Cleared Traditional

CALCIGEN-S BONE VOID FILER (K013790) - FDA 510(k) Clearance

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

K013790 · Biomet Orthopedics, Inc. · Orthopedic device
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Jun 2002
Decision
209d
Days
Class 2
Risk

K013790 is an FDA 510(k) clearance for the CALCIGEN-S BONE VOID FILER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 11, 2002 after a review of 209 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 Orthopedics, Inc. devices

Submission Details

510(k) Number K013790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2001
Decision Date June 11, 2002
Days to Decision 209 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 122d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MQV Filler, Bone Void, Calcium Compound

All 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K013790.
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · Synthes (Usa) · Dec 2002
WMT-TCP BONE GRAFT SUBSTITUTE
K022629 · Wrightmedicaltechnologyinc · Nov 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · Biomet, Inc. · Sep 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506 · Medtronic Sofamor Danek USA, Inc. · Mar 2002
NORIAN SRS BONE VOID FILLER
K011897 · Synthes (Usa) · Dec 2001
BSM BONE SUBSTITUTE MATERIAL
K011048 · DePuy Orthopaedics, Inc. · Nov 2001