FEMORAL CEMENT RESTRICTOR— 510(k) K800144

Clearance details

Applicant

Biomet, Inc.

Product code

Code JDS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

1980-01-21

Decision date

1980-02-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

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• K253434 — OSSTM Orthopedic Salvage System2026-07-01
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• 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

Injury

1,776

Malfunction

1,509

Total

3,285

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-1858-2017 — various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to prevent cement progression in the diaphysis and, therefore, facilitate cement pressurization during the introduction of an implant.Class 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 K800144.