# K050468: Triabsorb Composite Screw

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Biomaterials
- Decided: Aug 31, 2005 after 189 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: 7 generations back to K933738 (1994). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013572: Mitek Biocryl Interference Screws, Mitek Products (2002) Summary page 1.
- K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,, Linvatec Biomaterials, Inc. (2004) Summary page 1.
- K002070: Biolok Screw, Biocomposites, Ltd. (2000) Summary page 1.
- K003641: Biolok Screw, Biosteon Screw, Biocomposites, Ltd. (2001) Summary page 1.

## Indications for use
To provide interference fixation of soft tissue graft and bone-tendon-bone patellar graft during the Anterior Cruciate Ligament repair through arthroscopy or arthrotomy.

Source page: https://510kreport.com/device/K050468
Methodology: https://510kreport.com/methodology