# K980690: Cable Screw with Integral Crimp

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: May 22, 1998 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Cable Screw with Integral Crimp is indicated where a fracture may not be securely held by either a screw or a cerclage cable alone The device can be used in conjunction with plating: humeral fractures niedial malleolus fractures butterfly fractures requiring interfragmentary fixation with cerclage cabling femur fractures pelvic fractures forearm shaft fractures patellar fractures olecranon fractures proximal tibial and tibial shaft fractures

Source page: https://510kreport.com/device/K980690
Methodology: https://510kreport.com/methodology