# K111993: Framewalker

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Medical Concepts, LLC
- Decided: Oct 24, 2011 after 103 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: 2 generations back to K801594 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043289: E-Z Frame External Surgical Support Boot, Signal Medical Corp. (2005) Summary page 1.
- K083789: Ace Fischer External Fixation System, DePuy Orthopaedics, Inc. (2009) Summary page 1.

## Indications for use
This device is indicated for use in patients who are undergoing external ring fixation of the Foot and Ankle for the following conditions: For use in the treatment of fracture fixation (open and closed), pseudarthrosis or nonunions of long bones, limb lengthening by distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects.

Source page: https://510kreport.com/device/K111993
Methodology: https://510kreport.com/methodology