ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology— 510(k) K232303

Clearance details

Applicant

Depuy Ireland UC

Product code

Code MBH

Device class

Class 2

Regulation

21 CFR 888.3565

Advisory panel

Orthopedic

Date received

2023-08-01

Decision date

2023-12-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ringaskiddy, IE

• K261462 — LANDMARK Total Knee System2026-09-08
• K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
• K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
• K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09
• K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26

• K260480 — VELYS Robotic-Assisted Solution2026-06-25
• K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System2026-06-25
• K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
• K253624 — INHANCE Reverse Shoulder System2026-03-11
• K253551 — VELYS Hip Navigation2026-03-06

Injury

6,545

Malfunction

2,023

Total

8,568

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 →

• Z-1456-2024 — ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.Class II·Ongoing·DePuy Orthopaedics, Inc.·20240312

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K232303.