Cleared Traditional

SUSTAIN SPACER (K031302) - FDA 510(k) Clearance

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

K031302 · Globus Medical, Inc. · Orthopedic device
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Jun 2003
Decision
64d
Days
Class 2
Risk

K031302 is an FDA 510(k) clearance for the SUSTAIN SPACER. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Phoenixville, US). The FDA issued a Cleared decision on June 27, 2003 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K031302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2003
Decision Date June 27, 2003
Days to Decision 64 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 67
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K031302.
VERTE-STACK SPINAL SYSTEM
K040167 · Medtronic Sofamor Danek · Feb 2004
STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
K033837 · Howmedica Osteonics Corp. · Jan 2004
VERTE-STACK SPINAL SYSTEM
K031780 · Medtronic Sofamor Danek · Jul 2003
MODIFIED VERTE-STACK SPINAL SYSTEM
K030735 · Medtronic Sofamor Danek · Apr 2003
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
K030736 · Medtronic Sofamor Danek · Apr 2003
VERTE-STACK SPINAL SYSTEM
K030601 · Medtronic Sofamor Danek · Mar 2003