VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL— 510(k) K141407

Clearance details

Applicant

Biomet, Inc.

Product code

Code MBH

Device class

Class 2

Regulation

21 CFR 888.3565

Advisory panel

Orthopedic

Date received

2014-05-28

Decision date

2014-10-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• 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-1265-2016 — Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymerClass II·Terminated·Biomet, Inc.·20160205

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141407.