Cleared Traditional

K100373 - TYCHE PEDICLE SCREW SYSTEM

K100373 is an FDA 510(k) clearance for TYCHE PEDICLE SCREW SYSTEM, manufactured by Kyung Won Medical Co., Ltd.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K100373 · Kyung Won Medical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
138d
Days
Class 2
Risk

K100373 is an FDA 510(k) clearance for the TYCHE PEDICLE SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Kyung Won Medical Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on June 30, 2010 after a review of 138 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 Kyung Won Medical Co., Ltd. devices

FDA 510(k) Submission Details - K100373

510(k) Number K100373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date June 30, 2010
Days to Decision 138 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
16d slower than avg
Panel avg: 122d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal 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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 201
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K100373.
QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM
K093771 · Pioneer Surgical Technology · Aug 2010
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K101678 · Spineart · Jul 2010
VENUS BASIC SPINAL FIXATION SYSTEM
K100706 · L & K Biomed Co., Ltd. · Jul 2010
MIS SYSTEM
K100605 · Spine Wave, Inc. · Jun 2010
MODIFICATION TO: OASYS SYSTEM
K093670 · Stryker Spine · Mar 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122 · Spine Wave, Inc. · Feb 2010