# K981340: Innovasive Devices Meniscal Dart Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Jun 22, 1998 after 70 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Biofix Arrow: named in the summary without a submission number

## Indications for use
The intended use of the Meniscal Screw is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

Source page: https://510kreport.com/device/K981340
Methodology: https://510kreport.com/methodology