# K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Mar 18, 2026 after 89 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: 14 generations back to K962616 (1996). 114 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 9.
- K203381: Dynanail Mini Hybrid, MedShape, Inc. (2021) Summary page 9.
- K240530: DynaNail Mini Tapered Hybrid, MedShape, Inc. (2024) Summary page 9.
- K203595: DynaFuse Fixation System, MedShape, Inc. (2022) Summary page 9.
- K181781: DynaClipTM Bone Staple, MedShape, Inc. (2018) Summary page 9.
- K193305: DynaClip Bone Staple, MedShape, Inc. (2020) Summary page 9.
- K220812: DynaClip® Bone Staple, MedShape, Inc. (2022) Summary page 9.

## Most influential descendants
- K260995: DynaNail Helix® Fixation System (2026), 0 descendants of its own

## Indications for use
The DynaNail Mini and DynaNail Hybrid System are indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of short bones, long bones, small fragments or large fragments in the foot and ankle. The DynaNail Helix 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. The DynaClip, DynaClip Forte, DynaClip Delta, DynaClip Quattro Bone Staples are indicated for * Fracture, osteotomy fixation and joint arthrodesis of the hand and foot. * Fixation of proximal tibial metaphysis osteotomy. * Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula, and sternum.

Source page: https://510kreport.com/device/K254110
Methodology: https://510kreport.com/methodology