# K133354: Peri-Prosthetic Cable System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 27, 2014 after 88 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- 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
Intended for use in femur and tibia fractures, prophylactic banding, trochanteric reattachment, olecranon fractures, patella fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary railing and screwing techniques, sternum fixation after open chest surgery and stabilization of cortical onlay strut grafts.

Source page: https://510kreport.com/device/K133354
Methodology: https://510kreport.com/methodology