# K133780: Speed XL

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Ent., Inc.
- Decided: Mar 19, 2014 after 97 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: 3 generations back to K902307 (1990). 5 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124022: Speed Shift, Biomedical Enterprises, Inc. (2013) Summary page 1.

## Most influential descendants
- K142292: Speed, Speed Shift, Speed Titan, Speed Arc (2014), 13 descendants of its own
- K150125: Elite Nitinol Fixation System (2015), 5 descendants of its own
- K193305: DynaClip Bone Staple (2020), 3 descendants of its own
- 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

## Indications for use
The Speed XL™ is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

Source page: https://510kreport.com/device/K133780
Methodology: https://510kreport.com/methodology