# K193305: DynaClip Bone Staple

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Apr 23, 2020 after 146 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: 5 generations back to K902307 (1990). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150125: Elite Nitinol Fixation System, Biomedical Enterprises, Inc. (2015) Summary page 4.
- K142292: Speed, Speed Shift, Speed Titan, Speed Arc, Biomedical Enterprises, Inc. (2014) Summary page 4.

## Most influential descendants
- K220812: DynaClip® Bone Staple (2022), 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

## Indications for use
The MedShape DynaClip Bone Staple is intended to be used for the following: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Fixation of proximal tibial metaphysis osteotomy. Fixation of small bone fragments (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 bone such as the pelvis, scapula and sternum.

Source page: https://510kreport.com/device/K193305
Methodology: https://510kreport.com/methodology