Cleared Special

K130953 - NEOTIS (FDA 510(k) Clearance)

Also includes:
NEOTIS 50

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K130953 · Sbm Sciences For Bio Materials · Orthopedic device
Download Printable Device Report (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.

View all Sbm Sciences For Bio Materials devices

Submission Details

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
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Modification to existing cleared device.

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 489
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K130953.
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
K261008 · Stryker Spine · Apr 2026
Adaptos®Fuse Bone Graft
K253524 · Biomendex OY · Feb 2026
FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute
K253147 · Prosidyan, Inc. · Oct 2025
Mg OSTEOINJECT™
K251522 · Bone Solutions, Inc. · Oct 2025
Allomatrix (Allomatrix Injectable Putty
K252085 · Wright Medical Technology, Inc. (Stryker Corporation) · Sep 2025
Device 300423 Granules
K251556 · Geistlich Pharma AG · Jul 2025