VANGUARD XP KNEE SYSTEM— 510(k) K132873

Clearance details

Applicant

Biomet, Inc.

Product code

Code MBH

Device class

Class 2

Regulation

21 CFR 888.3565

Advisory panel

Orthopedic

Date received

2013-09-13

Decision date

2013-12-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K261462 — LANDMARK Total Knee System2026-09-08
• K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
• K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
• K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09
• K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26

• 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

Injury

6,545

Malfunction

2,023

Total

8,568

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-2504-2019 — XP-CR Tibial Tray - Interlok 63mm Item # 195269Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2505-2019 — XP-CR Tibial Tray - Interlok 65mm Item # 195270Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2506-2019 — XP-CR Tibial Tray - Interlok 67mm Item # 195271Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2507-2019 — XP-CR Tibial Tray - Interlok 69mm Item # 195272Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2508-2019 — XP-CR Tibial Tray - Interlok 71mm Item # 195273Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2509-2019 — XP-CR Tibial Tray - Interlok 73mm Item # 195274Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2510-2019 — XP-CR Tibial Tray - Interlok 75mm Item # 195275Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2511-2019 — XP-CR Tibial Tray - Interlok 79 mm Item # 195276Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2512-2019 — XP-CR Tibial Tray - Interlok 83 mm Item # 195277Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2513-2019 — XP-CR Tibial Tray - Interlok 87 mm Item # 195278Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2514-2019 — XP-CR Tibial Tray - Interlok 91 mm Item # 195279Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2516-2019 — XP-XP Tibial Tray - Interlok 91mm Item # 195761Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2517-2019 — XP-XP Tibial Tray - Interlok 87 mm Item # 195760Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2518-2019 — XP-XP Tibial Tray - Interlok 83 mm Item # 195759Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2519-2019 — XP-XP Tibial Tray - Interlok 79 mm Item # 195758Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2520-2019 — XP-XP Tibial Tray - Interlok 75 mm Item # 195757Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2521-2019 — XP-XP Tibial Tray - Interlok 73 mm Item # 195756Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2522-2019 — XP-XP Tibial Tray - Interlok 71 mm Item # 195755Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2523-2019 — XP-XP Tibial Tray - Interlok 69 mm Item # 195754Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2524-2019 — XP-XP Tibial Tray - Interlok 67 mm Item # 195753Class II·Terminated·Zimmer Biomet, Inc.·20190815

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132873.