Cleared Traditional

K063857 - SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE...

K063857 is the FDA 510(k) clearance for SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code MBB) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K063857 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
60d
Days
Class 2
Risk

K063857 is an FDA 510(k) clearance for the SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT. Classified as Bone Cement, Antibiotic (product code MBB), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on February 26, 2007 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K063857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2006
Decision Date February 26, 2007
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 K063857.
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
DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
K061144 · DePuy Orthopaedics, Inc. · Jun 2006
DEPUY CMW 1 GENTAMICIN BONE CEMENT
K053002 · DePuy Orthopaedics, Inc. · Nov 2005