# K232267: Precice Max System

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Incorporated
- Decided: Dec 15, 2023 after 137 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K831576 (1983). 15 ancestors in all.
1 later device descends from it; 1 cites 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)
- K220234: Precice Intramedullary Limb Lengthening System, Nuvasive Specialized Orthopedics, Inc. (2023) Summary page 4.

## Most influential descendants
- K261651: Precice™ Max System and Precice™ Ankle Salvage System (2026), 0 descendants of its own

## Recalls of this device
- Sep 30, 2024 · Class II · Z-0500-2025: Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.

## Indications for use
The Precice Max System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, 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).

Source page: https://510kreport.com/device/K232267
Methodology: https://510kreport.com/methodology