Cleared Special

K123521 - RELIANCE SPINAL SCREW SYSTEM

K123521 is an FDA 510(k) clearance for RELIANCE SPINAL SCREW SYSTEM, manufactured by Reliance Medical Systems, LLC. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 84-day FDA review.

K123521 · Reliance Medical Systems, LLC · Orthopedic device
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Feb 2013
Decision
84d
Days
Class 2
Risk

K123521 is an FDA 510(k) clearance for the RELIANCE SPINAL SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on February 7, 2013 after a review of 84 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 Reliance Medical Systems, LLC devices

FDA 510(k) Submission Details - K123521

510(k) Number K123521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2012
Decision Date February 07, 2013
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

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 249
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K123521.
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT
K130302 · Spinevision S.A. · Jul 2013
REFORM PEDICLE SCREW SYSTEM
K131343 · Spinal USA · Jul 2013
REFORM PEDICLE SCREW SYSTEM
K130279 · Spinal USA · Jun 2013
S-LOK PSS SYSTEM
K122931 · Spinal USA · Nov 2012
CERTEX SPINAL IMPLANT SYSTEM
K122163 · X-Spine Systems, Inc. · Oct 2012
TOWERLOX PEDICLE SCREW SYSTEM
K122332 · Captiva Spine · Oct 2012