# K151615: TiTHON Staple with OsseoTi Technology

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Oct 2, 2015 after 109 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: 5 generations back to K902307 (1990). 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)
- K142292: Speed, Speed Shift, Speed Titan, Speed Arc, Biomedical Enterprises, Inc. (2014) Summary page 4.

## Indications for use
• 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/K151615
Methodology: https://510kreport.com/methodology