Cleared Traditional

K160466 - Response 5.5 Spine System

K160466 is an FDA 510(k) clearance for Response 5.5 Spine System, manufactured by OrthoPediatrics Corp.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K160466 · OrthoPediatrics Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2016
Decision
33d
Days
Class 2
Risk

K160466 is an FDA 510(k) clearance for the Response 5.5 Spine System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by OrthoPediatrics Corp. (Warsaw, US). The FDA issued a Cleared decision on March 23, 2016 after a review of 33 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 OrthoPediatrics Corp. devices

FDA 510(k) Submission Details - K160466

510(k) Number K160466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2016
Decision Date March 23, 2016
Days to Decision 33 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
89d faster than avg
Panel avg: 122d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 888
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K160466.
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K153442 · Medtronic Sofamor Danek USA, Inc. · Feb 2016