QKW · Class II · 21 CFR 888.3695

FDA Product Code QKW: Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented Or Uncemented Prosthesis

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.

Leading manufacturers include Tornier S.A.S..

1
Total
0
Cleared
311d
Avg days
2022
Since

List of Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented Or Uncemented Prosthesis devices cleared through 510(k)

1 devices
1–1 of 1
Not Cleared Dec 16, 2022
Tornier Pyrocarbon Humeral Head
DEN220012
Tornier S.A.S.
Orthopedic · 311d

How to use this database

This page lists all FDA 510(k) submissions for Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented Or Uncemented Prosthesis devices (product code QKW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →