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

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

Code MBI

Device class

Class 2

Regulation

21 CFR 888.3040

Advisory panel

Orthopedic

Date received

2026-07-10

Decision date

2026-07-30

Decision

Substantially Equivalent

Clearance type

Special

Location

San Jose, CA, US

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• K260185 — 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality2026-02-18
• K260108 — L12 LED Light Source with AIM2026-02-12

Injury

3,163

Malfunction

13,006

Other

2

Total

16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →