Cleared Traditional

K143533 - FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE

K143533 is an FDA 510(k) clearance for FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE, manufactured by Prosidyan, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K143533 · Prosidyan, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
103d
Days
Class 2
Risk

K143533 is an FDA 510(k) clearance for the FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Prosidyan, Inc. (Warren, US). The FDA issued a Cleared decision on March 25, 2015 after a review of 103 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 Prosidyan, Inc. devices

FDA 510(k) Submission Details - K143533

510(k) Number K143533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2014
Decision Date March 25, 2015
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 Consultant

Hogan Lovells US LLP
JANICE M HOGAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 468
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K143533.
OsteoSelect PLUS Demineralized Bone Matrix Putty
K150621 · Bacterin International, Inc. · Aug 2015
MASTERGRAFT Contain
K151172 · Medtronic Sofamor Danek USA, Inc. · Aug 2015
BONGOLD BONE GRAFT MATERIAL
K141725 · Beijing Allgens Medical Science & Technology Co, L · Jul 2015
SORRENTO BONE GRAFT SUBSTITUTE
K141429 · Haider Biologics, LLC · Feb 2015
CARRICELL
K132868 · Etex Corporation · Feb 2015
NUROS BONE GRAFT SUBSTITUTE
K140913 · Oriental Resources Development Limited · Feb 2015