Aevumed PHANTOM Suture Anchors— 510(k) K242895

Name: FDA 510(k) clearance K242895
Creator: U.S. Food and Drug Administration
Published: 2025-08-06

Substantially Equivalent

Aevumed, Inc.

FDA 510(k) clearance K242895 for Aevumed PHANTOM Suture Anchors, Substantially Equivalent on 2025-08-06. Applicant: Aevumed, Inc.. Device class: 2.

Clearance details

Applicant: Aevumed, Inc.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2024-09-23
Decision date: 2025-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBI

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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 Aevumed, Inc.

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K254306 — Aevumed FENIX Suture Anchor2026-03-04
K260004 — Aevumed PROTEKT Suture Anchor2026-01-28
K253040 — Aevumed FASE Suture Anchor2025-10-21
K223878 — Aevumed RAPID Suture Anchors2023-03-17
K222363 — Aevumed PHANTOM-LP Suture Anchors2022-11-28

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.