Cleared Traditional

K221388 - NuVasive Reline Cervical System

K221388 is the FDA 510(k) clearance for NuVasive Reline Cervical System by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K221388 · Nu Vasive, Incorporated · Orthopedic device
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Sep 2022
Decision
119d
Days
Class 2
Risk

K221388 is an FDA 510(k) clearance for the NuVasive Reline Cervical System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on September 9, 2022 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - 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 K221388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2022
Decision Date September 09, 2022
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKG Posterior Cervical Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of 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 - NKG Posterior Cervical Screw System

All 95
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K221388.
INFINITY OCT System
K223764 · Medtronic Sofamor Danek USA, Inc. · Jan 2023
COSY Cervicothoracic Occipital Rod-Screw System
K220658 · Signus Medizintechnik GmbH · Nov 2022
Black Diamond™ POCT Spinal System
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Ennovate Cervical Spinal and Occiput System
K213871 · Aesculap Implant Systems, LLC · Jul 2022
M.U.S.T. MINI Posterior Cervical Screws System Extension
K220570 · Medacta International S.A. · Apr 2022
Infinity™ OCT System and PASS OCT Spinal System
K220810 · Medicrea International · Apr 2022