# K991971: Arthrex Chondral Dart, Model AR-4005B-18

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Aug 4, 2000 after 420 days
- Product code: HTY (Pin, Fixation, Smooth)
- 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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 no predicate by number.

## Most influential descendants
- K082999: Arthrex Meniscal Dart, Arthrex Meniscal Dartstick, Arthrex Chondral Dart (2008), 0 descendants of its own
- K071616: Arc Surgical Biotrak Pin System (2007), 0 descendants of its own

## Indications for use
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, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral condyle) and cancellous fragments (talus).

Source page: https://510kreport.com/device/K991971
Methodology: https://510kreport.com/methodology