Cleared Traditional

K032286 - CALCIGEN PSI BONE GRAFT SUBSTITUTE

K032286 is an FDA 510(k) clearance for CALCIGEN PSI BONE GRAFT SUBSTITUTE, manufactured by Biomet Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K032286 · Biomet Orthopedics, Inc. · Orthopedic device
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Nov 2003
Decision
119d
Days
Class 2
Risk

K032286 is an FDA 510(k) clearance for the CALCIGEN PSI BONE GRAFT SUBSTITUTE. 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 November 20, 2003 after a review of 119 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K032286

510(k) Number K032286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2003
Decision Date November 20, 2003
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

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 448
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K032286.
EXACTECH RESORBABLE BONE PASTE
K020078 · Exactech, Inc. · Feb 2004
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
K032288 · Orthovita, Inc. · Dec 2003
CAP3 BONE SUBSTITUTE MATERIAL
K033138 · Etex Corp. · Dec 2003
VITOSS-FILLED CARTRIDGE
K032130 · Orthovita, Inc. · Nov 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K032409 · Orthovita, Inc. · Aug 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817 · Wrightmedicaltechnologyinc · Jul 2003