Cleared Special

K112108 - ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

K112108 is the FDA 510(k) clearance for ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM by Spineart. It is a Class 2 Orthopedic device (product code MNI) cleared through the Special 510(k) pathway after a 28-day FDA review.

K112108 · Spineart · Orthopedic device
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Aug 2011
Decision
28d
Days
Class 2
Risk

K112108 is an FDA 510(k) clearance for the ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on August 19, 2011 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spineart devices

Submission Details

510(k) Number K112108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2011
Decision Date August 19, 2011
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 159
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K112108.
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · K2m, Inc. · Dec 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037 · K2m, Inc. · Oct 2011
CAPSURE(R) PS SYSTEM
K111913 · Spine Wave, Inc. · Aug 2011
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K111127 · Spineart · Aug 2011
MESA SPINAL SYSTEM (KEYSTONE RODS)
K110991 · K2m, Inc. · Aug 2011
VENUS CERVICAL SPINAL FIXATION SYSTEM
K103414 · L & K Biomed Co., Ltd. · Jul 2011