# K982095: Lactosorb Meniscal Repair Device

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jan 27, 1999 after 226 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- 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
No predicates in its family tree.
10 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041988: Arthrotek Meniscal Hybrid Device (2004), 7 descendants of its own
- 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

## Indications for use
The LactoSorb 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/K982095
Methodology: https://510kreport.com/methodology