Cleared Special

K140937 - OSSEOFLEX SB

K140937 is an FDA 510(k) clearance for OSSEOFLEX SB, manufactured by Osseon, LLC. The device is a Class 2 Orthopedic device with product code NDN cleared through the Special 510(k) pathway after a 69-day FDA review.

K140937 · Osseon, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
69d
Days
Class 2
Risk

K140937 is an FDA 510(k) clearance for the OSSEOFLEX SB. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Osseon, LLC (Santa Rosa, US). The FDA issued a Cleared decision on June 19, 2014 after a review of 69 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 - K140937

510(k) Number K140937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2014
Decision Date June 19, 2014
Days to Decision 69 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
53d faster than avg
Panel avg: 122d · This submission: 69d
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 K140937.
ZVPLASTY
K141419 · Zavation, LLC · Sep 2014
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
K141930 · Osseon, LLC · Aug 2014
KIVA VCF TREATMENT SYSTEM
K141141 · Benvenue Medical, Inc. · Aug 2014
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
K132620 · Pan Medical , Ltd. · Apr 2014
MEDINAUT KYPHOPLASTY SYSTEM
K133669 · Imedicom · Apr 2014
KIVA VCF TREATMENT SYSTEM
K132817 · Benvenue Medical, Inc. · Jan 2014