Cleared Traditional

K223181 - NuVasive Reline System

K223181 is the FDA 510(k) clearance for NuVasive Reline System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K223181 · Nu Vasive, Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2023
Decision
92d
Days
Class 2
Risk

K223181 is an FDA 510(k) clearance for the NuVasive Reline System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on January 11, 2023 after a review of 92 days - within the typical 510(k) review window.

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 Nu Vasive, Incorporated devices

Submission Details

510(k) Number K223181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2022
Decision Date January 11, 2023
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 659
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K223181.
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
CD Horizon Spinal System
K223494 · Medtronic · Jan 2023
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
K223565 · L & K Biomed Co., Ltd. · Dec 2022
ASTRA Spine System
K223273 · Spinecraft, LLC · Dec 2022
Zavation Spinal System
K222614 · Zavation Medical Products, LLC · Dec 2022