VANGUARD 360 REVISION KNEE SYSTEM— 510(k) K093293

Name: FDA 510(k) clearance K093293
Creator: U.S. Food and Drug Administration
Published: 2010-10-22

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K093293 for VANGUARD 360 REVISION KNEE SYSTEM, Substantially Equivalent on 2010-10-22. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2009-10-21
Decision date: 2010-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

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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

More clearances from Biomet, Inc.

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K253434 — OSSTM Orthopedic Salvage System2026-07-01
K251270 — Taperloc® Complete Hip Stem2026-05-19
K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

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 K093293

K-number listed on FDA's recall record

Z-0723-2021 — Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422Class II·Terminated·Biomet, Inc.·20201201
Z-3249-2018 — Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee ArthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20180802
Z-3250-2018 — Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee ArthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20180802
Z-0003-2017 — Vanguard 360 Revision Knee System Knee prosthesesClass II·Terminated·Zimmer Biomet, Inc.·20160808
Z-2242-2014 — Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USAClass II·Terminated·Biomet, Inc.·20140701

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093293.

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