# K160169: The Life Spine Subtalar Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: Jun 23, 2016 after 148 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 K042030 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070441: Metasurg Subtalar Implant, Metasurg (2007) Summary page 4.
- K042030: Hyprocure Subtalar Implant System, Graham Medical Technologies, LLC (2004) Summary page 4.

## Indications for use
The LIFE SPINE Subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. The LIFE SPINE Subtalar implants are intended for single use only.

Source page: https://510kreport.com/device/K160169
Methodology: https://510kreport.com/methodology