VANGUARD XP KNEE SYSTEM— 510(k) K122160

Clearance details

Applicant

Biomet Manufacturing Corp

Product code

Code MBH

Device class

Class 2

Regulation

21 CFR 888.3565

Advisory panel

Orthopedic

Date received

2012-07-20

Decision date

2013-03-20

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

• K230540 — Patient Specific Planning Solution 3D Bone Models2023-07-25
• K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System2023-03-15
• K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner2021-11-04
• K202232 — Comprehensive Vault Reconstruction System2021-02-19
• K193038 — Comprehensive Shoulder System2020-10-28

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-2503-2019 — XP- CR Tibial Tray- Interlok 59mm Item # 195268Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2515-2019 — XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2528-2019 — Vanguard XP Tibial Tray 63 mm Item # 195245Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2529-2019 — Vanguard XP Tibial Tray 65 mm Item # 195246Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2530-2019 — Vanguard XP Tibial Tray 67 mm Item # 195247Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2531-2019 — Vanguard XP Tibial Tray 69 mm Item # 195248Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2532-2019 — Vanguard XP Tibial Tray 71 mm Item # 195249Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2533-2019 — Vanguard XP Tibial Tray 73 mm Item # 195250Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2534-2019 — Vanguard XP Tibial Tray 75 mm Item # 195251Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2535-2019 — Vanguard XP Tibial Tray 79 mm Item # 195252Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2536-2019 — Vanguard XP Tibial Tray 83 mm Item # 195253Class II·Terminated·Zimmer Biomet, Inc.·20190815
• Z-2537-2019 — Vanguard XP Tibial Tray 87 mm Item # 195254Class 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 K122160.