# K980681: Innovasive Devices Meniscal Screw

- Pathway: 510(k) (Traditional)
- Applicant: Innovasive Devices, Inc.
- Decided: Apr 29, 1998 after 68 days
- Product code: HWC (Screw, Fixation, Bone)
- 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 its predicate without a number.
- (no number) Bionx Arrow: named in the summary without a submission number

## Most influential descendants
- K053492: Bioduct (2007), 0 descendants of its own
- K031714: Inion Trinion Biodegradable Meniscus Screw (2004), 0 descendants of its own

## 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/K980681
Methodology: https://510kreport.com/methodology