Cleared Traditional

K161166 - StageOne Select Cement Spacer Molds for Temporary Hip Replacement

K161166 is an FDA 510(k) clearance for StageOne Select Cement Spacer Molds for..., manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code MBB cleared through the Traditional 510(k) pathway after a 135-day FDA review.

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

FDA 510(k) Submission Details - K161166

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
PCCP Authorized No
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.

MBB Device Classification - Class 2, Special Controls

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.
G21 SpaceFlex Hip
K192041 · G21, S.R.L. · Oct 2019
SpaceFlex Knee
K190216 · G21, S.R.L. · Jun 2019
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
K161273 · Biomet, Inc. · Jan 2017
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
K160071 · Biomet, Inc. · Jun 2016
Refobacin Bone Cement R
K150850 · Biomet, Inc. · Jul 2015
BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
K131135 · Biomet Manufacturing Corp · Jan 2014