Cleared Traditional

K173047 - The Solstice OCT System

K173047 is the FDA 510(k) clearance for The Solstice OCT System by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K173047 · Life Spine, Inc. · Orthopedic device
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Feb 2018
Decision
126d
Days
Class 2
Risk

K173047 is an FDA 510(k) clearance for the The Solstice OCT System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on February 1, 2018 after a review of 126 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 Life Spine, Inc. devices

Submission Details

510(k) Number K173047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2017
Decision Date February 01, 2018
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 96
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K173047.
VERTEX™ Reconstruction System
K180851 · Medtronic Sofamor Danek USA, Inc. · Apr 2018
Reform® POCT System
K172495 · Precision Spine, Inc. · Apr 2018
NuVasive® VuePoint® II OCT System
K180198 · Nu Vasive, Incorporated · Mar 2018
Centurion POCT System
K180025 · Orthofix, Inc. · Jan 2018
Proficient® Posterior Cervical Spine System
K172594 · Spine Wave, Inc. · Dec 2017
INFINITY™ OCT System
K163375 · Medtronic Sofamor Danek USA, Inc. · Aug 2017