Cleared Traditional

K170306 - FIBERGRAFT BG Putty Bone Graft Substitute

K170306 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 113-day FDA review.

K170306 · Prosidyan, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2017
Decision
113d
Days
Class 2
Risk

K170306 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 May 24, 2017 after a review of 113 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 - K170306

510(k) Number K170306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2017
Decision Date May 24, 2017
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
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 K170306.
MagnetOs Putty
K171563 · Kuros Biosciences B.V · Aug 2017
FIBERGRAFT BG Matrix Bone Graft Substitute
K171284 · Prosidyan, Inc. · Jun 2017
ReBOSSIS85
K170620 · Orthorebirth Co., Ltd. · Jun 2017
Vitoss Bioactive (BA) Injectable
K163621 · Orthovita, Inc. · May 2017
NovoGro
K162087 · Osteonovus, Inc. · Apr 2017
MagnetOs
K161859 · Xpand Biotechnology BV · Feb 2017