Cleared Special

K990657 - TRIFIX PEDICLE SPINAL SCREW ASSEMBLY

K990657 is an FDA 510(k) clearance for TRIFIX PEDICLE SPINAL SCREW ASSEMBLY, 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 25-day FDA review.

K990657 · Corin USA · Orthopedic device
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Mar 1999
Decision
25d
Days
Class 2
Risk

K990657 is an FDA 510(k) clearance for the TRIFIX PEDICLE SPINAL SCREW ASSEMBLY. 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 March 26, 1999 after a review of 25 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 - K990657

510(k) Number K990657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1999
Decision Date March 26, 1999
Days to Decision 25 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 122d · This submission: 25d
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 K990657.
SYNTHES PEDIATRIC ROD SYSTEM
K991552 · Synthes (Usa) · Jun 1999
MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR
K991528 · Danek Medical, Inc. · May 1999
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
K991364 · Sofamor Danek USA,Inc. · May 1999
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
K984302 · Osteonics Corp. · Dec 1998
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS
K983152 · Osteonics Corp. · Sep 1998
SYNTHES SPINE PEDIATRIC ROD SYSTEM
K980761 · Synthes Spine · Aug 1998