Cleared Special

K080873 - OPACITY + BONE CEMENT

K080873 is an FDA 510(k) clearance for OPACITY + BONE CEMENT, 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 150-day FDA review.

K080873 · Teknimed, S.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
150d
Days
Class 2
Risk

K080873 is an FDA 510(k) clearance for the OPACITY + BONE CEMENT. 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 August 28, 2008 after a review of 150 days - an extended review cycle.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Teknimed, S.A. devices

FDA 510(k) Submission Details - K080873

510(k) Number K080873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date August 28, 2008
Days to Decision 150 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 122d · This submission: 150d
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 57
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K080873.
VERTAPLEX HV (SINGLE PACK AND DUAL PACK)
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INFLATABLE BONE TAMP
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CORTOSS BONE AUGMENTATION MATERIAL
K080108 · Orthovita, Inc. · Jun 2009
MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
K071375 · Disc-O-Tech Medical Technologies, Ltd. · Dec 2007
STRYKER VERTAPLEX RADIOPAQUE BONE CEMENT
K072118 · Stryker Corp. · Dec 2007
AVAFLEX VERTEBRAL AUGMENTATION NEEDLE
K072133 · Cardinal Health, Inc. · Nov 2007