Cleared Traditional

K102392 - MICROFUSE PUTTY AND MICROFUSE ST MIS

K102392 is an FDA 510(k) clearance for MICROFUSE PUTTY AND MICROFUSE ST MIS, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K102392 · Globus Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2010
Decision
121d
Days
Class 2
Risk

K102392 is an FDA 510(k) clearance for the MICROFUSE PUTTY AND MICROFUSE ST MIS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on December 22, 2010 after a review of 121 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 Globus Medical, Inc. devices

FDA 510(k) Submission Details - K102392

510(k) Number K102392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2010
Decision Date December 22, 2010
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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 442
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K102392.
DBX DEMINERALIZED BONE MATRIX PUTTY
K103795 · Musculoskeletal Transplant Foundation · Apr 2011
VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE
K103173 · Orthovita, Inc. · Feb 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722 · Synthes USA Products, LLC · Jan 2011
FM-02 BONE GRAFT SUBSTITUTE
K102545 · Orthovita, Inc. · Oct 2010
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
K101860 · Novabone Products, LLC · Sep 2010
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN
K101557 · Etex Corp. · Jul 2010