# K983577: Arthrex Meniscal Dart System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 13, 1999 after 304 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.
4 later devices descend from it; 4 cite it directly.
0 of 5 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) Bionx Arrow: named in the summary without a submission number
- (no number) Clearfix: named in the summary without a submission number

## Most influential descendants
- K082999: Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral Dart (2008), 0 descendants of its own
- K070178: Aesculap Resorbable Pin, Model FR735 (2007), 0 descendants of its own
- K053492: Bioduct (2007), 0 descendants of its own
- K041128: Suture Arrow (2004), 0 descendants of its own

## Indications for use
The Arthrex Meniscal Dart System is intended for the repair of meniscal tears that would otherwise be considered for standard repair using suture

Source page: https://510kreport.com/device/K983577
Methodology: https://510kreport.com/methodology