Cleared Special

K140802 - STERISPINE PS

K140802 is the FDA 510(k) clearance for STERISPINE PS by Safe Orthopaedics. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 65-day FDA review.

K140802 · Safe Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
65d
Days
Class 2
Risk

K140802 is an FDA 510(k) clearance for the STERISPINE PS. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Safe Orthopaedics (Eragny Sur Oise, FR). The FDA issued a Cleared decision on June 4, 2014 after a review of 65 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.

View all Safe Orthopaedics devices

Submission Details

510(k) Number K140802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date June 04, 2014
Days to Decision 65 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 122d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 615
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K140802.
K2M MODULAR HOOKS
K133402 · K2m, Inc. · Jul 2014
CD HORIZON SPINAL SYSTEM
K141605 · Medtronic Sofamor Danek USA, Inc. · Jul 2014
RANGE/MESA/DENALI SPINAL SYSTEM
K140765 · K2m, Inc. · Jul 2014
RANGE SPINAL SYSTEM
K141147 · K2m, Inc. · Jun 2014
FORTRESS PEDICLE SCREW SYSTEM
K140010 · Spineology, Inc. · Apr 2014
CD HORIZON SPINAL SYSTEM
K140449 · Medtronic Sofamor Danek, Inc. · Mar 2014