# K931246: Cerclage Wire Crimp Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Feb 22, 1994 after 348 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K101170: Acute Innovations Sternal Fixation System (2010), 10 descendants of its own
- K113318: Acute Innovations Modular Ribloc System (2012), 8 descendants of its own
- K141241: Matrixrib Endo Thoracoscopic Rib Plating System (2014), 5 descendants of its own
- K183317: AdvantageRib System (2019), 4 descendants of its own
- K203474: Biomet Microfixation RibFix Advantage System (2021), 3 descendants of its own

Source page: https://510kreport.com/device/K931246
Methodology: https://510kreport.com/methodology