# K133541: Emerge Medical Small and Large Non-Locking Fragment Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Emerge Medical
- Decided: Jan 28, 2014 after 71 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: 5 generations back to K981372 (1998). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000684: Small Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000) Summary page 1.
- K001941: Synthes Modular Foot System, Synthes (Usa) (2000)
- K010766: Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T Plate, Synthes (Usa) (2001) Summary page 1.
- K020872: Synthes 3.5 MM Broad LC-DCP Plates, Synthes (Usa) (2002) Summary page 1.
- K082807: Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded Indications, Synthes (Usa) (2008) Summary page 1.
- K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP), Synthes (Usa) (2009) Summary page 1.
- K001945: Synthes (Usa) Medial Distal Tibia Plates, Synthes (Usa) (2000) Summary page 1.
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 1.
- K010518: Synthes Anterolateral Calcaneal Plate, Synthes (Usa) (2001) Summary page 1.
- K013248: Synthes LCP Distal Tibia Plates, Synthes (Usa) (2001) Summary page 1.
- K122936: Ankle Trauma System, Orthopro, LLC (2013) Summary page 1.

## Cited in the summary but kept off the family tree
- K079291: Synthes Reconstructive Y-Plate. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Emerge Medical Large Plate System is intended for fixation for fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including clavicle, olecranon, ulna, humerus, femur, tibia, fibula, calcaneus, tarsals, and pelvis, including in osetopenic bone. The Emerge Medical Small Plate System is intended for fixation for fractures, osteotomies, non-unions, deformations, revisions, replantations, of bones and bone fragments including clavicle, scapula, olecranon, humerus, radius, ulna, tibia, fibula, tarsals, metatarsals, phalanges, and calcaneus, including in osetopenic bone.

Source page: https://510kreport.com/device/K133541
Methodology: https://510kreport.com/methodology