# K202348: External Remote Controller ERC 4P

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Inc.
- Decided: Dec 22, 2020 after 126 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: 12 generations back to K831576 (1983). 106 ancestors in all.
No later device cites it as a predicate yet.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191336: PRECICE System, Nuvasive Specialized Orthopedics, Inc. (2019) Summary page 4.
- K113219: Ellipse Precice Intramedullary Limb Lengthening System, Ellipse Technologies, Inc. (2012) Summary page 4.
- K192181: PRECICE Plating System, Nuvasive Specialized Orthopedics, Inc. (2019) Summary page 4.
- K200430: Precice® Ankle Salvage System, Nuvasive Specialized Orthopedics, Inc. (2020). Cleared while this submission was under review Summary page 4.

## Indications for use
The Precice® System (inclusive of Precice, Precice Stryde, and Precice Bone Transport) is indicated for limb-lengthening, open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions or bone transport of long bones. The Precice® Plating System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients. 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/K202348
Methodology: https://510kreport.com/methodology