Cleared Traditional

GEO STRUCTURE (K010530) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010530 · Interpore Cross Intl. · Orthopedic device
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Aug 2001
Decision
161d
Days
Class 2
Risk

K010530 is an FDA 510(k) clearance for the GEO STRUCTURE. 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 August 3, 2001 after a review of 161 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Interpore Cross Intl. devices

Submission Details

510(k) Number K010530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2001
Decision Date August 03, 2001
Days to Decision 161 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 122d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 68
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K010530.
VERTE-STACK SPINAL SYSTEM
K021791 · Medtronic Sofamor Danek · Aug 2002
VERTEBRAL SPACER
K011037 · Synthes (Usa) · Jul 2002
SYNTHES VERTEBRAL SPACER TI
K020152 · Synthes (Usa) · Apr 2002
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · United States Surgical, A Division of Tyco Healthc · Jul 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275 · Synthes (Usa) · Apr 2001