ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS— 510(k) K051411

Clearance details

Applicant

Biomet, Inc.

Product code

Code LZO

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

2005-05-31

Decision date

2005-06-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

• K253948 — Momentum Acetabular Cup System2026-09-02
• K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)2026-07-06
• K260831 — Z1 Hip System2026-06-16
• K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
• K260037 — implantcast Packaging System Update2026-03-30

• 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

Death

17

Injury

12,942

Malfunction

1,756

Total

14,715

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-2145-2020 — Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.Class II·Terminated·Biomet, Inc.·20200417

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051411.