# K965228: Fasterner, Fixation, Biodegradable Soft Tissue

- Pathway: 510(k) (Traditional)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Nov 10, 1997 after 314 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 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) PDS II Suture, Ethicon, Inc.: named in the summary without a submission 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 Surgical Dynamics™ Meniscal Staple** is indicated for the repair of vertical longitudinal full thickness tears (i.e., bucket-handle) in the red-red and red-white zones.

Source page: https://510kreport.com/device/K965228
Methodology: https://510kreport.com/methodology