Cleared Traditional

K131135 - BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS

K131135 is an FDA 510(k) clearance for BIOMET STAGE ONE DISPOSABLE CEMENT SPAC..., manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code MBB cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K131135 · Biomet Manufacturing Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
275d
Days
Class 2
Risk

K131135 is an FDA 510(k) clearance for the BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER P.... Classified as Bone Cement, Antibiotic (product code MBB), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 275 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 Manufacturing Corp devices

FDA 510(k) Submission Details - K131135

510(k) Number K131135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2013
Decision Date January 22, 2014
Days to Decision 275 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
153d slower than avg
Panel avg: 122d · This submission: 275d
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 K131135.
StageOne Select Cement Spacer Molds for Temporary Hip Replacement
K161166 · Biomet, Inc. · Sep 2016
StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis
K160071 · Biomet, Inc. · Jun 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
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
K061144 · DePuy Orthopaedics, Inc. · Jun 2006