# K013890: Surgical Dynamics Meniscal Staple

- Pathway: 510(k) (Special)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Dec 11, 2001 after 18 days
- Product code: HWC (Screw, Fixation, Bone)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) currently marketed version of the Surgical Dynamics Meniscal Staple: named in the summary without a submission number

## Indications for use
The Surgical Dynamics Meniscal Staple is intended 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/K013890
Methodology: https://510kreport.com/methodology