# K153087: IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved

- Pathway: 510(k) (Traditional)
- Applicant: Ivy Sports Medicine, LLC
- Decided: Jul 14, 2016 after 262 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K050021 (2005). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N, Smith & Nephew, Inc. (2012) Summary page 4.

## Indications for use
The IvyAIR Meniscus System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures. The lvyAIR Meniscus System is indicated for use in meniscal repairs and allograft transplant procedures. The IvyAIR Meniscus System device is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

Source page: https://510kreport.com/device/K153087
Methodology: https://510kreport.com/methodology