# K013657: Modification to: Biomet Humeral Cable Plates

- Pathway: 510(k) (Special)
- Applicant: Biomet Orthopedics, Inc.
- Decided: Dec 3, 2001 after 27 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: 4 generations back to K844068 (1985). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982545: BMP Cable System, Biomet, Inc. (1998) Summary page 1.

## Indications for use
Fixation of a humeral fracture near the site of an intramedullary implant. Fixation of fractures where a combination of screws and cerclage cables would improve stabilization.

Source page: https://510kreport.com/device/K013657
Methodology: https://510kreport.com/methodology