Cleared Traditional

K051821 - INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM (FDA 510(k) Clearance)

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

K051821 · Inion , Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
143d
Days
Class 2
Risk

K051821 is an FDA 510(k) clearance for the INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION 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 November 25, 2005 after a review of 143 days - within the typical 510(k) review window.

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 Inion , Ltd. devices

Submission Details

510(k) Number K051821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2005
Decision Date November 25, 2005
Days to Decision 143 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
21d slower than avg
Panel avg: 122d · This submission: 143d
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.