DePuy ATTUNE Total Knee System— 510(k) K201347

Name: FDA 510(k) clearance K201347
Creator: U.S. Food and Drug Administration
Published: 2020-06-18

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K201347 for DePuy ATTUNE Total Knee System, Substantially Equivalent on 2020-06-18. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code OIY
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2020-05-21
Decision date: 2020-06-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K252887 — DePuy ATTUNE Knee System2026-05-22
K242665 — DePuy ATTUNE Total Knee System2024-11-01
K120038 — A200 KNEE SYSTEM2013-02-14
K121727 — MOVATION KNEE SYSTEM2012-08-15
K113756 — HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA2012-03-14

More clearances from DePuy Orthopaedics, Inc.

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K262130 — ATTUNE Revision Knee System2026-09-04
K231503 — CUPTIMIZE Advanced2023-08-22
K213839 — DePuy Corail AMT Hip Prosthesis2022-01-06
K210167 — DELTA XTEND Reverse Shoulder System2021-02-19
K203167 — DePuy Corail AMT Hip Prosthesis2020-11-19

Adverse events under product code OIY

product code OIY

Injury: 607
Total: 607

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.