Cleared Traditional

K031455 - CONKLUSION PEDICLE SCREW SYSTEM

K031455 is an FDA 510(k) clearance for CONKLUSION PEDICLE SCREW SYSTEM, manufactured by Signus Medical, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K031455 · Signus Medical, LLC · Orthopedic device
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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

FDA 510(k) Submission Details - K031455

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.

MNI Device Classification - Class 2, Special Controls

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 206
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K031455.
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · Medtronic Sofamor Danek, Inc. · Dec 2003
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K030958 · Ortho Tec, LLC · Nov 2003
DYNALOK CLASSIC SPINAL SYSTEM
K033271 · Medtronic Sofamor Danek · Nov 2003
TSRH SPINAL SYSTEM
K031967 · Medtronic Sofamor Danek, Inc. · Sep 2003
TSRH SPINAL SYSTEM
K032578 · Medtronic Sofamor Danek, Inc. · Sep 2003
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
K031985 · Spinal Concepts, Inc. · Sep 2003