MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA— 510(k) K031693

Clearance details

Applicant

Biomet, Inc.

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2003-06-02

Decision date

2003-08-06

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15
• K213287 — StageOne Knee Cement Spacer Molds2022-09-02

Death

73

Injury

31,640

Malfunction

3,358

Other

2

Total

35,073

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-0622-2021 — M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.Class II·Terminated·Biomet, Inc.·20201125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031693.