Cleared Traditional

K161166 - StageOne Select Cement Spacer Molds for Temporary Hip Replacement (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K161166 · Biomet, Inc. · Orthopedic device
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Sep 2016
Decision
135d
Days
Class 2
Risk

K161166 is an FDA 510(k) clearance for the StageOne Select Cement Spacer Molds for Temporary Hip Replacement. Classified as Bone Cement, Antibiotic (product code MBB), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 8, 2016 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

Submission Details

510(k) Number K161166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2016
Decision Date September 08, 2016
Days to Decision 135 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBB Bone Cement, Antibiotic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MBB Bone Cement, Antibiotic

All 18
Devices cleared under the same product code (MBB) and FDA review panel - the closest regulatory comparables to K161166.
SpaceFix Shoulder Spacer
K252443 · G21, S.R.L. · Sep 2025
GENTAFIX® (1, 3, 3MV)
K242216 · Teknimed Sas · Dec 2024
Hip Spacer Molds
K240856 · Osartis GmbH · Nov 2024
StageOne™ Select Hip Cement Spacer Molds
K222760 · Biomet, Inc. · Dec 2022
StageOne™ Shoulder Cement Spacer Molds
K221968 · Biomet, Inc. · Sep 2022
StageOne Knee Cement Spacer Molds
K213287 · Biomet, Inc. · Sep 2022