# K041988: Arthrotek Meniscal Hybrid Device

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 20, 2004 after 89 days
- Product code: JDR (Staple, Fixation, Bone)
- 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
Longest line of descent: 1 generation back to K965228 (1997). 2 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982095: Lactosorb Meniscal Repair Device, Biomet, Inc. (1999) Summary page 1.
- K965228: Fasterner, Fixation, Biodegradable Soft Tissue, United States Surgical, A Division of Tyco Healthc (1997) Summary page 1.

## Most influential descendants
- K061776: Arthrotek Maxfire Meniscal Repair Device (2006), 6 descendants of its own
- K111564: Maxfire Marxmen Meniscal Repair Device (2011), 5 descendants of its own
- K190125: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2019), 2 descendants of its own
- K221731: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2022), 1 descendant of its own
- K150424: JuggerStitch Meniscal Repair Device (2015), 1 descendant of its own

## Indications for use
The Arthrotek® Meniscal Hybrid Device is indicated for the 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/K041988
Methodology: https://510kreport.com/methodology