# K990454: Bio-Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Jul 1, 1999 after 139 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 K971358 (1997). 1 ancestor in all.
119 later devices descend from it; 2 cite it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971358: Bio-Interference Screw, 7 MM, 8 MM, 9 MM, Arthrex, Inc. (1997) Summary page 1.

## Most influential descendants
- K993975: Absolute Absorbable Interference Screw (1999), 118 descendants of its own
- K013572: Mitek Biocryl Interference Screws (2002), 117 descendants of its own
- K032717: Biocryl Rapide Interference Screw (2004), 107 descendants of its own
- K060830: Milagro Interference Screw (2006), 103 descendants of its own
- K071176: Modification to: Arthrex Interference Screw (2007), 47 descendants of its own

## Indications for use
The Bio-Interference Screw is intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

Source page: https://510kreport.com/device/K990454
Methodology: https://510kreport.com/methodology