Cleared Traditional

K180121 - Rafugen DBM (FDA 510(k) Clearance)

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

K180121 · Cellumed Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
85d
Days
Class 2
Risk

K180121 is an FDA 510(k) clearance for the Rafugen DBM. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Cellumed Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on April 11, 2018 after a review of 85 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 Cellumed Co., Ltd. devices

Submission Details

510(k) Number K180121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date April 11, 2018
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
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 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 K180121.
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