Cleared Traditional

K081978 - RELIANCE SPINAL SCREW SYSTEM

K081978 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 Traditional 510(k) pathway after a 258-day FDA review.

K081978 · Reliance Medical Systems, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K081978

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
Combination Product No
PCCP Authorized No
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.

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 248
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K081978.
INERTIA PEDICLE SCREW SYSTEM
K090984 · Nexxt Spine, LLC · Jun 2009
MODIFICATION TO: PSS SYSTEM
K090033 · Spinal USA · May 2009
THEKEN ATOLL OCT SPINAL SYSTEM
K083863 · Theken Spine, LLC · Mar 2009
THEKEN ATOLL CERVICO-THORACIC SYSTEM
K083073 · Theken Spine, LLC · Mar 2009
PILOT SPINAL SYSTEM
K083865 · Life Spine · Jan 2009
CAPSURE PS SYSTEM
K083743 · Spine Wave, Inc. · Jan 2009