# K221792: Acute QC Strut and Components

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Aug 25, 2022 after 65 days
- Product code: OSN (Software For Diagnosis/Treatment)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K962616 (1996). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210953: SMART Taylor Spatial Frame, Smith & Nephew, Inc. (2021) Summary page 4.
- K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories], Smith & Nephew, Inc. (2000) Summary page 4.

## Indications for use
1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 2. Open and closed fracture fixation 3. Pseudarthrosis of long bones 4. Limb lengthening by distraction 5. Correction of bony or soft tissue deformities 6. Joint arthrodesis 7. Infected fractures 8. Nonunions

Source page: https://510kreport.com/device/K221792
Methodology: https://510kreport.com/methodology