# K073281: Cais Staple

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: May 2, 2008 after 163 days
- Product code: JDR (Staple, Fixation, Bone)
- 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: 2 generations back to K946271 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021953: Mitek PDS/Pga Staple, Mitek Worldwide (2002) Summary page 1.

## Indications for use
The CAIS Staple is an absorbable implant used in the fixation of periosteal autograft to articular cartilage lesions of the knee.

Source page: https://510kreport.com/device/K073281
Methodology: https://510kreport.com/methodology