# K024022: Osteo-Cable Sleeve

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Jan 23, 2003 after 49 days
- Product code: HXN (Applier, Cerclage)
- Device class: 1
- Regulation: 21 CFR 888.4540
- 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
The Osteo-cable Sleeve is indicated for general orthopedic repairs, such as: Femur And Tibial Fractures Prophylactic Banding Trochanteric Reattachment Olecranon Fractures Patella Fractures Ankle Fractures Fixation Of Spiral Fractures In Conjunction With I/M Nailing And Screwing Techniques Sternum Fixation After Open Heart Surgery Stabilization Of Cortical Onlay Strut Graft

Source page: https://510kreport.com/device/K024022
Methodology: https://510kreport.com/methodology