Cleared Traditional

K131615 - POLARIS SPINAL SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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.