ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART— 510(k) K082999

Name: FDA 510(k) clearance K082999
Creator: U.S. Food and Drug Administration
Published: 2008-12-30

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K082999 for ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART, Substantially Equivalent on 2008-12-30. Applicant: Arthrex, Inc.. Device class: 2.

Clearance details

Applicant: Arthrex, Inc.
Product code: Code MAI
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2008-10-08
Decision date: 2008-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAI

view all

K262357 — Arthrex Bioabsorbable PushLock Suture Anchors2026-08-07
K253931 — Arthrex Bioabsorbable PushLock Suture Anchors2026-05-28
K260294 — SF Push-in Anchor2026-03-27
K254055 — OSSIOfiber® Suture Anchor2026-02-24
K251680 — Biosteon® Screw2026-02-17

More clearances from Arthrex, Inc.

view all

K262451 — Arthrex DynaNite Staples2026-09-01
K260624 — Arthrex Radial Head Replacement System2026-07-30
K260018 — Arthrex FiberButton2026-06-26
K260809 — Arthrex Sterile VAL and VAL KreuLock Compression Screw System2026-06-25
K254215 — Arthrex Beaming System2026-05-08

Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.