Not Cleared Direct

DEN210044 - CERAMENT G (FDA 510(k) Clearance)

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

DEN210044 · Bonesupport AB · Orthopedic device
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May 2022
Decision
231d
Days
Class 2
Risk

DEN210044 is an FDA 510(k) submission (not cleared) for the CERAMENT G. Classified as Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside (product code QRR), Class II - Special Controls.

Submitted by Bonesupport AB (Lund, SE). The FDA issued a Not Cleared (DENG) decision on May 17, 2022 after a review of 231 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3046 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Orthopedic review framework.

View all Bonesupport AB devices

Submission Details

510(k) Number DEN210044 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received September 28, 2021
Decision Date May 17, 2022
Days to Decision 231 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 122d · This submission: 231d
Pathway characteristics

Device Classification

Product Code QRR Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3046
Definition A Resorbable Calcium Salt Bone Void Filler Containing A Single Approved Aminoglycoside Antibacterial Is A Resorbable Implant Intended To Fill Bony Defects Of The Extremities Where There Is An Increased Risk Of Infection. It Is Intended To Resorb Over Time And Be Replaced By New Bone. The Product Is Intended For Reduction Of Recurrence Of Chronic Osteomyelitis Of Long Bones. It Is Not Intended To Treat Infection.
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 - QRR Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

Devices cleared under the same product code (QRR) and FDA review panel - the closest regulatory comparables to DEN210044.
CERAMENT G
K234008 · Bonesupport AB · Mar 2024