# K133270: Speed Arc

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Enterprises, Inc.
- Decided: Apr 17, 2014 after 176 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
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K142292: Speed, Speed Shift, Speed Titan, Speed Arc (2014), 13 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
- K203180: Arthrex DynaNite Nitinol Staples (2020), 1 descendant of its own

Source page: https://510kreport.com/device/K133270
Methodology: https://510kreport.com/methodology