Cleared Special

K110896 - RELIANCE SPINAL SCREW SYSTEM

K110896 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 296-day FDA review.

K110896 · Reliance Medical Systems, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
296d
Days
Class 2
Risk

K110896 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 January 20, 2012 after a review of 296 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110896

510(k) Number K110896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2011
Decision Date January 20, 2012
Days to Decision 296 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
174d slower than avg
Panel avg: 122d · This submission: 296d
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 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K110896.
AILERON INTERSPINOUS FIXATION SYSTEM
K113157 · Life Spine · Mar 2012
SYNTHES USS CONNECTORS
K113149 · Synthes Spine · Feb 2012
SAVANNAH TECHNOLOGIES SPINAL SYSTEM
K113755 · Savannah Technologies, LLC · Feb 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112920 · K2m, Inc. · Dec 2011
ZAVATION SPINAL SYSTEM
K112484 · Zavation, LLC · Nov 2011
PASS LP SPINAL SYSTEM
K112493 · Medicrea International · Nov 2011
K110896 · RELIANCE SPINAL SCREW SYSTEM
Download PDF FDA Summary Reliance Medical Syst…