Cleared Traditional

K081978 - RELIANCE SPINAL SCREW SYSTEM

K081978 is the FDA 510(k) clearance for RELIANCE SPINAL SCREW SYSTEM by Reliance Medical Systems, LLC. It is a Class 2 Orthopedic device (product code MNI) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K081978 · Reliance Medical Systems, LLC · Orthopedic device
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Mar 2009
Decision
258d
Days
Class 2
Risk

K081978 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 (Sandy, US). The FDA issued a Cleared decision on March 26, 2009 after a review of 258 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 Reliance Medical Systems, LLC devices

Submission Details

510(k) Number K081978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2008
Decision Date March 26, 2009
Days to Decision 258 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
136d slower than avg
Panel avg: 122d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 160
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K081978.
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093170 · Spineart · Nov 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189 · Alphatec Spine, Inc. · Jul 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K090779 · Alphatec Spine, Inc. · Jul 2009
PILOT SPINAL SYSTEM
K083865 · Life Spine · Jan 2009
CAPSURE PS SYSTEM
K083743 · Spine Wave, Inc. · Jan 2009
CAPSURE(R) PS SYSTEM
K083353 · Spine Wave, Inc. · Dec 2008