# K051083: Acumed Scapula Congruent Bone Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: May 12, 2005 after 15 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: 3 generations back to K000684 (2000). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 1.
- K011335: Synths One-Third Tubular DCL Plate, Synthes (Usa) (2001) Summary page 1.

## Most influential descendants
- K243275: Equinoxe® Scapula Fracture System (2025), 0 descendants of its own
- K240181: Clavicle and Scapula System (2024), 0 descendants of its own

## Indications for use
The Acumed Scapula Congruent Bone Plate System provides fixation during fractures, fusions, and osteotomies for the scapula,

Source page: https://510kreport.com/device/K051083
Methodology: https://510kreport.com/methodology