Cleared Special

MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM (K024313) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K024313 · Pisharodi Surgicals, Inc. · Orthopedic device
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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.

View all Pisharodi Surgicals, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 122d · This submission: 248d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 30
Devices cleared under the same product code (MNI) and FDA review panel - the closest regulatory comparables to K024313.
DYNALOK CLASSIC SPINAL SYSTEM
K033271 · Medtronic Sofamor Danek · Nov 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
CD HORIZON SPINAL SYSTEM
K031655 · Medtronic Sofamor Danek USA, Inc. · Jun 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888 · Medtronic Sofamor Danek · Jun 2003
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949 · Synthes (Usa) · Mar 2003