# K191459: JuggerStitch Meniscal Repair Device

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Sep 13, 2019 after 102 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
Longest line of descent: 5 generations back to K965228 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150424: JuggerStitch Meniscal Repair Device, Biomet Manufacturing Corp (2015) Summary page 4.
- K061776: Arthrotek Maxfire Meniscal Repair Device, Arthrotek, Inc. (2006) Summary page 4.

## Indications for use
The JuggerStitch Meniscal Repair Device is indicated for repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

Source page: https://510kreport.com/device/K191459
Methodology: https://510kreport.com/methodology