# K980103: Acumed Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Mar 16, 1998 after 63 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 K926384 (1993). 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)
- K953877: Mitek Gii Anchor, Mitek Surgical Products, Inc. (1995) Summary page 1.
- K926384: Statak & Mini-Statak Soft Tissue Attachment Device, Zimmer, Inc. (1993) Summary page 1.
- K941691: Revo Rotator Cuff Repair System, Linvatec Corp. (1994) Summary page 1.

## Indications for use
This device is intended for anchoring soft tissue to bone in rotator cuff repairs of the shoulder and soft tissue repair of the foot and ankle.

Source page: https://510kreport.com/device/K980103
Methodology: https://510kreport.com/methodology