# K161037: Tarsa-Link Stand-Alone Wedge Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine, Inc.
- Decided: Aug 15, 2016 after 124 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: 12 generations back to K954385 (1996). 50 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150368: Tarsa-Link Wedge Fixation System, Life Spine (2015) Summary page 4.
- K113048: Maxlock Extreme System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.
- K120157: Mini Maxlock Extreme Plating System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.
- K142724: BIOFOAM Bone Wedge, Wrightmedicaltechnologyinc (2015) Summary page 4.
- K141905: Pro-Link Wedge System, Life Spine (2014) Summary page 4.

## Most influential descendants
- K192645: Trigon™ Ti Stand-Alone Wedge Fixation System (2019), 7 descendants of its own
- K193414: Trigon HA Stand-Alone Wedge Fixation System (2020), 6 descendants of its own
- K203445: Trigon HA Stand-Alone Wedge Fixation System (2020), 5 descendants of its own
- K220197: Trigon HA Wedge Fixation System (2022), 4 descendants of its own
- K243231: Trigon PEEK HA Wedges (2024), 1 descendant of its own

## Indications for use
The TARSA-LINK Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot, such as: • Opening wedge osteotomies of Hallux Valgus • Evans lengthening osteotomies • Metatarsal/cuneiform arthrodesis

Source page: https://510kreport.com/device/K161037
Methodology: https://510kreport.com/methodology