Cleared Traditional

K013755 - CONCERT RADIOPAQUE BONE CEMENT

K013755 is an FDA 510(k) clearance for CONCERT RADIOPAQUE BONE CEMENT, manufactured by Immedica, Inc.. The device is a Class 2 Orthopedic device with product code LOD cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K013755 · Immedica, Inc. · Orthopedic device
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Feb 2002
Decision
87d
Days
Class 2
Risk

K013755 is an FDA 510(k) clearance for the CONCERT RADIOPAQUE BONE CEMENT. Classified as Bone Cement (product code LOD), Class II - Special Controls.

Submitted by Immedica, Inc. (Washington, US). The FDA issued a Cleared decision on February 8, 2002 after a review of 87 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 Immedica, Inc. devices

FDA 510(k) Submission Details - K013755

510(k) Number K013755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date February 08, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOD Device Classification - Class 2, Special Controls

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 53
Devices cleared under the same product code (LOD) and FDA review panel - the closest regulatory comparables to K013755.
SMARTSET HV BONE CEMENT
K023012 · DePuy Orthopaedics, Inc. · Feb 2003
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499 · DePuy Orthopaedics, Inc. · Jul 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715 · Exactech, Inc. · Jun 2002
GENERATION 4 BONE CEMENT
K993836 · Biomet, Inc. · Dec 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · Exactech, Inc. · Feb 2001
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
K002652 · Stryker Corp. · Jan 2001