ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP— 510(k) K213781

Clearance details

Applicant

Depuy Ireland UC

Product code

Code MBH

Device class

Class 2

Regulation

21 CFR 888.3565

Advisory panel

Orthopedic

Date received

2021-12-03

Decision date

2022-01-18

Decision

Substantially Equivalent

Clearance type

Special

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 K213781.