Cleared Traditional

K053198 - SIMPLEX P SPEEDSET BONE CEMENT

K053198 is the FDA 510(k) clearance for SIMPLEX P SPEEDSET BONE CEMENT by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code LOD) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K053198 · Howmedica Osteonics Corp. · Orthopedic device
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Jan 2006
Decision
71d
Days
Class 2
Risk

K053198 is an FDA 510(k) clearance for the SIMPLEX P SPEEDSET BONE CEMENT. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on January 26, 2006 after a review of 71 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 K053198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2005
Decision Date January 26, 2006
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOD Bone Cement
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 - LOD Bone Cement

All 51
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K053198.
COBALT MV BONE CEMENT
K091608 · Biomet Manufacturing Corp · Sep 2009
SMARTSET MV BONE CEMENT
K081155 · DePuy Orthopaedics, Inc. · May 2008
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
K070015 · Biomet Manufacturing Corp · Nov 2007
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
K053445 · DePuy Orthopaedics, Inc. · Jan 2006
DEPUY CMW 1, 2 AND 3 BONE CEMENTS
K053003 · DePuy Orthopaedics, Inc. · Nov 2005
COBALT BONE CEMENT
K051496 · Biomet, Inc. · Aug 2005