JuggerStitch Meniscal Repair Device— 510(k) K150424

Name: FDA 510(k) clearance K150424
Creator: U.S. Food and Drug Administration
Published: 2015-05-15

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K150424 for JuggerStitch Meniscal Repair Device, Substantially Equivalent on 2015-05-15. Applicant: Biomet Manufacturing Corp. Device class: 2.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2015-02-19
Decision date: 2015-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBI

view all

K253065 — Aevumed SUPERCYNCH Button System2026-09-02
K262809 — ArthroTAK Tendon Anchor Kit2026-09-02
K262677 — Iconix Knotless T2026-08-27
K262047 — Grappler Suture Anchor System2026-08-03
K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

More clearances from Biomet Manufacturing Corp

view all

K230540 — Patient Specific Planning Solution 3D Bone Models2023-07-25
K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System2023-03-15
K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner2021-11-04
K202232 — Comprehensive Vault Reconstruction System2021-02-19
K193038 — Comprehensive Shoulder System2020-10-28

Adverse events under product code MBI

product code MBI

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 →

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