# K262369: AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down

- Pathway: 510(k) (Special)
- Applicant: Stryker Endoscopy
- Decided: Jul 30, 2026 after 20 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
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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K153087: IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved, Ivy Sports Medicine, LLC (2016). Our reading of the summary gave K153087, FDA’s number for IvyAIR Meniscus System, Curved, IvyAIR Meniscus System… (Ivy Sports Medicine, LLC). Its FDA name has none of the distinctive words the summary uses for the device it names, “AIR+ All-Inside Meniscal Repair Device”. Kept off the family tree. Summary page 1.

## Indications for use
The AIR™+ All-Inside Meniscal Repair Device is intended for use as a suture retention device to facilitate arthroscopic soft tissue procedures. The AIR™+ All-Inside Meniscal Repair Device is indicated for use in meniscal repairs and allograft transplant procedures in adolescents. The AIR™+ All-Inside Meniscal Repair Device is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.

Source page: https://510kreport.com/device/K262369
Methodology: https://510kreport.com/methodology
