Cleared Special

OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML (K141930) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K141930 · Osseon, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2014
Decision
36d
Days
Class 2
Risk

K141930 is an FDA 510(k) clearance for the OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML. 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 August 21, 2014 after a review of 36 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.

View all Osseon, LLC devices

Submission Details

510(k) Number K141930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2014
Decision Date August 21, 2014
Days to Decision 36 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
86d faster than avg
Panel avg: 122d · This submission: 36d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 27
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K141930.
Kyphon Xpede Bone Cement
K163032 · Medtronic, Inc. · Feb 2017
CONCORD Plus Radiopaque Bone Cement
K162618 · Globus Medical, Inc. · Jan 2017
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
KYPH X HV-R BONE CEMENT
K093828 · Medtronic, Inc. · Aug 2010
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691 · Cook, Inc. · Nov 2005
CONCORD Radiopaque Bone Cement
K042168 · Globus Medical, Inc. · Jan 2005