# K102107: Osstaple Chill

- Pathway: 510(k) (Special)
- Applicant: Biomedical Ent., Inc.
- Decided: Sep 3, 2010 after 38 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.
24 later devices descend from it; 3 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)
- None. The FDA summary names its predicate without a number.
- (no number) BME OSStaple™: named in the summary without a submission number

## Most influential descendants
- K124022: Speed Shift (2013), 20 descendants of its own
- 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

## Indications for use
The OSStaple™ Chill is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and Fixation of proximal tibial metaphysis osteotomy.

Source page: https://510kreport.com/device/K102107
Methodology: https://510kreport.com/methodology