# K133536: Emerge Medical Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical
- Decided: Feb 26, 2014 after 100 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030310: Synthes Stainless Steel Modular Hand System, Synthes (Usa) (2003) Summary page 2.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000)
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 2.
- K063049: Synthes (Usa) Modular Mini Fragment LCP System, Synthes (Usa) (2006) Summary page 2.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 2.
- K010321: Modular Foot System - 2.7 MM Module, Synthes (Usa) (2001) Summary page 2.

## Indications for use
The Emerge Medical Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of small bones and bone fragments including tarsals, metatarsals, carpals, metacarpals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone. The Emerge Medical Non-Locking Mini Fragment System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations of small bones and bone fragments including tarsals, metatarsals, phalanges, calcaneus, hand, wrist, foot, and ankle, including in osteopenic bone. The Emerge Medical Non-Locking Modular Hand System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including phalanges, hand, and wrist, including in osteopenic bones. The Emerge Medical Modular Foot System is intended for fixation of fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including tarsals, metatarsals, calcaneus, foot, and ankle, including in osteopenic bone.

Source page: https://510kreport.com/device/K133536
Methodology: https://510kreport.com/methodology