Cleared Traditional

K160071 - StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

K160071 is an FDA 510(k) clearance for StageOne Disposable Cement Spacer Molds..., 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 155-day FDA review.

K160071 · Biomet, Inc. · Orthopedic device
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Jun 2016
Decision
155d
Days
Class 2
Risk

K160071 is an FDA 510(k) clearance for the StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis. 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 June 16, 2016 after a review of 155 days - an extended review cycle.

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 - K160071

510(k) Number K160071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2016
Decision Date June 16, 2016
Days to Decision 155 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
33d slower than avg
Panel avg: 122d · This submission: 155d
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 K160071.
SpaceFlex Knee
K190216 · G21, S.R.L. · Jun 2019
StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis
K161273 · Biomet, Inc. · Jan 2017
StageOne Select Cement Spacer Molds for Temporary Hip Replacement
K161166 · Biomet, Inc. · Sep 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
SMARTSET GMV GENTAMICIN BONE CEMENT
K081163 · DePuy Orthopaedics, Inc. · May 2008