Cleared Traditional

FIBERGRAFT BG Matrix Bone Graft Substitute (K180080) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180080 · Prosidyan, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
86d
Days
Class 2
Risk

K180080 is an FDA 510(k) clearance for the FIBERGRAFT BG Matrix 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 April 6, 2018 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prosidyan, Inc. devices

Submission Details

510(k) Number K180080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2018
Decision Date April 06, 2018
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 201
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K180080.
DSM Biomedical Calcium Phosphate Cement with Microspheres
K173572 · Kensey Nash Corporation Dba Dsm Biomedical · May 2018
Rafugen DBM
K180121 · Cellumed Co., Ltd. · Apr 2018
NovoGro
K173525 · Osteonovus, Inc. · Apr 2018
DSM Biomedical Calcium Phosphate Cement
K173362 · Kensey Nash Corporation Dba Dsm Biomedical · Apr 2018
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
K171568 · Hans Biomed Corporation · Feb 2018
Bicera Resorbable Bone Substitute
K172237 · Wiltrom Corporation Limited · Feb 2018