# K982900: Phantom Softhread Soft Tissue Interference Screw

- Pathway: 510(k) (Special)
- Applicant: Depuy, Inc.
- Decided: Aug 31, 1998 after 14 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933738 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980440: Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw, Depuy, Inc. (1998) Summary page 1.

## Indications for use
The Phantom SofThread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.

Source page: https://510kreport.com/device/K982900
Methodology: https://510kreport.com/methodology