# K261651: Precice™ Max System and Precice™ Ankle Salvage System

- Pathway: 510(k) (Special)
- Applicant: NuVasive Specialized Orthopedics
- Decided: Jun 18, 2026 after 30 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: 11 generations back to K831576 (1983). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170346: PRECICE Intramedullary Limb Lengthening System, Nuvasive Specialized Orthopedics, Inc. (2017) Summary page 5.
- K232267: Precice Max System, Nuvasive Specialized Orthopedics, Incorporated (2023) Summary page 5.
- K230765: Precice Ankle Salvage System, Nuvasive Specialized Orthopedics, Inc. (2023) Summary page 5.
- K220234: Precice Intramedullary Limb Lengthening System, Nuvasive Specialized Orthopedics, Inc. (2023) Summary page 5.

## Indications for use
Precice™ Max System The Precice™ Max System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, nonunions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old). Precice™ Ankle Salvage System The Precice™ Ankle Salvage System is indicated for tibio-talo-calcaneal fusions in adults. When used for tibio-talo-calcaneal 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/K261651
Methodology: https://510kreport.com/methodology