Cleared Traditional

K073303 - NORIAN DRILLABLE (FDA 510(k) Clearance)

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

K073303 · Synthes (Usa) · Orthopedic device
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Jul 2008
Decision
222d
Days
Class 2
Risk

K073303 is an FDA 510(k) clearance for the NORIAN DRILLABLE. Classified as Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation (product code OIS), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on July 2, 2008 after a review of 222 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K073303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 23, 2007
Decision Date July 02, 2008
Days to Decision 222 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
100d slower than avg
Panel avg: 122d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OIS Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
Definition To Fill Traumatic Or Surgically-created Defects Not Intrinsic To The Stability Of The Bony Structure. It Is Delivered To The Defect And Resorbs Over Time To Be Replaced By Bone. Not For Screw Augmentation.
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.