ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System— 510(k) K233980

Clearance details

Applicant

Depuy Ireland UC

Product code

Code KRO

Device class

Class 2

Regulation

21 CFR 888.3510

Advisory panel

Orthopedic

Date received

2023-12-18

Decision date

2024-03-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ringaskiddy, IE

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• K251665 — Triathlon® Hinge Knee System2025-07-25
• K242871 — ATTUNE Revision Hinge Knee2024-11-21

• 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

19

Injury

4,841

Total

4,860

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 →