Cleared Special

K190071 - Perla® Posterior Cervico-Thoracic Fixation System

K190071 is an FDA 510(k) clearance for Perla Posterior Cervico-Thoracic Fixati..., manufactured by Spineart. The device is a Class 2 Orthopedic device with product code NKG cleared through the Special 510(k) pathway after a 41-day FDA review.

K190071 · Spineart · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
41d
Days
Class 2
Risk

K190071 is an FDA 510(k) clearance for the Perla® Posterior Cervico-Thoracic Fixation System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Spineart (Plan Les Ouates, CH). The FDA issued a Cleared decision on February 25, 2019 after a review of 41 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K190071

510(k) Number K190071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2019
Decision Date February 25, 2019
Days to Decision 41 days
Submission Type Special
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
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Modification to existing cleared device.

NKG Device Classification - Class 2, Special Controls

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 118
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K190071.
Solanas® Posterior OCT Fixation System
K191185 · Alphatec Spine · Jun 2019
Connector System
K190751 · Orthofix, Inc. · May 2019
M.U.S.T. MINI Posterior Cervical Screws System
K190631 · Medacta International S.A. · Apr 2019
M.U.S.T. Mini Extension
K182837 · Medacta International S.A. · Jan 2019
ANAX™ OCT Spinal System
K183383 · U&I Corporation · Dec 2018
YUKON OCT Spinal System
K182182 · K2m · Nov 2018
K190071 · Perla® Posterior Cervico-Thoracic Fixation System
Download PDF FDA Summary Spineart