Cleared Traditional

K100765 - FIXPINE II SYSTEM

K100765 is an FDA 510(k) clearance for FIXPINE II SYSTEM, manufactured by Dio Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K100765 · Dio Medical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2010
Decision
124d
Days
Class 2
Risk

K100765 is an FDA 510(k) clearance for the FIXPINE II SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Dio Medical Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on July 19, 2010 after a review of 124 days - within the typical 510(k) review window.

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. 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.

View all Dio Medical Co., Ltd. devices

FDA 510(k) Submission Details - K100765

510(k) Number K100765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2010
Decision Date July 19, 2010
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
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 192
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K100765.
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LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
K100575 · Ldr Spine USA · Mar 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K093936 · Spineart · Mar 2010