# K172973: Life Spine Foot and Ankle Plating System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Dec 21, 2017 after 86 days
- Product code: HRS (Plate, Fixation, Bone)
- 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: 13 generations back to K954385 (1996). 227 ancestors in all.
No later device cites it as a predicate yet.
0 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140397: Paralock Plating System / Tuffnek Screw, Paragon 28 (2014) Summary page 4.
- K101240: Closed Fusion Plate, MTP Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467, DePuy Orthopaedics, Inc. (2010) Summary page 4.
- K111678: Ortho Solutions Extremity Fixation Implants for Osteosysnthesis, Ortho Solutions Limited (2012) Summary page 4.
- K161037: Tarsa-Link Stand-Alone Wedge Fixation System, Life Spine, Inc. (2016) Summary page 4.

## Indications for use
The Life Spine Foot and Ankle Plating System is indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multifragmentary fractures; revision procedures, joint fusions, and reconstruction of the bones of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.

Source page: https://510kreport.com/device/K172973
Methodology: https://510kreport.com/methodology