# K960651: Cerclage Wire Crimp Block

- Pathway: 510(k) (Traditional)
- Applicant: Acu-Med, Inc.
- Decided: May 3, 1996 after 78 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 K931246 (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)
- K931246: Cerclage Wire Crimp Sleeve, Acu Med, Inc. (1994) Summary page 1.
- (no number) Osteo-Clage Cerclage Cable System: named in the summary without a submission number
- (no number) Howmedica Dall-Miles Cable System: named in the summary without a submission number

## Indications for use
It is intended for use in general orthopedic repairs wherever cerclage wire is indicated.

Source page: https://510kreport.com/device/K960651
Methodology: https://510kreport.com/methodology