# K200430: Precice® Ankle Salvage System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Sep 16, 2020 after 208 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K974781 (1998). 13 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171376: DynaNail TTC Fusion System, MedShape, Inc. (2017) Summary page 4.
- K180503: PRECICE STRYDE System, Nuvasive Specialized Orthopedics, Inc. (2018) Summary page 4.

## Most influential descendants
- K230765: Precice Ankle Salvage System (2023), 1 descendant of its own
- K261651: Precice™ Max System and Precice™ Ankle Salvage System (2026), 0 descendants of its own
- K202348: External Remote Controller ERC 4P (2020), 0 descendants of its own

## Indications for use
The Precice Ankle Salvage System is intended for tibio-talo-calcaneal fusions. When used for TTC fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.

Source page: https://510kreport.com/device/K200430
Methodology: https://510kreport.com/methodology