QRR · Class II · 21 CFR 888.3046

FDA Product Code QRR: Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside

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.

Leading manufacturers include Bonesupport AB.

2
Total
1
Cleared
158d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Filler, Bone Void, Calcium Compound Containing Single Approved Aminoglycoside Devices (Product Code QRR)

2 devices
1–2 of 2
Cleared Mar 13, 2024
CERAMENT G
K234008
Bonesupport AB
Orthopedic · 85d
Not Cleared May 17, 2022
CERAMENT G
DEN210044
Bonesupport AB
Orthopedic · 231d

About Product Code QRR - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QRR since 2022, with 1 receiving FDA clearance (average review time: 158 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QRR devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →