Cleared Special

G Surgical Marksman Spinal Deformity System (K230063) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K230063 · G Surgical, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
31d
Days
Class 2
Risk

K230063 is an FDA 510(k) clearance for the G Surgical Marksman Spinal Deformity System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by G Surgical, LLC (Austin, US). The FDA issued a Cleared decision on February 9, 2023 after a review of 31 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.

View all G Surgical, LLC devices

Submission Details

510(k) Number K230063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2023
Decision Date February 09, 2023
Days to Decision 31 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K230063.
RESPONSE 5.5/6.0 Cannulated Screw System
K222105 · OrthoPediatrics Corp. · Mar 2023
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
CD Horizon Spinal System
K223494 · Medtronic · Jan 2023
NuVasive Reline System
K223181 · Nu Vasive, Incorporated · Jan 2023
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
K223565 · L & K Biomed Co., Ltd. · Dec 2022