# K131867: 2.5MM Inline Fusion Plate

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 29, 2013 after 127 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 K041081 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093474: Depuy Fracture and Fusion Plating System, DePuy Orthopaedics, Inc. (2010) Summary page 1.
- K061748: Fragment Plate System, Hand Innovations, LLC (2006) Summary page 1.

## Indications for use
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteatomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 -21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.

Source page: https://510kreport.com/device/K131867
Methodology: https://510kreport.com/methodology