# K071271: Biomet Cable System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Oct 23, 2007 after 169 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: 1 generation back to K920201 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920201: Titanium Alloy Songer Cable System, Sofamor Danek Mfg., Inc. (1992) Summary page 1.
- K925812: Titanium Songer Cable System, Sofamor Danek Mfg., Inc. (1993) Summary page 1.
- K030816: MSD Cable Reduction System, Medtronic Sofamor Danek (2003) Summary page 1.
- K922952: Songer Cable System, Pioneer Surgical Technology (1993) Summary page 1.

## Indications for use
The Biomet® Cable System is indicated for use whenever a conservative or non-implant surgery is deemed insufficient to improve the medical condition of the patient. The System can be utilized anywhere monofilament wire has been previously indicated. 1. Spinal applications include spinal degenerative surgery, as an adjunct to spinal fusions and sublaminar and intraspinous process wiring for trauma applications. The Biomet® Cable System may also be used with instrumentation involving the correction of scoliotic, kyphotic, and lordotic deformities. The titanium system is compatible with other titanium implants and the stainless steel system with stainless steel implants, wherever "wiring" may help secure the attachment of other implants. 2. Trochanteric reattachment after trochanteric osteotomy, following total hip arthroplasty. 3. Sternotomy indications include the "re-wiring" of sternums following osteotomy. 4. Trauma surgery indications include olecranon, ankle, patella, and some shoulder fracture rewiring.

Source page: https://510kreport.com/device/K071271
Methodology: https://510kreport.com/methodology