# K203595: DynaFuse Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: MedShape, Inc.
- Decided: Jan 4, 2022 after 391 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: 7 generations back to K962823 (1996). 33 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153338: Tiger Cannulated Screw System, Trilliant Surgical, Ltd. (2016) Summary page 4.
- K133842: Tyber Medical Trauma Screw, Tyber Medical, LLC (2014) Summary page 4.
- K153575: Tyber Medical Trauma Screw, Tyber Medical, LLC (2016) Summary page 4.

## Most influential descendants
- K254110: DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro (2026), 1 descendant of its own
- K233567: OsteoCoil™ Nitinol Compression System (Multiple Component PNs) (2024), 1 descendant of its own
- K260995: DynaNail Helix® Fixation System (2026), 0 descendants of its own
- K260106: OsteoCoil™ GT Active Compression System (2026), 0 descendants of its own
- K252699: CoAptix S System (2026), 0 descendants of its own

## Indications for use
The MedShape DynaFuse 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.

Source page: https://510kreport.com/device/K203595
Methodology: https://510kreport.com/methodology