# K092754: Sbi Foot and Ankle Cannulated Screw System, Model 100-0061

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, Inc.
- Decided: Jan 19, 2010 after 132 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962011 (1996). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996)
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 2.
- K052483: Synthes (Usa) Spherical Washers, Synthes (Usa) (2005) Summary page 2.
- K983006: Osteo 5.0MM Cannulated Screw System, Stryker Osteonics (1998) Summary page 2.
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 2.

## Most influential descendants
- K161894: SurgTech Trauma System (2017), 3 descendants of its own
- K242939: ARTFX Trauma Bone Plate and Screw System (2024), 2 descendants of its own
- K261830: FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) (2026), 0 descendants of its own
- K260277: Mikron Trauma Bone Plate& Screw System (2026), 0 descendants of its own

## Indications for use
The SBi Foot and Ankle Cannulated Screw System is indicated for fixation of small and long bones, such as femoral neck fractures; slipped capitol femoral epiphysis; tibial plateau fractures; ankle arthrodesis;, pediatric femur fractures; intercondylar femur fractures; sacroiliac joint disruptions; and subtalar arthrodesis. The system is not intended for spinal use.

Source page: https://510kreport.com/device/K092754
Methodology: https://510kreport.com/methodology