# K124022: Speed Shift

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Enterprises, Inc.
- Decided: May 14, 2013 after 137 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: 2 generations back to K902307 (1990). 4 ancestors in all.
20 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993714: Memograph Staple, Warm System, Biomedical Ent., Inc. (2000) Summary page 1.
- K102107: Osstaple Chill, Biomedical Ent., Inc. (2010) Summary page 1.

## Most influential descendants
- K133780: Speed XL (2014), 15 descendants of its own
- 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

## Indications for use
The Speed ShiftTM Fixation system is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

Source page: https://510kreport.com/device/K124022
Methodology: https://510kreport.com/methodology