Cleared Traditional

K130267 - ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

K130267 is an FDA 510(k) clearance for ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM, manufactured by Spineart. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K130267 · Spineart · Orthopedic device
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May 2013
Decision
116d
Days
Class 2
Risk

K130267 is an FDA 510(k) clearance for the ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on May 31, 2013 after a review of 116 days - within the typical 510(k) review window.

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 Spineart devices

FDA 510(k) Submission Details - K130267

510(k) Number K130267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2013
Decision Date May 31, 2013
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 270
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K130267.
ANAX 5.5 SPINAL SYSTEM
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OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
K131810 · Osseus Fusion Systems, LLC · Aug 2013
INTRAMEDULLARY NAIL SYSTEM
K122994 · Weigao Orthopaedic Device Co., Ltd. · Apr 2013
GSO GS1 CANNULATED SCREW SYSTEM
K123487 · Gold Standard Orthopaedics, LLC · Mar 2013
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K123164 · Spinefrontier, Inc. · Feb 2013