# K143338: Argulated Locking Plates

- Pathway: 510(k) (Special)
- Applicant: Osteomed LP
- Decided: Apr 1, 2015 after 132 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954385 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080694: Osteomed Modular Locking Fixation System, Osteomed LP (2008) Summary page 4.

## Indications for use
The OSTEOMED ICON Modular Locking Fixation System is indicated for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The OsTEOMED ICON Angulated Locking Plate System implants and drills are intended for single use only.

Source page: https://510kreport.com/device/K143338
Methodology: https://510kreport.com/methodology