# K200343: FusionFrame Ring Lock System

- Pathway: 510(k) (Traditional)
- Applicant: Glw Medical Innovation
- Decided: Sep 14, 2020 after 216 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- 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: 6 generations back to K941048 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100857: Fusion Medical Ring Lock System, John J Riccio (2010) Summary page 4.
- K180832: SALVATION External Fixation System, Wrightmedicaltechnologyinc (2018) Summary page 4.
- K962808: Ilizarov External Fixation System, Smith & Nephew Richards, Inc. (1996) Summary page 4.

## Indications for use
The FusionFrame Ring Lock System is indicated for: • Stabilization of fractures and osteotomies; • Bone deformity correction of lower extremities; • Arthrodesis of the rear foot, mid foot and ankle joint; and • Limb Lengthening in pediatric and adult patients.

Source page: https://510kreport.com/device/K200343
Methodology: https://510kreport.com/methodology