Cleared Traditional

K051704 - MYKRES SPINAL SYSTEM

K051704 is an FDA 510(k) clearance for MYKRES SPINAL SYSTEM, manufactured by Showa Ika Kohgyo Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K051704 · Showa Ika Kohgyo Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
374d
Days
Class 2
Risk

K051704 is an FDA 510(k) clearance for the MYKRES SPINAL SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Showa Ika Kohgyo Co., Ltd. (San Diego,, US). The FDA issued a Cleared decision on July 3, 2006 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Showa Ika Kohgyo Co., Ltd. devices

FDA 510(k) Submission Details - K051704

510(k) Number K051704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2005
Decision Date July 03, 2006
Days to Decision 374 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
252d slower than avg
Panel avg: 122d · This submission: 374d
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 206
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K051704.
ARX SPINAL SYSTEM
K061600 · Life Spine · Aug 2006
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM
K061978 · Ebi, L.P. · Aug 2006
EASYSPINE SYSTEM
K061017 · Ldr Spine USA · Aug 2006
MODIFICATION TO S4 SPINAL SYSTEM
K060152 · Aesculap, Inc. · Feb 2006
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K053483 · Medtronic Sofamor Danek · Jan 2006
CAPLESS PEDICLE SCREW SYSTEM
K052847 · X-Spine Systems, Inc. · Dec 2005