# K232733: Mbrace Cable

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: May 3, 2024 after 239 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: 5 generations back to K990088 (1999). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920201: Titanium Alloy Songer Cable System, Sofamor Danek Mfg., Inc. (1992) Summary page 5.
- K100006: HS Fiber (Polyblend), River Bond, Riversilk (Silk), Riverpro (Polypropylene), Riverlon (Nylon) Model Veries by Size/Need, Riverpoint Medical (2010) Summary page 5.

## Indications for use
The Mbrace Cable is designed as a cerclage system for long bones and to reattach the greater trochanter in case of fractures or osteotomies. The device is intended for long-term implantation inside the human body for single use only. The Mbrace Cable is not intended for use as a suture cable in soft tissue approximation and/or ligation.

Source page: https://510kreport.com/device/K232733
Methodology: https://510kreport.com/methodology