Cleared Special

K024313 - MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM

K024313 is an FDA 510(k) clearance for MODIFICATION TO UNIVERSAL MULTIAXIS (UN..., manufactured by Pisharodi Surgicals, Inc.. The device is a Class 2 Orthopedic device with product code MNI cleared through the Special 510(k) pathway after a 248-day FDA review.

K024313 · Pisharodi Surgicals, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
248d
Days
Class 2
Risk

K024313 is an FDA 510(k) clearance for the MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM. Classified as Orthosis, Spinal Pedicle Fixation (product code MNI), Class II - Special Controls.

Submitted by Pisharodi Surgicals, Inc. (Round Rock, US). The FDA issued a Cleared decision on August 29, 2003 after a review of 248 days - an extended review 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K024313

510(k) Number K024313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2002
Decision Date August 29, 2003
Days to Decision 248 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
126d slower than avg
Panel avg: 122d · This submission: 248d
Pathway characteristics
Modification to existing cleared device.

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 302
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K024313.
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
K031985 · Spinal Concepts, Inc. · Sep 2003
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
K032037 · Medtronic Sofamor Danek · Sep 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031833 · Medtronic Sofamor Danek · Sep 2003
EBI OMEGA21 SPINAL FIXATION SYSTEM
K031354 · Ebi, L.P. · Aug 2003
UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
K031381 · Seaspine · Jul 2003
CD HORIZON SPINAL SYSTEM
K031655 · Medtronic Sofamor Danek USA, Inc. · Jun 2003
K024313 · MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
Download PDF FDA Summary Pisharodi Surgicals, …