Cleared Traditional

K122292 - RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM

K122292 is an FDA 510(k) clearance for RELIANCE POSTERIOR CERVICAL- THORACIC S..., manufactured by Reliance Medical Systems, LLC. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K122292 · Reliance Medical Systems, LLC · Orthopedic device
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Oct 2012
Decision
85d
Days
Class 2
Risk

K122292 is an FDA 510(k) clearance for the RELIANCE POSTERIOR CERVICAL- THORACIC SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on October 24, 2012 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Reliance Medical Systems, LLC devices

FDA 510(k) Submission Details - K122292

510(k) Number K122292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2012
Decision Date October 24, 2012
Days to Decision 85 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
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 381
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K122292.
VERTEX RECONSTRUCTION SYSTEM
K123568 · Medtronic Sofamor Danek USA, Inc. · Dec 2012
VERTIFLEX SPINOUS PROCESS FIXATION PLATE
K122509 · Vertiflex, Inc. · Dec 2012
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
K121725 · Pioneer Surgical Technology, Inc. · Nov 2012
SOLSTICE CROSS CONNECTOR
K120998 · Life Spine · Oct 2012
NEXTGEN ALTIUS OCT SYSTEM
K122378 · Biomet Spine (Aka Ebi, LLC) · Sep 2012
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
K121136 · Accel Spine · Aug 2012