StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis— 510(k) K161273

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K161273 for StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis, Substantially Equivalent on 2017-01-25. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code MBB
Advisory panel: Orthopedic
Date received: 2016-05-05
Decision date: 2017-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBB

product code MBB

Death: 27
Injury: 1,412
Malfunction: 551
Total: 1,990

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.