Cleared Special

K010776 - TRINITY POLYAXIAL SCREW

K010776 is an FDA 510(k) clearance for TRINITY POLYAXIAL SCREW, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 23-day FDA review.

K010776 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
23d
Days
Class 2
Risk

K010776 is an FDA 510(k) clearance for the TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATAL.... Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on April 6, 2001 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Corin USA devices

FDA 510(k) Submission Details - K010776

510(k) Number K010776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2001
Decision Date April 06, 2001
Days to Decision 23 days
Submission Type Special
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
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 172
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K010776.
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TSRH SPINAL SYSTEM
K010720 · Medtronic Sofamor Danek, Inc. · Apr 2001
TRIFIX SPINAL FIXATION SYSTEM
K010535 · Endius, Inc. · Mar 2001
CD HORIZON SPINAL SYSTEM
K010249 · Medtronic Sofamor Danek, Inc. · Feb 2001
MODIFICATION TO EBI SPINELINK SYSTEM
K003764 · Ebi, L.P. · Jan 2001