# K013572: Mitek Biocryl Interference Screws

- Pathway: 510(k) (Special)
- Applicant: Mitek Products
- Decided: Mar 14, 2002 after 136 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: 3 generations back to K971358 (1997). 5 ancestors in all.
117 later devices descend from it; 6 cite it directly.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990454: Bio-Interference Screw, Innovasive Devices, Inc. (1999) Summary page 1.
- K993975: Absolute Absorbable Interference Screw, Innovasive Devices, Inc. (1999) Summary page 1.
- K993630: Biolok Screw, Encore Orthopedics, Inc. (2000) Summary page 1.
- K002070: Biolok Screw, Biocomposites, Ltd. (2000) Summary page 1.

## Most influential descendants
- 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
- K073412: Gryphon BR and Healix BR Anchors (2008), 44 descendants of its own
- K151342: Arthrex SwiveLock Anchors (2016), 38 descendants of its own

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

Source page: https://510kreport.com/device/K013572
Methodology: https://510kreport.com/methodology