# K071952: Graftlock Screw, ST Screw

- Pathway: 510(k) (Special)
- Applicant: Biocomposites, Ltd.
- Decided: Aug 14, 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The GraftLok T M 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 GraftLokTM Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction. The GraftLokTM Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi tendonosis gracilis). The GraftLokTM ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures. The GraftLokTM ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.

Source page: https://510kreport.com/device/K071952
Methodology: https://510kreport.com/methodology