Cleared Traditional

K093438 - PARADIGM INTERSPINOUS FUSION PLATE

K093438 is an FDA 510(k) clearance for PARADIGM INTERSPINOUS FUSION PLATE, manufactured by Paradigm Spine, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 336-day FDA review.

K093438 · Paradigm Spine, LLC · Orthopedic device
Download Printable Device Report (PDF)
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Oct 2010
Decision
336d
Days
Class 2
Risk

K093438 is an FDA 510(k) clearance for the PARADIGM INTERSPINOUS FUSION PLATE. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Paradigm Spine, LLC (Washington, US). The FDA issued a Cleared decision on October 6, 2010 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Paradigm Spine, LLC devices

FDA 510(k) Submission Details - K093438

510(k) Number K093438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2009
Decision Date October 06, 2010
Days to Decision 336 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
214d slower than avg
Panel avg: 122d · This submission: 336d
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 337
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K093438.
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MODIFICATION TO: OASYS SYSTEM
K101183 · Stryker Spine · Nov 2010
PIONEER SPINOUS PROCESS FUSION PLATE
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CASPIAN SPINAL SYSTEM
K101084 · K2m, Inc. · Oct 2010
VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
K102020 · Spinefrontier, Inc. · Sep 2010
PRIMAL OK INTERSPINOUS FUSION SYSTEM
K100354 · Osteomed LP · Aug 2010