Attune Revision LPS Inserts— 510(k) K191779

Clearance details

Applicant

Depuy(Ireland)

Product code

Code KRO

Device class

Class 2

Regulation

21 CFR 888.3510

Advisory panel

Orthopedic

Date received

2019-07-02

Decision date

2019-10-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cork, IE

• K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System2026-08-06
• K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more2025-12-15
• K252303 — Stem Extension Line (USTAR II System)2025-08-22
• K251665 — Triathlon® Hinge Knee System2025-07-25
• K242871 — ATTUNE Revision Hinge Knee2024-11-21

• K212683 — GLOBAL ICON Stemless Shoulder System2022-01-19
• K192855 — DELTA XTEND(TM) Reverse Shoulder System2020-02-24
• K190344 — DePuy Corail AMT Hip Prosthesis2019-11-01
• K192448 — Delta Xtend Revers Shoulder System2019-10-04
• K183077 — Delta Xtend Reverse Shoulder System2019-05-17

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 →

• Z-1263-2023 — Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118Class II·Ongoing·DePuy Orthopaedics, Inc.·20230215
• Z-1264-2023 — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212Class II·Ongoing·DePuy Orthopaedics, Inc.·20230215
• Z-1265-2023 — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226Class II·Ongoing·DePuy Orthopaedics, Inc.·20230215
• Z-1266-2023 — Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312Class II·Ongoing·DePuy Orthopaedics, Inc.·20230215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191779.