Cleared Special

K170528 - Sterispine™ PS

K170528 is an FDA 510(k) clearance for Sterispine PS, manufactured by Safe Orthopaedics. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 15-day FDA review.

K170528 · Safe Orthopaedics · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
15d
Days
Class 2
Risk

K170528 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 March 9, 2017 after a review of 15 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 - K170528

510(k) Number K170528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2017
Decision Date March 09, 2017
Days to Decision 15 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
107d faster than avg
Panel avg: 122d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

NKB Device Classification - Class 2, Special Controls

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 913
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K170528.
USS System
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Revolution™ Spinal Fixation System
K163056 · Intelligent Implant Systems, LLC · Feb 2017
Erisma® LP Spinal Fixation System
K170163 · Clariance, Sas · Feb 2017
Hubble I System
K163566 · Orbbo Surgical, LLC · Feb 2017
K170528 · Sterispine™ PS
Download PDF FDA Summary Safe Orthopaedics