauma System (2012), 44 descendants of its own
- K161616: DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw (2017), 33 descendants of its own
- K143385: Acumed Ankle Plating System (2015), 23 descendants of its own
- K151886: Acumed Ankle and Small Fragment Base Set Update (2015), 15 descendants of its own

## Indications for use
The Synthes Stainless Steel Modular Hand System consists of plates and screws intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.

Source page: https://510kreport.com/device/K030310
Methodology: https://510kreport.com/methodology