Cleared Traditional

XIA? 4.5 Spinal System, XIA? 4.5 Cortical Trajectory, XIA? 3 Spinal System, Serrato? Spinal System, XIA? Growth Rod Conversion Set, XIA? II Spinal System, XIA? Precision System, XIA? Anterior, Diapason? Spinal System, Opus? Spinal System, Radius? Spinal System, Mantis? Spinal System, Mantis? Redux, Trio? & Trio+ Spinal Fixation System, ES2? Spinal System, ES2? Augmentable Spinal System, Oasys? Occipito-Cervico-Thoracic System, Nile? Proximal Fixation Spinal System, Nile? Alternative Fi

K222684 · Stryker Spine · Orthopedic

Jun 2023

Decision

275d

Days

Class 2

Risk

About This 510(k) Submission

K222684 is an FDA 510(k) clearance for the XIA? 4.5 Spinal System, XIA? 4.5 Cortical Trajectory, XIA? 3 Spinal System, Serrato? Spinal System, XIA? Growth Rod Conversion Set, XIA? II Spinal System, XIA? Precision System, XIA? Anterior, Diapason? Spinal System, Opus? Spinal System, Radius? Spinal System, Mantis? Spinal System, Mantis? Redux, Trio? & Trio+ Spinal Fixation System, ES2? Spinal System, ES2? Augmentable Spinal System, Oasys? Occipito-Cervico-Thoracic System, Nile? Proximal Fixation Spinal System, Nile? Alternative Fi, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on June 8, 2023, 275 days after receiving the submission on September 6, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K222684 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2022
Decision Date	June 08, 2023
Days to Decision	275 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — 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.