# K022515: Biomet Calcaneal Plate

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Sep 17, 2002 after 49 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 K981372 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991407: Synthes Locking Calcaneal Plates, Synthes (Usa) (1999) Summary page 1.
- K010518: Synthes Anterolateral Calcaneal Plate, Synthes (Usa) (2001) Summary page 1.
- K020401: Synthes Calcaneal Plate, Synthes (Usa) (2002) Summary page 1.
- K864924: Kirschner (R) Small Fragment Fixation System, Kirschner Medical Corp. (1987) Summary page 1.

## Indications for use
Intra-articular fractures of the calcaneus Extra-articular fractures of the calcaneus Osteotomies of the calcaneus

Source page: https://510kreport.com/device/K022515
Methodology: https://510kreport.com/methodology