# K152755: FastFrame External Fixation System-Ankle Spanning

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 21, 2015 after 88 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: 4 generations back to K994143 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113383: Xtrafix External Fixation System, Extraortho, Inc. (2012) Summary page 4.

## Indications for use
The FastFrame External Fixation System - Ankle Spanning is indicated for use in treatment of distal tibia and foot fractures. Specifically, the system is intended for: - Stabilization of open or closed fractures about the ankle, 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 problems about the ankle; - Stabilization of limbs after removal of total ankle arthroplasty for infection or other failure; - Stabilization of non-unions about the ankle; and - Intraoperative temporary stabilization to assist with indirect reduction.

Source page: https://510kreport.com/device/K152755
Methodology: https://510kreport.com/methodology