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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K080873.
INFLATABLE BONE TAMP
K090211 · Cardinal Health, Inc. · Jul 2009
CORTOSS BONE AUGMENTATION MATERIAL
K080108 · Orthovita, Inc. · Jun 2009
BONOS INJECT
K090460 · Aap Biomaterials GmbH · Apr 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
MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K071927 · Depuy Spine, A Johnson & Johnson Company · Nov 2007
K080873 · OPACITY + BONE CEMENT
Download PDF FDA Summary Teknimed, S.A.