Cleared Traditional

K081108 - MONOPOLY PEDICLE SCREW SYSTEM

K081108 is an FDA 510(k) clearance for MONOPOLY PEDICLE SCREW SYSTEM, manufactured by Signus Medical, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K081108 · Signus Medical, LLC · Orthopedic device
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Jul 2008
Decision
87d
Days
Class 2
Risk

K081108 is an FDA 510(k) clearance for the MONOPOLY 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 Signus Medical, LLC (Washington, US). The FDA issued a Cleared decision on July 14, 2008 after a review of 87 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 Signus Medical, LLC devices

FDA 510(k) Submission Details - K081108

510(k) Number K081108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2008
Decision Date July 14, 2008
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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 751
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K081108.
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · Blackstone Medical, Inc. · Sep 2008
EXPEDIUM SPINE SYSTEM
K081898 · Depuy Spine, Inc. · Sep 2008
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM
K082195 · Depuy Spine, Inc. · Sep 2008
MODIFICATION TO CORAL SPINAL SYSTEM
K081414 · Theken Spine, LLC · Jun 2008
AXIS FIXATION SYSTEM
K062254 · Medtronic Sofamor Danek, Inc. · Jun 2008
EXPEDIUM 4.5MM SPINE SYSTEM
K081252 · Depuy Spine, Inc. · May 2008