Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line— 510(k) K260921

Name: FDA 510(k) clearance K260921
Creator: U.S. Food and Drug Administration
Published: 2026-04-21

Substantially Equivalent

Tigon Medical

FDA 510(k) clearance K260921 for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line, Substantially Equivalent on 2026-04-21. Applicant: Tigon Medical. Device class: 2.

Clearance details

Applicant: Tigon Medical
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2026-03-19
Decision date: 2026-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Millersville, MD, 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 Tigon Medical

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K252596 — Tigon Medical Knotless and Dual Javelin All-Suture Anchors2025-12-04
K242529 — Tigon Medical All-Suture Anchors (ASA)2024-12-20
K240175 — Tigon Medical Fractures, Instability, and Reconstruction (FIRE)2024-10-29
K220464 — Tigon Medical Gryphon Anchor Line2023-03-22
K211049 — Tigon Medical Button System2021-08-04

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.