# K013503: Modification to: Sterile Colles Classic Fixator

- Pathway: 510(k) (Special)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Nov 16, 2001 after 25 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003397 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003397: Colles C Series Frame Sterile Pack, DePuy Orthopaedics, Inc. (2001) Summary page 1.

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0528-2020: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

## Indications for use
For use in the fixation of distal fractures of the upper extremity. External fixation systems allow control of bone segments including angulation, rotation and displacement.

Source page: https://510kreport.com/device/K013503
Methodology: https://510kreport.com/methodology