# K131480: Emerge Medical Locking One-Third Tubular Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical
- Decided: Jul 3, 2013 after 42 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 K000684 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 1.

## Indications for use
The Emerge Locking One-third Tubular Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

Source page: https://510kreport.com/device/K131480
Methodology: https://510kreport.com/methodology