# K141905: Pro-Link Wedge System

- Pathway: 510(k) (Traditional)
- Applicant: Life Spine
- Decided: Sep 26, 2014 after 73 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: 10 generations back to K954385 (1996). 38 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093950: Biofoam Bone Wedge Model Assorted, Wrightmedicaltechnologyinc (2010) Summary page 4.
- K113048: Maxlock Extreme System, Orthohelix Surgical Designs, Inc. (2012) Summary page 4.

## Most influential descendants
- K150368: Tarsa-Link Wedge Fixation System (2015), 10 descendants of its own
- K161037: Tarsa-Link Stand-Alone Wedge Fixation System (2016), 9 descendants of its own
- 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

## Indications for use
The PRO-LINK Wedge and screws are 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/K141905
Methodology: https://510kreport.com/methodology