# K012798: Intex Screw

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Nov 16, 2001 after 87 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 Intex Screw is indicated for fixation of bone fractures and for bone reconstruction (i.e. fresh fractures, osteotomy, revision procedure where other treatments or devices have failed, arthrodesis, and in conjunction with fixation hardware).

Source page: https://510kreport.com/device/K012798
Methodology: https://510kreport.com/methodology