Cleared Special

K040669 - CERAFORM BONE VOID FILLER

K040669 is an FDA 510(k) clearance for CERAFORM BONE VOID FILLER, manufactured by Teknimed, S.A.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 49-day FDA review.

K040669 · Teknimed, S.A. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
49d
Days
Class 2
Risk

K040669 is an FDA 510(k) clearance for the CERAFORM BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Teknimed, S.A. (Round Rock, US). The FDA issued a Cleared decision on May 3, 2004 after a review of 49 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040669

510(k) Number K040669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2004
Decision Date May 03, 2004
Days to Decision 49 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 122d · This submission: 49d
Pathway characteristics
Modification to existing cleared device.

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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K040669.
BIOFILL BONE VOID FILLER
K040454 · Scient'X · May 2004
GENEX BONE GRAFT SUBSTITUTE
K040600 · Biocomposites, Ltd. · May 2004
EOVIA CALCIUM PHOSPHATE CERAMIC
K040514 · Ortho Tec, LLC · May 2004
CALCIGEN -NAP BONE VOID FILLER
K033611 · Biomet, Inc. · Apr 2004
OSTEOSET DBM PELLETS, MODEL 8600-48XX
K022828 · Wrightmedicaltechnologyinc · Apr 2004
CERASORB M ORTHO
K040216 · Curasan AG · Mar 2004
K040669 · CERAFORM BONE VOID FILLER
Download PDF FDA Summary Teknimed, S.A.