Cleared Special

K222105 - RESPONSE 5.5/6.0 Cannulated Screw System

K222105 is an FDA 510(k) clearance for RESPONSE 5.5/6.0 Cannulated Screw System, manufactured by OrthoPediatrics Corp.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 248-day FDA review.

K222105 · OrthoPediatrics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
248d
Days
Class 2
Risk

K222105 is an FDA 510(k) clearance for the RESPONSE 5.5/6.0 Cannulated Screw 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, 2023 after a review of 248 days - an extended review 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. Standard predicate reliance. 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 - K222105

510(k) Number K222105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2022
Decision Date March 23, 2023
Days to Decision 248 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
126d slower than avg
Panel avg: 122d · This submission: 248d
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 914
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K222105.
PressON Spinal Fixation System
K223529 · Nexus Spine, LLC · May 2023
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Altus Spine Monaco Pedicle Screw System
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Swedge™ Pedicle Screw Fixation System
K230482 · Spinal Resources, Inc. · Mar 2023
LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System
K230245 · L & K Biomed Co., Ltd. · Feb 2023
G Surgical Marksman Spinal Deformity System
K230063 · G Surgical, LLC · Feb 2023
K222105 · RESPONSE 5.5/6.0 Cannulated Screw System
Download PDF FDA Summary OrthoPediatrics Corp.