DeviceClearance

ATTUNE Revision Hinge Knee— 510(k) K242871

Substantially Equivalent

Depuy Ireland UC

FDA 510(k) clearance K242871 for ATTUNE Revision Hinge Knee, Substantially Equivalent on 2024-11-21. Applicant: Depuy Ireland UC. Device class: 2.

Clearance details

Applicant
Depuy Ireland UC
Product code
Code KRO
Device class
Class 2
Regulation
21 CFR 888.3510
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ringaskiddy, IE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code KRO

product code KRO
Death
19
Injury
4,841
Total
4,860

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K242871

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K242871.

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