# K031576: Spartan Orthopaedic Wrist Brace, Model SCT-1

- Pathway: 510(k) (Traditional)
- Applicant: Surgitech, Inc.
- Decided: Jul 31, 2003 after 72 days
- Product code: IQI (Orthosis, Limb Brace)
- Device class: 1
- Regulation: 21 CFR 890.3475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
An orthosis worn on the wrist for medical purposes: to support and/or immobilize for functional improvement. for conservative treatment of symptoms affiliated with Carpal Tunnel Syndrome, repetitive motion type injuries, sprains, strains and similar injuries of the wrist. to keep wrist motion to a minimum while worn allowing the body to recover from the damage of repetitive motion or other injuries. to provide temporary relief of associated symptoms of some wrist conditions.

Source page: https://510kreport.com/device/K031576
Methodology: https://510kreport.com/methodology