# K990340: Arthrex Pla Tissuetak, Model # AR-1940 BU

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Jan 28, 2000 after 359 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.
79 later devices descend from it; 2 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Acufex Suretac: named in the summary without a submission number
- (no number) Bionx Bankart Tack: named in the summary without a submission number

## 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 TissueTak™ is intended for fixation of soft tissue to bone for reattachment of the glenoid labrum or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder in association with adequate post operative immobilization

Source page: https://510kreport.com/device/K990340
Methodology: https://510kreport.com/methodology