# K020872: Synthes 3.5 MM Broad LC-DCP Plates

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 12, 2002 after 86 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.
7 later devices descend from it; 3 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)
- None. Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate.

## Most influential descendants
- K031875: Inter-OS Limb Lengthener (2003), 4 descendants of its own
- K192181: PRECICE Plating System (2019), 2 descendants of its own
- K202348: External Remote Controller ERC 4P (2020), 0 descendants of its own
- K193617: Precice® Screws (2020), 0 descendants of its own
- K133541: Emerge Medical Small and Large Non-Locking Fragment Plate System (2014), 0 descendants of its own

## Indications for use
The Synthes 3.5 mm Broad LC-DCP Plates are intended for use on the diaphysis of the long bones (i.e., humerus, ulna, and tibia).

Source page: https://510kreport.com/device/K020872
Methodology: https://510kreport.com/methodology