Cleared Traditional

K232566 - NewPort Spinal System

Also marketed or referenced as:
Daytona Small Stature Spinal System Malibu Spinal System Mariner Pedicle Screw Systems: Mariner Outrigger Revision System Mariner MIS Pedicle Screw System Mariner Deformity System Mariner RDX System

K232566 is the FDA 510(k) clearance for NewPort Spinal System by SeaSpine Orthopedics Corporation. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K232566 · SeaSpine Orthopedics Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
239d
Days
Class 2
Risk

K232566 is an FDA 510(k) clearance for the NewPort Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on April 19, 2024 after a review of 239 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all SeaSpine Orthopedics Corporation devices

Submission Details

510(k) Number K232566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2023
Decision Date April 19, 2024
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K232566.
POWEReam Xia/Serrato
K240526 · Stryker Instruments · Apr 2024
Erisma® Deformity Spinal System
K240872 · Clariance · Apr 2024
CarboClear® Hybrid Pedicle Screw System
K240846 · CarboFix Orthopedics , Ltd. · Apr 2024
G Surgical Marksman MIS System
K240737 · G Surgical, LLC · Apr 2024
AnyPlus II Spinal Fixation System
K240350 · GS Medical Co., Ltd. · Apr 2024
CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
K233951 · Medtronic Sofamor Danek USA, Inc. · Mar 2024