# K203381: Dynanail Mini Hybrid

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Jan 15, 2021 after 59 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K962616 (1996). 80 ancestors in all.
4 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)
- K182677: DynaNail Mini, MedShape, Inc. (2019) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Nov 17, 2021 · Class II · Z-0453-2022: The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seat

## 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/K203381
Methodology: https://510kreport.com/methodology