Cleared Traditional

K234008 - CERAMENT G (FDA 510(k) Clearance)

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

K234008 · Bonesupport AB · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
85d
Days
Class 2
Risk

K234008 is an FDA 510(k) clearance 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 Cleared decision on March 13, 2024 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3046 - 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 Bonesupport AB devices

Submission Details

510(k) Number K234008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2023
Decision Date March 13, 2024
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
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 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 K234008.
CERAMENT G
DEN210044 · Bonesupport AB · May 2022