# K153415: Reprocessed Stryker External Fixation Devices

- Pathway: 510(k) (Special)
- Applicant: Stryker Sustainability Solutions
- Decided: Jan 13, 2016 after 49 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: 3 generations back to K802722 (1980). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052062: Alliance Medical Corporation Reprocessed External Fixation Devices, Alliance Medical Corp. (2005) Summary page 5.
- K012648: Reprocessed Howmedica External Fixation Devices, Alliance Medical Corp. (2002) Summary page 5.

## Indications for use
Reprocessed Stryker External Fixation Devices are indicated for use in patients requiring external fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

Source page: https://510kreport.com/device/K153415
Methodology: https://510kreport.com/methodology