Not Cleared Post-NSE

DEN220012 - Tornier Pyrocarbon Humeral Head (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN220012 · Tornier S.A.S. · Orthopedic device
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Dec 2022
Decision
311d
Days
Class 2
Risk

DEN220012 is an FDA 510(k) submission (not cleared) for the Tornier Pyrocarbon Humeral Head. Classified as Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented Or Uncemented Prosthesis (product code QKW), Class II - Special Controls.

Submitted by Tornier S.A.S. (Montbonnot-Saint-Martin, FR). The FDA issued a Not Cleared (DENG) decision on December 16, 2022 after a review of 311 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3695 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 311 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Tornier S.A.S. devices

Submission Details

510(k) Number DEN220012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 08, 2022
Decision Date December 16, 2022
Days to Decision 311 days
Submission Type Post-NSE
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 122d · This submission: 311d
Pathway characteristics

Device Classification

Product Code QKW Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented Or Uncemented Prosthesis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3695
Definition A Shoulder Joint Humeral (hemi-shoulder) Ceramic Head / Metallic Stem Cemented Or Uncemented Prosthesis Is A Device Using A Replacement Humeral Head Made Of Ceramic Materials, Such As Pyrolytic Carbon,and A Stem Made Of Alloys, Such As Cobalt-chromium-molybdenum. It Is Intended To Be Implanted To Replace The Articular Surface Of The Proximal End Of The Humerus And To Be Fixed With Or Without Bone Cement (§ 888.3027). This Device Is Not Intended For Use In Total Shoulder Arthroplasty.
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.