# K921480: Osteo-Clage (TM) Cerciage Cable System

- Pathway: 510(k) (Traditional)
- Applicant: Acu-Med, Inc.
- Decided: Jun 26, 1992 after 88 days
- Product code: JDQ (Cerclage, Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3010
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
25 later devices descend from it; 2 cite it directly.
0 of 26 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
- K971682: J-FX Cerclage System (1997), 24 descendants of its own
- K982545: BMP Cable System (1998), 17 descendants of its own
- K031162: Smith & Nephew Orthopaedic Cabling System (2003), 10 descendants of its own
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K203405: EVOS Large Fragment Plating System (2021), 3 descendants of its own

## Recalls of this device
- Mar 28, 2008 · Not classified · Z-2140-2008: Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping.

Source page: https://510kreport.com/device/K921480
Methodology: https://510kreport.com/methodology