# K003397: Colles C Series Frame Sterile Pack

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Jan 29, 2001 after 89 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012294: Wristore Fixator (2002), 3 descendants of its own
- K042761: Wristore Distal Radius Fracture Fixator, 4600 Series (2004), 1 descendant of its own
- K101338: Newfix External Fixation System (2011), 0 descendants of its own
- K052498: Fragment Specific Fixator (2005), 0 descendants of its own
- K013503: Modification to: Sterile Colles Classic Fixator (2001), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K003397
Methodology: https://510kreport.com/methodology