# K960692: Subtalar Mba System

- Pathway: 510(k) (Traditional)
- Applicant: Kinetikos Medical, Inc.
- Decided: Jul 23, 1996 after 154 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K792670 (1980). 1 ancestor in all.
57 later devices descend from it; 9 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K792670: Smith Subtalar Peg, Dow Corning Wright (1980) Summary page 3.

## Most influential descendants
- K071498: Subtalar Implant (2007), 32 descendants of its own
- K133636: Extremity Medical Hammertoe Device (2014), 31 descendants of its own
- K141857: CrossTie Intraosseous Fixation System (2015), 16 descendants of its own
- K031155: Osteomed Subtalar Implant System (2003), 16 descendants of its own
- K151270: CrossTIE Intraosseous Fixation System (2015), 15 descendants of its own

## Indications for use
The KMI Subtalar MBA System™ will be used on indications that are common with presently marketed devices. The primary indications for use of the Subtalar MBA System™ is as a spacer for stabilization of the subtalar joint. It is designed to block the anterior and inferior displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.

Source page: https://510kreport.com/device/K960692
Methodology: https://510kreport.com/methodology