Cleared Traditional

K161498 - Streamline OCT Occipito-Cervico-Thoraci...

K161498 is the FDA 510(k) clearance for Streamline OCT Occipito-Cervico-Thoraci... by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K161498 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2016
Decision
82d
Days
Class 2
Risk

K161498 is an FDA 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on August 22, 2016 after a review of 82 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 Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) devices

Submission Details

510(k) Number K161498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2016
Decision Date August 22, 2016
Days to Decision 82 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 122d · This submission: 82d
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 K161498.
Proficient™ Posterior Cervical Spine System
K162639 · Spine Wave, Inc. · Feb 2017
CastleLoc-S Posterior Cervical Fixation System
K162136 · L & K Biomed Co., Ltd. · Nov 2016
QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments
K161591 · Globus Medical, Inc. · Sep 2016
PathLoc-C Posterior Cervical Fixation System
K153439 · L & K Biomed Co., Ltd. · Jul 2016
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697 · Exactech, Inc. · Jun 2016
Zimmer Virage OCT Spinal Fixation System
K153631 · Zimmer Spine, Inc. · Feb 2016