DEN220012 is an FDA 510(k) submission for the Tornier Pyrocarbon Humeral Head. This device is classified as a Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented Or Uncemented Prosthesis (Class II - Special Controls, product code QKW).
Submitted by Tornier S.A.S. (Montbonnot-Saint-Martin, FR). The FDA issued a Not Cleared (DENG) decision on December 16, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3695. 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..
| 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 | — |
| Product Code | QKW — Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented Or Uncemented Prosthesis |
| Device Class | Class II - 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. |