Cleared Traditional

CONKLUSION PEDICLE SCREW SYSTEM (K031455) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031455 · Signus Medical, LLC · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
168d
Days
Class 2
Risk

K031455 is an FDA 510(k) clearance for the CONKLUSION PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Signus Medical, LLC (Chanhassen, US). The FDA issued a Cleared decision on October 22, 2003 after a review of 168 days - an extended review 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: 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 Signus Medical, LLC devices

Submission Details

510(k) Number K031455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2003
Decision Date October 22, 2003
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNI Orthosis, Spinal Pedicle Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNI Orthosis, Spinal Pedicle Fixation

All 30
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K031455.
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K040583 · Medtronic Sofamor Danek · Mar 2004
STRYKER SPINE OASYS SYSTEM
K032394 · Howmedica Osteonics Corp. · Feb 2004
DYNALOK CLASSIC SPINAL SYSTEM
K033271 · Medtronic Sofamor Danek · Nov 2003
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
K032037 · Medtronic Sofamor Danek · Sep 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031833 · Medtronic Sofamor Danek · Sep 2003
CD HORIZON SPINAL SYSTEM
K031655 · Medtronic Sofamor Danek USA, Inc. · Jun 2003