# K082999: Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral Dart

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Dec 30, 2008 after 83 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 K983577 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983577: Arthrex Meniscal Dart System, Arthrex, Inc. (1999) Summary page 1.
- K991971: Arthrex Chondral Dart, Model AR-4005B-18, Arthrex, Inc. (2000) Summary page 1.

## 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. The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpa/metatarsal), osteochondral fragments (talus vault, femoral chondyle) and cancellous fragments (talus).

Source page: https://510kreport.com/device/K082999
Methodology: https://510kreport.com/methodology