Cleared Traditional

K133374 - STREAMLINE OCT OCCIPITO-CERVICO-THORACI...

K133374 is the FDA 510(k) clearance for STREAMLINE OCT OCCIPITO-CERVICO-THORACI... by Pioneer Surgical Technology, Inc. (Rti Surgical, I. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K133374 · Pioneer Surgical Technology, Inc. (Rti Surgical, I · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
138d
Days
Class 2
Risk

K133374 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. (Rti Surgical, I (Marquette, US). The FDA issued a Cleared decision on March 19, 2014 after a review of 138 days - within the typical 510(k) review window.

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: 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 Pioneer Surgical Technology, Inc. (Rti Surgical, I devices

Submission Details

510(k) Number K133374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2013
Decision Date March 19, 2014
Days to Decision 138 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
16d slower than avg
Panel avg: 122d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 273
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K133374.
CASPIAN SPINAL SYSTEM
K141284 · K2m, Inc. · Jul 2014
CASPIAN OCT SPINAL SYSTEM
K133288 · K2m, Inc. · Jul 2014
VIRAGE OCT SPINAL FIXATION SYSTEM
K133556 · Zimmer Spine, Inc. · Jun 2014
CENTURION POCT SYSTEM
K131833 · Orthofix, Inc. · Jan 2014
SYNAPSE SYSTEM
K133698 · Synthes USA Products, LLC · Jan 2014
CERTEX OCT SPINAL IMPLANT SYSTEM
K133094 · X-Spine Systems, Inc. · Dec 2013