# K000616: Smartwedge Acl, Models 430623, 430628, 430723, 430728, 430823, 430828

- Pathway: 510(k) (Special)
- Applicant: Bionx Implants, Ltd.
- Decided: Mar 23, 2000 after 28 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. FDA has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K000616
Methodology: https://510kreport.com/methodology