# K990804: Stayfuse

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Apr 29, 1999 after 50 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
106 later devices descend from it; 8 cite it directly.
0 of 107 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) K-Wire: named in the summary without a submission number

## Most influential descendants
- K022726: Stayfuse GT-IP (2002), 65 descendants of its own
- K082934: Extremity Medical Midfoot Screw System (2009), 63 descendants of its own
- K101700: IO Fix Hand, IO Fix Foot, Extremity Medical Screw System (2010), 56 descendants of its own
- K113006: I-Fuse Hammer Toe Systems (2012), 27 descendants of its own
- K171018: Axis Charcot Fixation System, 4.5 to 8.5mm Screw System (2017), 24 descendants of its own

## Recalls of this device
- Jan 20, 2004 · Not classified · Z-0561-04: Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.
- May 28, 2003 · Not classified · Z-0948-03: Label may bear an incorrect part number [2227-02-02] and size [03.8MM].

## Indications for use
The StayFuse is a screw device designed for small bone fusion and fractures. It is indicated for fractures, and inter-digital fusion of the fingers, toes and small bones.

Source page: https://510kreport.com/device/K990804
Methodology: https://510kreport.com/methodology