DePuy ATTUNE Knee System— 510(k) K252887

Name: FDA 510(k) clearance K252887
Creator: U.S. Food and Drug Administration
Published: 2026-05-22

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K252887 for DePuy ATTUNE Knee System, Substantially Equivalent on 2026-05-22. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.

Summary

DePuy Orthopaedics' DePuy ATTUNE Knee System is filed under OIY, which the record names "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive".

Class II, 21 CFR 888.3560. Orthopedic is both the classification panel and the review panel. The submission was a Traditional 510(k).

DePuy filed from Warsaw, Indiana. The decision came 254 calendar days after receipt (September 10, 2025 to May 22, 2026).

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Product code OIY
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2025-09-10
Decision date: 2026-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K120038 — A200 KNEE SYSTEM2013-02-14
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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.