Cleared Traditional

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis (K160071) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 17
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
SMARTSET GMV GENTAMICIN BONE CEMENT
K081163 · DePuy Orthopaedics, Inc. · May 2008
SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
K063857 · Howmedica Osteonics Corp. · Feb 2007