Cleared Traditional

K101525 - PIONEER SPINOUS PROCESS FUSION PLATE

K101525 is the FDA 510(k) clearance for PIONEER SPINOUS PROCESS FUSION PLATE by Pioneer Surgical Technology. It is a Class 2 Orthopedic device (product code KWP) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K101525 · Pioneer Surgical Technology · Orthopedic device
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Oct 2010
Decision
142d
Days
Class 2
Risk

K101525 is an FDA 510(k) clearance for the PIONEER SPINOUS PROCESS FUSION PLATE. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Pioneer Surgical Technology (West Newbury, US). The FDA issued a Cleared decision on October 22, 2010 after a review of 142 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 devices

Submission Details

510(k) Number K101525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2010
Decision Date October 22, 2010
Days to Decision 142 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
20d slower than avg
Panel avg: 122d · This submission: 142d
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 272
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K101525.
CASPIAN SPINAL SYSTEM
K103232 · K2m, Inc. · Jan 2011
AXLE INTERSPINOUS FUSION SYSTEM
K101471 · X-Spine Systems, Inc. · Nov 2010
MODIFICATION TO: OASYS SYSTEM
K101183 · Stryker Spine · Nov 2010
CASPIAN SPINAL SYSTEM
K101084 · K2m, Inc. · Oct 2010
PRIMAL OK INTERSPINOUS FUSION SYSTEM
K100354 · Osteomed LP · Aug 2010
NUVASIVE VUEPOINT OCT SYSTEM
K093319 · Nuvasive, Inc. · Jun 2010