Cleared Special

K130953 - NEOTIS

Also marketed or referenced as:
NEOTIS 50

K130953 is an FDA 510(k) clearance for NEOTIS, manufactured by Sbm Sciences For Bio Materials. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 101-day FDA review.

K130953 · Sbm Sciences For Bio Materials · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
101d
Days
Class 2
Risk

K130953 is an FDA 510(k) clearance for the NEOTIS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Sbm Sciences For Bio Materials (Lourdes, FR). The FDA issued a Cleared decision on July 15, 2013 after a review of 101 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K130953

510(k) Number K130953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2013
Decision Date July 15, 2013
Days to Decision 101 days
Submission Type Special
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
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

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 K130953.
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673 · Medtronic Sofamor Danek USA, Inc. · Oct 2013
KINEX BIOACTIVE
K130392 · Globus Medical, Inc. · Aug 2013
VIVORTE BVF LITE
K131133 · Vivorte, Inc. · Aug 2013
BIOSPHERE BIOACTIVE BONE GRAFT PUTTY
K122868 · Synergy Biomedical, LLC · Apr 2013
MASTERGRAFT STRIP
K130335 · Medtronic Sofamor Danek USA, Inc. · Apr 2013
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871 · Wrightmedicaltechnologyinc · Mar 2013
K130953 · NEOTIS
Download PDF FDA Summary Sbm Sciences For Bio …