# K980595: Depuy Orthotech Catera Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: May 11, 1998 after 83 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 1 generation back to K902751 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K926384: Statak & Mini-Statak Soft Tissue Attachment Device, Zimmer, Inc. (1993) Summary page 1.
- K902751: Mitek Anchor II, Mitek Surgical Products, Inc. (1990) Summary page 1.
- K920213: Mitek Anchor, Mitek Anchor II, Mitek Surgical Products, Inc. (1992) Summary page 1.

## Indications for use
The DePuy OrthoTech Catera Suture Anchor is intended for use in the shoulder for soft tissue re-attachment and capsular repair, including rotator cuff repairs, Bankart lesion repairs and SLAP lesion repairs.

Source page: https://510kreport.com/device/K980595
Methodology: https://510kreport.com/methodology