ATTUNE Revision Knee System— 510(k) K160700

Name: FDA 510(k) clearance K160700
Creator: U.S. Food and Drug Administration
Published: 2016-06-10

Substantially Equivalent

Depuy(Ireland)

FDA 510(k) clearance K160700 for ATTUNE Revision Knee System, Substantially Equivalent on 2016-06-10. Applicant: Depuy(Ireland). Device class: 2.

Clearance details

Applicant: Depuy(Ireland)
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2016-03-14
Decision date: 2016-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cork, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

view all

K262057 — GMK Extension2026-09-15
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

More clearances from Depuy(Ireland)

view all

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
K191779 — Attune Revision LPS Inserts2019-10-08
K192448 — Delta Xtend Revers Shoulder System2019-10-04

Adverse events under product code JWH

product code JWH

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 →

Recalls naming K160700

K-number listed on FDA's recall record

Z-0631-2022 — ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003Class II·Terminated·DePuy Orthopaedics, Inc.·20220105
Z-0632-2022 — ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001Class II·Terminated·DePuy Orthopaedics, Inc.·20220105
Z-2348-2021 — ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080Class II·Terminated·DePuy Orthopaedics, Inc.·20210701
Z-1703-2018 — ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, KneeClass II·Terminated·DePuy Orthopaedics, Inc.·20180416
Z-1704-2018 — ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, KneeClass II·Terminated·DePuy Orthopaedics, Inc.·20180416

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160700.

Data sourced from openFDA. This site is unofficial and independent of the FDA.