SIRIUS FEMORAL STEM— 510(k) K130610

Clearance details

Applicant

Biomet, Inc.

Product code

Code JDI

Device class

Class 2

Regulation

21 CFR 888.3350

Advisory panel

Orthopedic

Date received

2013-03-07

Decision date

2013-08-30

Decision

Substantially Equivalent

Clearance type

Traditional

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-0822-2015 — Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.Class II·Terminated·Biomet, Inc.·20141202
• Z-0823-2015 — Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.Class II·Terminated·Biomet, Inc.·20141202

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130610.