Cleared Special

K020204 - TELESCOPIC PLATE SPACER THORACOLUMBAR (...

K020204 is the FDA 510(k) clearance for TELESCOPIC PLATE SPACER THORACOLUMBAR (... by Interpore Cross Intl.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K020204 · Interpore Cross Intl. · Orthopedic device
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Feb 2002
Decision
30d
Days
Class 2
Risk

K020204 is an FDA 510(k) clearance for the TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 81.... Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Interpore Cross Intl. (Irvine, US). The FDA issued a Cleared decision on February 21, 2002 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Interpore Cross Intl. devices

Submission Details

510(k) Number K020204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date February 21, 2002
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - MQP Spinal Vertebral Body Replacement Device

All 161
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K020204.
EBI AIS SPINE SYSTEM
K020887 · Ebi, L.P. · May 2002
SYNTHES VERTEBRAL SPACER TI
K020152 · Synthes (Usa) · Apr 2002
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522 · Depuyacromed · Mar 2002
MODIFICATION TO GEO STRUCTURE
K020048 · Interpore Cross Intl. · Feb 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K010378 · Implex Corp. · Jan 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131
K014145 · Interpore Cross Intl. · Jan 2002