# K133844: Speed Triad

- Pathway: 510(k) (Special)
- Applicant: Biomedical Ent., Inc.
- Decided: Apr 7, 2014 after 110 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 K960385 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse, Memometal Technologies (2007) Summary page 1.

## Cited in the summary but kept off the family tree
- K093714: Sonoace X8 Diagnostic Ultrasound System, Medison Co., Ltd. (2009). Our reading of the summary gave K093714, FDA’s number for Sonoace X8 Diagnostic Ultrasound System (Medison Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “OSSplate”. Kept off the family tree. Summary page 1.

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

Source page: https://510kreport.com/device/K133844
Methodology: https://510kreport.com/methodology