# K051747: Sbi Wristfit

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, LLC
- Decided: Sep 6, 2005 after 69 days
- Product code: HRS (Plate, 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
SBI WristFITTM (Fracture In Tension) Distal Radius System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small and long bones. This includes: distal radius fractures distal ulna fractures radial osteotomies radial fusions tarsal fractures

Source page: https://510kreport.com/device/K051747
Methodology: https://510kreport.com/methodology