# K962132: Silkon Stainless Steel Cable System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Aug 8, 1996 after 66 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 K932687 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932687: Ame (R) Universial Cable System, American Medical Electronics, Inc. (1994) Summary page 2.

## Indications for use
The Osteonics® Silkon™ Stainless Steel Cable System is indicated for cervical, thoracic and lumbar spinal trauma and/or the correction of scoliosis, kyphosis, and lordosis deformities. The Osteonics” Silkon™ Stainless Steel Cable System is also indicated for trochanteric reattachment, sternotomy indications, and trauma to the shoulder, elbow, hip, knee and ankle.

Source page: https://510kreport.com/device/K962132
Methodology: https://510kreport.com/methodology