Cleared Traditional

K103034 - GENESYS SPINE INTERBODY FUSION SYSTEM

K103034 is the FDA 510(k) clearance for GENESYS SPINE INTERBODY FUSION SYSTEM by Genesys Spine. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K103034 · Genesys Spine · Orthopedic device
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Dec 2010
Decision
58d
Days
Class 2
Risk

K103034 is an FDA 510(k) clearance for the GENESYS SPINE INTERBODY FUSION SYSTEM. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on December 10, 2010 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Genesys Spine devices

Submission Details

510(k) Number K103034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2010
Decision Date December 10, 2010
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 604
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K103034.
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