Cleared Special

K103816 - COHESION BONE CEMENT

K103816 is an FDA 510(k) clearance for COHESION BONE CEMENT, manufactured by Teknimed Sas. The device is a Class 2 Orthopedic device with product code NDN cleared through the Special 510(k) pathway after a 37-day FDA review.

K103816 · Teknimed Sas · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
37d
Days
Class 2
Risk

K103816 is an FDA 510(k) clearance for the COHESION BONE CEMENT. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Teknimed Sas (Round Rock, US). The FDA issued a Cleared decision on February 4, 2011 after a review of 37 days - a notably fast clearance 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. 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 - K103816

510(k) Number K103816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2010
Decision Date February 04, 2011
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
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 K103816.
IVAS 2-10MM (10 GUAGE) BALLON CATHETER
K103807 · Stryker Corporation · Jun 2011
KYPHON XPEDE BONE CEMENT
K102397 · Medtronic · Feb 2011
ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K110183 · Arthrocare Corp. · Feb 2011
AVAMAX VERTEBRAL BALLOON
K103064 · Care Fusion · Jan 2011
F20
K103433 · Teknimed, S.A. · Jan 2011
PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K100479 · Arthrocare Corp. · Sep 2010
K103816 · COHESION BONE CEMENT
Download PDF FDA Summary Teknimed Sas