# K994152: The Ligament Anchor Soft Screw

- Pathway: 510(k) (Traditional)
- Applicant: Corin USA
- Decided: Mar 6, 2000 after 89 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K947134: Smith & Nephew RCI Screw. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
The Corifix Ligament Anchor Soft Screw is used for anterior and posterior cruciate ligament reconstruction using hamstrings. This technique provides reduced soft-tissue morbidity and reduced post operative pain on kneeling whilst improving the cosmetic appearance for the patient. The hamstring surgical technique and the Corifix Ligament Anchor Soft Screw work together for fixation of a hamstring tendon graft, without bone block, to achieve anatomic aperture fixation of the hamstring tendon graft in the tibia or femur.

Source page: https://510kreport.com/device/K994152
Methodology: https://510kreport.com/methodology