# K063584: Sterling IF Screw Eyelet, Model CID3936 and Sterling Cross-Pin Eyelet, Model CID3937

- Pathway: 510(k) (Traditional)
- Applicant: Regeneration Technologies, Inc.
- Decided: May 9, 2007 after 159 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: 1 generation back to K060253 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060253: Sterling Interference Screw HT, Sterling Interference Screw ST., Regeneration Technologies, Inc. (2006) Summary page 1.
- (no number) LinX HT: named in the summary without a submission number
- (no number) Sterling Interference Screw ST: named in the summary without a submission number

## Indications for use
This device is for use in graft fixation (for example, ligament and tendon), in cruciate ligament reconstruction surgeries. The Sterling IF Screw Eyelet devices are to be used with Sterling Interference Screw HT.

Source page: https://510kreport.com/device/K063584
Methodology: https://510kreport.com/methodology
