QKW — Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis Class II

FDA Device Classification

Classification Details

Product Code
QKW
Device Class
Class II
Regulation Number
888.3695
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
DEN220012tornierTornier Pyrocarbon Humeral HeadDecember 16, 2022