Cleared Special

K042911 - CEMENTEK LV

K042911 is an FDA 510(k) clearance for CEMENTEK LV, 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 67-day FDA review.

K042911 · Teknimed, S.A. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
67d
Days
Class 2
Risk

K042911 is an FDA 510(k) clearance for the CEMENTEK LV. 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 December 27, 2004 after a review of 67 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 - K042911

510(k) Number K042911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2004
Decision Date December 27, 2004
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
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 K042911.
ALLOGRAN-N-BONE VOID FILLER
K043514 · Biocomposites, Ltd. · Jan 2005
SYNTHES (USA) CHRONOS
K043045 · Synthes (Usa) · Jan 2005
BF+
K043347 · Ldr Spine USA · Jan 2005
POLYGRAFT BGS
K040047 · Osteobiologics, Inc. · Dec 2004
BIOPLUS
K042636 · Berkeley Advanced Biomaterials, Inc. · Dec 2004
KASIOS TCP
K042340 · Kasios Biomaterials · Nov 2004
K042911 · CEMENTEK LV
Download PDF FDA Summary Teknimed, S.A.