# K182677: DynaNail Mini

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Feb 14, 2019 after 141 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: 11 generations back to K962616 (1996). 79 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140741: Salvation Beams and Bolts System, Wrightmedicaltechnologyinc (2014) Summary page 4.
- K171376: DynaNail TTC Fusion System, MedShape, Inc. (2017) Summary page 4.
- K101934: Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000, Medshape Solutions (2011) Summary page 4.
- K081071: Synthes 6.5MM Midfoot Fusion Bolt, Synthes (Usa) (2008) Summary page 4.

## Most influential descendants
- K203381: Dynanail Mini Hybrid (2021), 4 descendants of its own
- K240530: DynaNail Mini Tapered Hybrid (2024), 2 descendants of its own
- K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (2026), 1 descendant of its own
- K260995: DynaNail Helix® Fixation System (2026), 0 descendants of its own
- K212755: SIGNUS SACRONAIL® Transsacral Stabilization System (2022), 0 descendants of its own

## Indications for use
The DynaNail Mini Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

Source page: https://510kreport.com/device/K182677
Methodology: https://510kreport.com/methodology