Cleared Traditional

K150254 - Streamline OCT Occipito-Cervico-Thoracic System

K150254 is an FDA 510(k) clearance for Streamline OCT Occipito-Cervico-Thoraci..., manufactured by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K150254 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
84d
Days
Class 2
Risk

K150254 is an FDA 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on April 28, 2015 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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

FDA 510(k) Submission Details - K150254

510(k) Number K150254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2015
Decision Date April 28, 2015
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 373
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K150254.
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K150753 · Stryker Corporation · Jun 2015
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K150851 · Precision Spine, Inc. · Jun 2015
Reliance Posterior Cervical-Thoracic System
K142867 · Reliance Medical Systems, LLC · Apr 2015
SOLSTICE OCT System
K142253 · Life Spine, Inc. · Apr 2015
SOLSTICE OCT System
K143249 · Life Spine, Inc. · Apr 2015
SOLSTICE OCT System
K150229 · Life Spine, Inc. · Apr 2015