BIOLOX(R) DELTA CERAMIC HEADS— 510(k) K131684

Clearance details

Applicant

Biomet, Inc.

Product code

Code LZO

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

2013-06-10

Decision date

2013-10-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• 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-0992-2018 — DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20170630
• Z-0993-2018 — JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20170630

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131684.