# K142292: Speed, Speed Shift, Speed Titan, Speed Arc

- Pathway: 510(k) (Traditional)
- Applicant: Biomedical Enterprises, Inc.
- Decided: Nov 17, 2014 after 91 days
- Product code: JDR (Staple, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K902307 (1990). 8 ancestors in all.
13 later devices descend from it; 9 cite it directly.
0 of 22 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 4.
- K001354: Memograph; Osstaple - Orthopedic Uses for Small Bone and Fragment Fixation for the Memograph Staple System, Biomedical Ent., Inc. (2001) Summary page 4.
- K124022: Speed Shift, Biomedical Enterprises, Inc. (2013) Summary page 4.
- K133270: Speed Arc, Biomedical Enterprises, Inc. (2014) Summary page 4.
- K133780: Speed XL, Biomedical Ent., Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K260995: DynaNail Helix® Fixation System (2026), 0 descendants of its own

## Recalls of this device
- Sep 27, 2022 · Class II · Z-0098-2023: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the inco
- Sep 27, 2022 · Class II · Z-0100-2023: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the inco
- Sep 27, 2022 · Class II · Z-0099-2023: The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the inco

## Indications for use
The Speed™, Speed Shift™, Speed Titan™ and Speed Arc™ are indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Fixation of proximal tibial metaphysis osteotomy. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. 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/K142292
Methodology: https://510kreport.com/methodology