Cleared Special

K101112 - RELIANCE SPINAL SCREW SYSTEM

K101112 is an FDA 510(k) clearance for RELIANCE SPINAL SCREW SYSTEM, manufactured by Reliance Medical Systems. The device is a Class 2 Orthopedic device with product code KWP cleared through the Special 510(k) pathway after a 197-day FDA review.

K101112 · Reliance Medical Systems · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
197d
Days
Class 2
Risk

K101112 is an FDA 510(k) clearance for the RELIANCE SPINAL SCREW SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Reliance Medical Systems (Bountiful, US). The FDA issued a Cleared decision on November 4, 2010 after a review of 197 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 - K101112

510(k) Number K101112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2010
Decision Date November 04, 2010
Days to Decision 197 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 122d · This submission: 197d
Pathway characteristics
Modification to existing cleared device.

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 425
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K101112.
AXLE INTERSPINOUS FUSION SYSTEM
K101471 · X-Spine Systems, Inc. · Nov 2010
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM
K100888 · Lanx, Inc. · Nov 2010
MODIFICATION TO: OASYS SYSTEM
K101183 · Stryker Spine · Nov 2010
PIONEER SPINOUS PROCESS FUSION PLATE
K101525 · Pioneer Surgical Technology · Oct 2010
PARADIGM INTERSPINOUS FUSION PLATE
K093438 · Paradigm Spine, LLC · Oct 2010
CASPIAN SPINAL SYSTEM
K101084 · K2m, Inc. · Oct 2010
K101112 · RELIANCE SPINAL SCREW SYSTEM
Download PDF FDA Summary Reliance Medical Syst…