# K111032: CMC Cable Fix

- Pathway: 510(k) (Traditional)
- Applicant: Instratek, Inc.
- Decided: Aug 31, 2011 after 140 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K792022 (1979). 58 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090107: Mini Tightrope, Arthrex, Inc. (2009) Summary page 1.
- K091763: Michelangelo Bunion System - Mabs, Model: MA6000, Instratek, Inc. (2009) Summary page 1.

## Most influential descendants
- K200332: EXPERT - Joint Fixation System (2020), 1 descendant of its own
- K242311: EXPERT - Flexible Joint Fixation System (2024), 0 descendants of its own

## Indications for use
The Instratek CIMO Cable Fix is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMVC Cable Fix is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpomnetacarpal (CIMO) arthritis and instability.

Source page: https://510kreport.com/device/K111032
Methodology: https://510kreport.com/methodology