# K063497: Modification to Scandius  Tritis Absorbable Tibial Reconstruction System

- Pathway: 510(k) (Special)
- Applicant: Scandius Biomedical, Inc.
- Decided: Dec 19, 2006 after 29 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
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 its predicate without a number.
- (no number) Scandius TriTis Absorbable Tibial Reconstruction System: named in the summary without a submission number

## Indications for use
The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.

Source page: https://510kreport.com/device/K063497
Methodology: https://510kreport.com/methodology