Cleared Traditional

K201648 - Sterispine PS

K201648 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 Traditional 510(k) pathway after a 42-day FDA review.

K201648 · Safe Orthopaedics · Orthopedic device
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Jul 2020
Decision
42d
Days
Class 2
Risk

K201648 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 July 30, 2020 after a review of 42 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Safe Orthopaedics devices

Submission Details

510(k) Number K201648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2020
Decision Date July 30, 2020
Days to Decision 42 days
Submission Type Traditional
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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 614
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K201648.
ORION Spinal System
K190600 · Orion Biotech, Inc. · Aug 2020
Mega Plus MIS Spine System
K200981 · Bk Meditech, Co., Ltd. · Aug 2020
CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System
K201926 · CarboFix Orthopedics , Ltd. · Aug 2020
Pedicle Screw System
K201751 · Black Box Medical, LLC · Jul 2020
True Tulip System, True M.I.S. System
K201780 · Innovative Surgical Designs, Inc. · Jul 2020
Spinal Fixation System
K190408 · Shangdong Kangsheng Medical Devices Co., Ltd. · Jun 2020