VersaTap Suture Anchor (ADP050) +4 more— 510(k) K242296

Name: FDA 510(k) clearance K242296
Creator: U.S. Food and Drug Administration
Published: 2024-08-29

Substantially Equivalent

Ortho-Design (Pty), Ltd.

FDA 510(k) clearance K242296 for VersaTap Suture Anchor (ADP050) +4 more, Substantially Equivalent on 2024-08-29. Applicant: Ortho-Design (Pty), Ltd.. Device class: 2.

Clearance details

Device name as filed: VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)
Applicant: Ortho-Design (Pty), Ltd.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2024-08-02
Decision date: 2024-08-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Hazelwood, ZA

Download summary PDF View on FDA.gov ↗

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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 Ortho-Design (Pty), Ltd.

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K212381 — VersaTap, VersaLat, DueLock, VersaTi, MiniTi2021-12-06

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.