# K981692: Meniscal Repair Device

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jul 27, 1998 after 75 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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.
80 later devices descend from it; 1 cites it directly.
0 of 81 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) Linvatec Meniscal Repair Device: named in the summary without a submission number

## Most influential descendants
- K991715: Biostinger-V Bioabsorbable Meniscal Repair Device (1999), 79 descendants of its own
- K020377: Pre-Loaded Biostinger Hornet (2002), 76 descendants of its own
- K053561: Bio-Mini Revo Suture Anchor (2006), 75 descendants of its own
- K091549: Conmed Linvatec Soft Tissue to Bone System (2009), 56 descendants of its own
- K111779: Y-Knot All-Suture Anchor Model HF13 (2011), 29 descendants of its own

## Indications for use
The Meniscal Repair Device provides fixation of longitudinal vertical meniscus lesions (bucket-handle) located in the vascularized area of the meniscus. Implantation of the device is accomplished through arthroscopy or arthrotomy.

Source page: https://510kreport.com/device/K981692
Methodology: https://510kreport.com/methodology