ATTUNE Revision Knee System +6 more— 510(k) K241000

Clearance details

Device name as filed

ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System;

Applicant

Depuy Ireland UC

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2024-04-12

Decision date

2024-07-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ringaskiddy, Co. Cork, IE

• K260063 — GSPE Spacer2026-09-11
• K262293 — EVOLUTION MPX Total Knee System2026-09-10
• K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
• K262130 — ATTUNE Revision Knee System2026-09-04
• K253961 — SK Knee System2026-09-01

• 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

Death

26

Injury

51,564

Malfunction

9,725

Other

9

Total

61,324

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 →