Cleared Traditional

K121304 - OSTEOMED CRANIAL DISTRACTION SYSTEM (FDA 510(k) Clearance)

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

K121304 · Osteomed · Neurology device
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Aug 2012
Decision
113d
Days
Class 2
Risk

K121304 is an FDA 510(k) clearance for the OSTEOMED CRANIAL DISTRACTION SYSTEM. Classified as Cranial Distraction System (product code PBJ), Class II - Special Controls.

Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on August 22, 2012 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5330 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K121304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2012
Decision Date August 22, 2012
Days to Decision 113 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 148d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBJ Cranial Distraction System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5330
Definition A Cranial Distraction System Is A Metal Device Intended To Establish Osteodistraction And Bone Growth In The Skull. The Bone Segments Are Attached To The Plate With Screws To Prevent Movement Of The Segments.
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 Neurology devices follow this clearance model.