Cleared Traditional

K113324 - REXIOUS HOOK FIXATION SYSTEMS

K113324 is an FDA 510(k) clearance for REXIOUS HOOK FIXATION SYSTEMS, manufactured by Dio Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K113324 · Dio Medical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
139d
Days
Class 2
Risk

K113324 is an FDA 510(k) clearance for the REXIOUS HOOK FIXATION SYSTEMS. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Dio Medical Co., Ltd. (Brea, US). The FDA issued a Cleared decision on March 28, 2012 after a review of 139 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K113324

510(k) Number K113324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2011
Decision Date March 28, 2012
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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 410
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K113324.
M.U.S.T PEDICLE SCREW SYSTEM
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PIONEER POSTERIOR CERVICO THORACIC SYSTEM
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NEON SYSTEM
K113346 · Ulrich GmbH & Co. KG · Feb 2012
COFLEX-F
K112595 · Paradigm Spine, LLC · Feb 2012