Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

StageOne Select Cement Spacer Molds for Temporary Hip Replacement

K-Number: K161166 · 2016-09-08

ApplicantBiomet, Inc.
Decision Date2016-09-08
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StageOne Select Cement Spacer Molds for Temporary Hip Replacement is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2016-09-08 under approval number K161166. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StageOne Select Cement Spacer Molds for Temporary Hip Replacement?

StageOne Select Cement Spacer Molds for Temporary Hip Replacement is a medical device that received FDA 510(k) clearance on 2016-09-08. It is manufactured by Biomet, Inc.. The 510(k) number is K161166.

When was StageOne Select Cement Spacer Molds for Temporary Hip Replacement approved by the FDA?

StageOne Select Cement Spacer Molds for Temporary Hip Replacement received FDA 510(k) clearance on 2016-09-08, under approval number K161166.

What company makes StageOne Select Cement Spacer Molds for Temporary Hip Replacement?

StageOne Select Cement Spacer Molds for Temporary Hip Replacement is manufactured by Biomet, Inc..

What is the FDA product code for StageOne Select Cement Spacer Molds for Temporary Hip Replacement?

The FDA product code for StageOne Select Cement Spacer Molds for Temporary Hip Replacement is MBB.

Related Clinical Trials

NCT05615844 Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy RECRUITING

Related PubMed Literature

PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

Other Devices by Biomet, Inc.

K161592Persona Partial Knee System K162424Ulna Plating System K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis K161190G7 Dual Mobility System, Active Articulation System K153657Vanguard XP Knee System K160058Biomet Variable Pitch Compression Screw System

View all 34 devices →

Related Devices (Code: MBB)

K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc. K161273StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisBiomet, Inc. K192041G21 SpaceFlex HipG21, S.R.L. K190216SpaceFlex KneeG21, S.R.L. K201960SpaceFlex Knee - 80mm SizeG21, S.R.L. K202338SpaceFlex ShoulderG21, S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑