Cleared Special

K131802 - EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM

K131802 is an FDA 510(k) clearance for EXPEDIUM, manufactured by Depuy Spine, A Johnson & Johnson Company. The device is a Class 2 Orthopedic device with product code OSH cleared through the Special 510(k) pathway after a 85-day FDA review.

K131802 · Depuy Spine, A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
85d
Days
Class 2
Risk

K131802 is an FDA 510(k) clearance for the EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM. Classified as Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (product code OSH), Class II - Special Controls.

Submitted by Depuy Spine, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on September 12, 2013 after a review of 85 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 - K131802

510(k) Number K131802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2013
Decision Date September 12, 2013
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

OSH Device Classification - Class 2, Special Controls

Product Code OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis.
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 - OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

All 18
Devices cleared under the same product code (OSH) and FDA review panel - the closest regulatory comparables to K131802.
PASS LP SPINAL SYSTEM
K132574 · Medicrea International · Nov 2013
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K132303 · Implanet, S.A. · Oct 2013
PASS LP SPINAL SYSTEM
K132575 · Medicrea International · Oct 2013
POLARIS SPINAL SYSTEM
K131615 · Biomet Spine (Aka Ebi, LLC) · Sep 2013
RANGE SPINAL SYSTEM
K131784 · K2m, Inc. · Aug 2013
CD HORIZON SPINAL SYSTEM
K131321 · Medtronic Sofamor Danek USA · Jun 2013