RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS— 510(k) K032396

Clearance details

Applicant

Biomet, Inc.

Product code

Code JDI

Device class

Class 2

Regulation

21 CFR 888.3350

Advisory panel

Orthopedic

Date received

2003-08-04

Decision date

2003-08-21

Decision

Substantially Equivalent

Clearance type

Special

Location

Warsaw, IN, US

• K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments2026-08-24
• K253434 — OSSTM Orthopedic Salvage System2026-07-01
• K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners2025-07-31
• K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems2024-10-21
• K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component2024-08-02

• 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
• K213287 — StageOne Knee Cement Spacer Molds2022-09-02

Death

65

Injury

12,943

Malfunction

1,681

Total

14,689

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-1538-2018 — Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.Class II·Terminated·Zimmer Biomet, Inc.·20180402
• Z-1008-2018 — 36MM COCR MODULAR HD -6MMClass II·Terminated·Zimmer Biomet, Inc.·20170915
• Z-1860-2017 — various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall E1 Liner Ringloc +3mm Neutral Max-Rom ArComXL Liner Ringloc +3mm Neutral Max-Rom E1 Liner Ringloc +5mm Neutral Max-Rom E1 Liner Ringloc 10 Degree ArCom Liner Ringloc 10 Degree Face Changing ArComXL Liner Ringloc 10 Degree Face Changing E1 Liner RingLoc Bi-Polar Ringloc Hi-Wall ArCom Liner RingLoc Hi-Wall ArComXL Liner RingLoc Hi-Wall E1 Liner Ringloc Neutral Max-Rom ArCom Liner RingLoc Neutral Max-Rom ArComXL Liner RingLoc Neutral Max-Rom E1 Liner Product Usage: For use in hip arthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20170217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K032396.