Cleared Traditional

K131785 - PAGODA PEDICLE SCREW SYSTEM

K131785 is the FDA 510(k) clearance for PAGODA PEDICLE SCREW SYSTEM by Ortho Development Corp.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K131785 · Ortho Development Corp. · Orthopedic device
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Aug 2013
Decision
63d
Days
Class 2
Risk

K131785 is an FDA 510(k) clearance for the PAGODA PEDICLE SCREW SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Ortho Development Corp. (Draper, US). The FDA issued a Cleared decision on August 20, 2013 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Ortho Development Corp. devices

Submission Details

510(k) Number K131785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2013
Decision Date August 20, 2013
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K131785.
NAUTILUS SPINAL SYSTEM
K132760 · Life Spine, Inc. · Oct 2013
TIGER SPINE SYSTEM
K131250 · Corelink, LLC · Sep 2013
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM
K131980 · Zimmer Spine, Inc. · Sep 2013
FIREBIRD SPINAL FIXATION SYSTEM
K130932 · Orthofix, Inc. · Aug 2013
EXPEDIUM SPINE SYSTEM
K130877 · Medos International SARL · Jun 2013
SOLANAS POSTERIOR STABILIZATION SYSTEM
K131119 · Alphatec Spine, Inc. · May 2013