# K993630: Biolok Screw

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Apr 26, 2000 after 182 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.
128 later devices descend from it; 2 cite it directly.
0 of 129 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) Bio Interference Screw (Arthrex): named in the summary without a submission number
- (no number) BioScrew (Linvatec): named in the summary without a submission number

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

## Indications for use
The BioLok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon: e 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 BioLok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The BioLok® 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/K993630
Methodology: https://510kreport.com/methodology