Cleared Special

K081597 - MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM

K081597 is an FDA 510(k) clearance for MODIFICATION TO VERTEBRON PSS PEDICLE S..., manufactured by Vertebron, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 26-day FDA review.

K081597 · Vertebron, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
26d
Days
Class 2
Risk

K081597 is an FDA 510(k) clearance for the MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Vertebron, Inc. (Stratford, US). The FDA issued a Cleared decision on July 2, 2008 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 - K081597

510(k) Number K081597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2008
Decision Date July 02, 2008
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

MNI Device Classification - Class 2, Special Controls

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K081597.
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
K081158 · Alphatec Spine, Inc. · Jul 2008
MYKRES SPINAL SYSTEM
K071074 · Showa Ika Kohgyo Co., Ltd. · Jul 2008
ORTHOBIOM SPINAL SYSTEM
K071668 · Paradigm Spine · Jul 2008
CONQUEST SPINAL SYSTEM
K080767 · Life Spine · May 2008
CAPSURE PS (R) SPINE SYSTEM
K081228 · Spine Wave, Inc. · May 2008
PASS SPINAL SYSTEM
K080099 · Medicrea Technologies · Apr 2008
K081597 · MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM
Download PDF FDA Summary Vertebron, Inc.