# K111564: Maxfire Marxmen Meniscal Repair Device

- Pathway: 510(k) (Special)
- Applicant: Biomet Sports Medicine
- Decided: Jun 16, 2011 after 10 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: 3 generations back to K965228 (1997). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061776: Arthrotek Maxfire Meniscal Repair Device, Arthrotek, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K244015: SuperBall-RC™ (2025), 0 descendants of its own
- K191459: JuggerStitch Meniscal Repair Device (2019), 0 descendants of its own

## Indications for use
The Biomet Sports Medicine TM MaxfireTM MarXmenTM Meniscal Repair 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/K111564
Methodology: https://510kreport.com/methodology