# K152484: FastFrame External Fixation System - Distal Radius

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 4, 2015 after 95 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 K994143 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131413: Xtrafix Small External Fixation System, Zimmer, Inc. (2014) Summary page 4.
- K141697: Xtrafix External Fixation System, Xtrafix Small External Fixation System, Zimmer, Inc. (2014) Summary page 4.

## Indications for use
The FastFrame External Fixation System - Distal Radius is indicated for use in treatment of appropriately sized long bone (wrist and hand) fractures. Specifically, the system is intended for: -Stabilization of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; - Arthrodesis and osteotomies with associated soft tissue; - Stabilization of non-unions; and - Intraoperative temporary stabilization to assist with indirect reduction.

Source page: https://510kreport.com/device/K152484
Methodology: https://510kreport.com/methodology