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
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Shoulder Joint Humeral (hemi-shoulder) Ceramic Head/metallic Stem Cemented Or Uncemented Prosthesis Devices (Product Code QKW)

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

About Product Code QKW - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QKW since 2022, with 0 receiving FDA clearance (average review time: 311 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QKW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →