# K052576: Sbi Autofix

- Pathway: 510(k) (Traditional)
- Applicant: Small Bone Innovations, LLC
- Decided: Nov 7, 2005 after 49 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 10 cite it directly.
0 of 29 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
- K131920: Stabilization Screw (2014), 18 descendants of its own
- K160174: I.B.S. 2.0 Osteosynthesis screw (2016), 17 descendants of its own
- K170518: In2Bones Fracture and Correction System (2017), 15 descendants of its own
- K180377: Fracture and Correction System (2018), 7 descendants of its own
- K191535: CoLink® Mini Plating System (2019), 6 descendants of its own

## Recalls of this device
- May 19, 2014 · Class II · Z-2127-2014: Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.

## Indications for use
The SBi AutoFIX Twin Pitch Cannulated Compression Screw 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 bones.

Source page: https://510kreport.com/device/K052576
Methodology: https://510kreport.com/methodology