Cleared Special

K051716 - VERTEBRON PSS PEDICLE SCREW SYSTEM

K051716 is an FDA 510(k) clearance for VERTEBRON PSS PEDICLE SCREW SYSTEM, manufactured by Vertebron, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 72-day FDA review.

K051716 · Vertebron, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
72d
Days
Class 2
Risk

K051716 is an FDA 510(k) clearance for the VERTEBRON PSS PEDICLE SCREW SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Vertebron, Inc. (Stratford, US). The FDA issued a Cleared decision on September 7, 2005 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K051716

510(k) Number K051716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2005
Decision Date September 07, 2005
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 421
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K051716.
VERTEX RECONSTRUCTION SYSTEM
K052402 · Medtronic Sofamor Danek · Sep 2005
NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX
K052247 · Abbott Spine, Inc. · Sep 2005
MODIFICATION TO XIA SPINAL SYSTEM
K052181 · Stryker Spine · Sep 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180 · Medtronic Sofamor Danek · Aug 2005
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
K051973 · Stryker Spine · Aug 2005
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
K052069 · Globus Medical, Inc. · Aug 2005
K051716 · VERTEBRON PSS PEDICLE SCREW SYSTEM
Download PDF FDA Summary Vertebron, Inc.