Cleared Traditional

K082002 - PROGENIX PLUS

K082002 is the FDA 510(k) clearance for PROGENIX PLUS by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K082002 · Medtronic Sofamor Danek · Orthopedic device
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Nov 2008
Decision
133d
Days
Class 2
Risk

K082002 is an FDA 510(k) clearance for the PROGENIX PLUS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on November 24, 2008 after a review of 133 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 Medtronic Sofamor Danek devices

Submission Details

510(k) Number K082002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2008
Decision Date November 24, 2008
Days to Decision 133 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
11d slower than avg
Panel avg: 122d · This submission: 133d
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 233
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K082002.
MASTERGRAFT STRIP
K082166 · Medtronic Sofamor Danek · Jun 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · Medtronic Sofamor Danek · Feb 2009
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · Globus Medical, Inc. · Dec 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · Baxter Healthcare Corp · Oct 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
K082442 · Globus Medical, Inc. · Oct 2008
HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015
K081758 · Depuy Spine, Inc. · Sep 2008