# K984490: Sutureless Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Mar 1, 1999 after 74 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
Longest line of descent: 1 generation back to K911837 (1991). 2 ancestors in all.
84 later devices descend from it; 3 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911837: Suretac Polyglyconate Absorbable Fixation Device, Acufex Microsurgical, Inc. (1991) Summary page 1.
- K973381: Bioroc EZ Suture Bone Fastener, Innovasive Devices, Inc. (1998) Summary page 1.

## Most influential descendants
- K020056: Duet Suture Anchor (2002), 78 descendants of its own
- K030388: Impact Suture Anchor. Model 433510 (2003), 77 descendants of its own
- K042966: Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models BXS4218, BXS4218H (2004), 76 descendants of its own
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own

## Indications for use
The Sutureless Anchor is intended for soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder.

Source page: https://510kreport.com/device/K984490
Methodology: https://510kreport.com/methodology