# K260995: DynaNail Helix® Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Sep 23, 2026 after 181 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962616 (1996). 115 ancestors in all.
No later device cites it as a predicate yet.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182677: DynaNail Mini, MedShape, Inc. (2019) Summary page 6.
- K203595: DynaFuse Fixation System, MedShape, Inc. (2022) Summary page 6.
- K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro, MedShape, Inc. (2026) Summary page 6.
- K153338: Tiger Cannulated Screw System, Trilliant Surgical, Ltd. (2016) Summary page 6.

## Indications for use
The DynaNail Helix® Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device such as short bones, long bones, and small or large fragments in the foot and ankle.

Source page: https://510kreport.com/device/K260995
Methodology: https://510kreport.com/methodology