Cleared Traditional

K071074 - MYKRES SPINAL SYSTEM

K071074 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 443-day FDA review.

K071074 · Showa Ika Kohgyo Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
443d
Days
Class 2
Risk

K071074 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 2, 2008 after a review of 443 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Showa Ika Kohgyo Co., Ltd. devices

FDA 510(k) Submission Details - K071074

510(k) Number K071074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2007
Decision Date July 02, 2008
Days to Decision 443 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
321d slower than avg
Panel avg: 122d · This submission: 443d
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 K071074.
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COSMIC SYSTEM
K080841 · Ulrich GmbH & Co. KG · Jul 2008
ZODIC POLYAXIAL SPINAL FIXATION SYSTEM
K081158 · Alphatec Spine, Inc. · Jul 2008
CONQUEST SPINAL SYSTEM
K080767 · Life Spine · May 2008
CAPSURE PS (R) SPINE SYSTEM
K081228 · Spine Wave, Inc. · May 2008
MODIFICATION TO:PILOT SPINAL SYSTEM
K080502 · Life Spine · Apr 2008