Cleared Traditional

K102722 - NORIAN DRILLABLE INJECT

K102722 is the FDA 510(k) clearance for NORIAN DRILLABLE INJECT by Synthes USA Products, LLC. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K102722 · Synthes USA Products, LLC · Orthopedic device
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Jan 2011
Decision
128d
Days
Class 2
Risk

K102722 is an FDA 510(k) clearance for the NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on January 27, 2011 after a review of 128 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 Synthes USA Products, LLC devices

Submission Details

510(k) Number K102722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2010
Decision Date January 27, 2011
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
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 251
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K102722.
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
K110925 · Novabone Products, LLC · Jul 2011
FORTROSS BONE VOID FILLER
K110561 · Pioneer Surgical Technology · Apr 2011
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K110368 · Novabone Products, LLC · Apr 2011
MICROFUSE PUTTY AND MICROFUSE ST MIS
K102392 · Globus Medical, Inc. · Dec 2010
NOVABONE PUTTY- BIOACTIVE SYNTHETIC BONE GRAFT
K101860 · Novabone Products, LLC · Sep 2010
SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K092608 · Collagen Matrix, Inc. · May 2010