# K112819: Reconstruction Locking Plate and 3.5MM Locking Screw

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Double Engline Medical Material Co., Ltd.
- Decided: Dec 16, 2011 after 79 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
Longest line of descent: 2 generations back to K983495 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092889: Syntec Osteo-Plate and Screw Fixation, Syntec Scientific Corp. (2010) Summary page 2.

## Most influential descendants
- K151508: IRENE Locking Compression Plate System (2016), 0 descendants of its own

## Indications for use
The Reconstruction Locking Plate and 3.5mm Locking Screw are used together and intended to treat fractures of various bones, including the clavicle and pelvis.

Source page: https://510kreport.com/device/K112819
Methodology: https://510kreport.com/methodology