# K050462: Sbi Hand Fixation System (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, LLC
- Decided: Apr 26, 2005 after 62 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.
102 later devices descend from it; 2 cite it directly.
0 of 103 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 no predicate by number.

## Most influential descendants
- K101962: Mini Maxlock Extreme Plating System (2010), 85 descendants of its own
- K111041: Mini Variable System (2011), 77 descendants of its own
- K120157: Mini Maxlock Extreme Plating System (2012), 64 descendants of its own
- K121437: Mini Maxlock Extreme Plating System (2012), 38 descendants of its own
- K140397: Paralock Plating System / Tuffnek Screw (2014), 31 descendants of its own

## Indications for use
The SBI Hand Fixation System TM is a system of plates and screws that is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.

Source page: https://510kreport.com/device/K050462
Methodology: https://510kreport.com/methodology