# K071091: Modification to Bilok Screw

- Pathway: 510(k) (Special)
- Applicant: Biocomposites, Ltd.
- Decided: May 17, 2007 after 29 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K102410: Matryx Interference Screw (5.0-6.5MM) (2010), 2 descendants of its own
- K120589: Milagro Interference Screws (2012), 1 descendant of its own
- K122869: Milagro Interference Screws (2012), 0 descendants of its own

## Indications for use
The Bilok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon places the graft in tibial and/or femoral tunnels and inserts screws between the tunnel wall and graft to hold the graft in place. The Bilok® Screw is used to provide interference fixation of patellar bone- tendon-bone grafts in ACL reconstruction. The Bilok®Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi tendonosis gracilis).

Source page: https://510kreport.com/device/K071091
Methodology: https://510kreport.com/methodology