# K160813: EasyStep

- Pathway: 510(k) (Traditional)
- Applicant: Stryker GmbH
- Decided: Jul 26, 2016 after 124 days
- Product code: JDR (Staple, Fixation, Bone)
- 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: 2 generations back to K902307 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 4.

## Indications for use
The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients. Indications include: • Bone fragment fixation • Osteotomy fixation

Source page: https://510kreport.com/device/K160813
Methodology: https://510kreport.com/methodology