Cleared Traditional

K073316 - CERAMENT BONE VOID FILLER

K073316 is an FDA 510(k) clearance for CERAMENT BONE VOID FILLER, manufactured by Bonesupport AB. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K073316 · Bonesupport AB · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
207d
Days
Class 2
Risk

K073316 is an FDA 510(k) clearance for the CERAMENT BONE VOID FILLER, MODEL A0210. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Bonesupport AB (Lund, SE). The FDA issued a Cleared decision on June 20, 2008 after a review of 207 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Bonesupport AB devices

FDA 510(k) Submission Details - K073316

510(k) Number K073316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2007
Decision Date June 20, 2008
Days to Decision 207 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
85d slower than avg
Panel avg: 122d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQV Device Classification - Class 2, Special Controls

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 293
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K073316.
PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC
K081558 · Pioneer Surgical Technology · Aug 2008
PLEXUR M
K081227 · Osteotech, Inc. · Jul 2008
GENEX PUTTY
K073341 · Biocomposites, Ltd. · Jul 2008
VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
K081439 · Orthovita, Inc. · Jun 2008
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
K080009 · Novabone Products, LLC · May 2008
PLEXUR-P
K080511 · Osteotech, Inc. · Apr 2008