DeviceClearance

AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down— 510(k) K262369

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K262369 for AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down, Substantially Equivalent on 2026-07-30. Applicant: Stryker Endoscopy. Device class: 2.

Summary

Stryker Endoscopy's AIR+ All-Inside Meniscal Repair Device comes in Curved Up and Curved Down versions, filed under MBI, nondegradable soft tissue fixation fasteners. The record doesn't give materials or sizes.

Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel, and it came in as a Special 510(k).

Stryker Endoscopy filed from San Jose, California. The decision came 20 calendar days after receipt (July 10 to July 30, 2026).

Clearance details

Device name as filed
AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down
Applicant
Stryker Endoscopy
Product code
Product code MBI
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Jose, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.