Cleared Traditional

K140913 - NUROS BONE GRAFT SUBSTITUTE

K140913 is an FDA 510(k) clearance for NUROS BONE GRAFT SUBSTITUTE, manufactured by Oriental Resources Development Limited. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K140913 · Oriental Resources Development Limited · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
313d
Days
Class 2
Risk

K140913 is an FDA 510(k) clearance for the NUROS BONE GRAFT SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Oriental Resources Development Limited (New Taipei City, TW). The FDA issued a Cleared decision on February 17, 2015 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K140913

510(k) Number K140913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2014
Decision Date February 17, 2015
Days to Decision 313 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
191d slower than avg
Panel avg: 122d · This submission: 313d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K140913.
FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE
K143533 · Prosidyan, Inc. · Mar 2015
SORRENTO BONE GRAFT SUBSTITUTE
K141429 · Haider Biologics, LLC · Feb 2015
CARRICELL
K132868 · Etex Corporation · Feb 2015
NANOBONE / GRANULATE
K141189 · Artoss GmbH · Jan 2015
STIMULAN KIT, STIMULAN RAPID CURE
K141830 · Biocomposites, Ltd. · Jan 2015
NANOFUSE DBM
K142104 · Nanotherapeutics, Inc. · Jan 2015