Cleared Traditional

K131615 - POLARIS SPINAL SYSTEM

K131615 is an FDA 510(k) clearance for POLARIS SPINAL SYSTEM, manufactured by Biomet Spine (Aka Ebi, LLC). The device is a Class 2 Orthopedic device with product code OSH cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K131615 · Biomet Spine (Aka Ebi, LLC) · Orthopedic device
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Sep 2013
Decision
93d
Days
Class 2
Risk

K131615 is an FDA 510(k) clearance for the POLARIS SPINAL SYSTEM. Classified as Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (product code OSH), Class II - Special Controls.

Submitted by Biomet Spine (Aka Ebi, LLC) (Parsippany, US). The FDA issued a Cleared decision on September 4, 2013 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet Spine (Aka Ebi, LLC) devices

FDA 510(k) Submission Details - K131615

510(k) Number K131615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2013
Decision Date September 04, 2013
Days to Decision 93 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 12
Devices cleared under the same product code (OSH) and FDA review panel - the closest regulatory comparables to K131615.
OLYMPIC Posterior Spinal Fixation System
K153446 · Astura Medical · Apr 2016
CD HORIZON SPINAL SYSTEM
K140276 · Medtronic Sofamor Danek · Mar 2014
RANGE SPINAL SYSTEM
K131784 · K2m, Inc. · Aug 2013
CREO STABILIZATION SYSTEM
K124058 · Globus Medical, Inc. · May 2013
RANGE SPINAL SYSTEM
K131030 · K2m, Inc. · May 2013
RANGE SPINAL SYSTEM, SMALL STATURE
K122877 · K2m, Inc. · May 2013