Cleared Traditional

Solanas® Posterior OCT Fixation System (K191185) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191185 · Alphatec Spine · Orthopedic device
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Jun 2019
Decision
31d
Days
Class 2
Risk

K191185 is an FDA 510(k) clearance for the Solanas® Posterior OCT Fixation System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Alphatec Spine (Carlsnad, US). The FDA issued a Cleared decision on June 3, 2019 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alphatec Spine devices

Submission Details

510(k) Number K191185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2019
Decision Date June 03, 2019
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
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 81
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K191185.
Innovasis Gibralt Spine System
K192354 · Innovasis, Inc. · Sep 2019
NuVaisve® Reline® Cervical System
K191553 · Nu Vasive, Incorporated · Aug 2019
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
K190895 · Medos International SARL · Jul 2019
Connector System
K190751 · Orthofix, Inc. · May 2019
M.U.S.T. MINI Posterior Cervical Screws System
K190631 · Medacta International S.A. · Apr 2019
Perla® Posterior Cervico-Thoracic Fixation System
K190071 · Spineart · Feb 2019