Cleared Traditional

K121725 - PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM

K121725 is an FDA 510(k) clearance for PIONEER POSTERIOR OCCIPITO-CERVICO-THOR..., manufactured by Pioneer Surgical Technology, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K121725 · Pioneer Surgical Technology, Inc. · Orthopedic device
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Nov 2012
Decision
148d
Days
Class 2
Risk

K121725 is an FDA 510(k) clearance for the PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on November 7, 2012 after a review of 148 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. devices

FDA 510(k) Submission Details - K121725

510(k) Number K121725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2012
Decision Date November 07, 2012
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
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 384
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K121725.
STABILINK MIS SPINAL FIXATION SYSTEM
K123093 · Southern Spine, LLC · Dec 2012
VERTEX RECONSTRUCTION SYSTEM
K123568 · Medtronic Sofamor Danek USA, Inc. · Dec 2012
VERTIFLEX SPINOUS PROCESS FIXATION PLATE
K122509 · Vertiflex, Inc. · Dec 2012
RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM
K122292 · Reliance Medical Systems, LLC · Oct 2012
SOLSTICE CROSS CONNECTOR
K120998 · Life Spine · Oct 2012
NEXTGEN ALTIUS OCT SYSTEM
K122378 · Biomet Spine (Aka Ebi, LLC) · Sep 2012