MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL— 510(k) K003429

Clearance details

Applicant

Biomet, Inc.

Product code

Code LPH

Device class

Class 2

Regulation

21 CFR 888.3358

Advisory panel

Orthopedic

Date received

2000-11-03

Decision date

2000-11-30

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

• K253630 — Mpact 3D Metal Foam2026-08-28
• K254043 — TRIVANCE Hip Stem2026-08-04
• K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
• K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
• K251270 — Taperloc® Complete Hip Stem2026-05-19

• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• 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
• 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-1754-2015 — Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.Class III·Terminated·Biomet, Inc.·20150416

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003429.