Cleared Traditional

K031265 - SHIRAZ-JAVA SPINAL FIXATION SYSTEM

K031265 is an FDA 510(k) clearance for SHIRAZ-JAVA SPINAL FIXATION SYSTEM, manufactured by Spine Next SA. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K031265 · Spine Next SA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
171d
Days
Class 2
Risk

K031265 is an FDA 510(k) clearance for the SHIRAZ-JAVA SPINAL FIXATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spine Next SA (Queenstown, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 171 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 Spine Next SA devices

FDA 510(k) Submission Details - K031265

510(k) Number K031265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2003
Decision Date October 09, 2003
Days to Decision 171 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
49d slower than avg
Panel avg: 122d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 232
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K031265.
NUVASIVE SPINAL SYSTEM
K033546 · Nuvasive, Inc. · Apr 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · Medtronic Sofamor Danek, Inc. · Feb 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K033322 · Medtronic Sofamor Danek · Dec 2003
ORIA CLARIS
K023378 · Ortho Tec, LLC · Jun 2003
EBI P148 SPINAL FIXATION SYSTEM
K031423 · Ebi, L.P. · Jun 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · Blackstone Medical, Inc. · Jun 2003