Cleared Traditional

K071810 - INION SPINAL GRAFT CONTAINMENT SYSTEM (FDA 510(k) Clearance)

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

K071810 · Inion , Ltd. · Orthopedic device
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Jul 2008
Decision
375d
Days
Class 2
Risk

K071810 is an FDA 510(k) clearance for the INION SPINAL GRAFT CONTAINMENT SYSTEM. Classified as Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate (product code OJB), Class II - Special Controls.

Submitted by Inion , Ltd. (Tampere, FI). The FDA issued a Cleared decision on July 11, 2008 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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Submission Details

510(k) Number K071810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 02, 2007
Decision Date July 11, 2008
Days to Decision 375 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
253d slower than avg
Panel avg: 122d · This submission: 375d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OJB Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
Definition Maintain Position Of Bone Graft In Spinal Fusion Procedures. Intended For Use In Spinal Fusion Procedures As A Means To Maintain The Relative Position Of Weak Bony Tissue Such As Allografts Or Autografts, In Conjunction With Traditional Rigid Fixation.
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.