510(k) DEN220012
DEN220012 is an FDA 510(k) premarket notification submitted by Tornier S.A.S. for the device "Tornier Pyrocarbon Humeral Head". The FDA issued a decision of De Novo Granted on December 16, 2022. The device falls under product code QKW (Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis), a Class II device regulated under 21 CFR 888.3695. Tornier S.A.S. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 16, 2022
- Date Received
- February 8, 2022
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
- Device Class
- Class II
- Regulation Number
- 888.3695
- Review Panel
- OR
- Submission Type
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.