Cleared Special

K090435 - VERTECEM

K090435 is an FDA 510(k) clearance for VERTECEM, manufactured by Teknimed, S.A.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Special 510(k) pathway after a 305-day FDA review.

K090435 · Teknimed, S.A. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
305d
Days
Class 2
Risk

K090435 is an FDA 510(k) clearance for the VERTECEM. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Teknimed, S.A. (Round Rock, US). The FDA issued a Cleared decision on December 21, 2009 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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. Elevated predicate reliance 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 - K090435

510(k) Number K090435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2009
Decision Date December 21, 2009
Days to Decision 305 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
183d slower than avg
Panel avg: 122d · This submission: 305d
Pathway characteristics
Modification to existing cleared device.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
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 - NDN Cement, Bone, Vertebroplasty

All 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K090435.
AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
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K091234 · Skeltex Technologies, Inc. · Feb 2010
STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)
K090986 · Dfine, Inc. · Dec 2009
VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
K091606 · Stryker Corp. · Oct 2009
INFLATABLE BONE TAMP
K090211 · Cardinal Health, Inc. · Jul 2009
CORTOSS BONE AUGMENTATION MATERIAL
K080108 · Orthovita, Inc. · Jun 2009
K090435 · VERTECEM
Download PDF FDA Summary Teknimed, S.A.