QKWClass II

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

21 CFR 888.3695 / Orthopedic

QKW is the FDA product code for Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis, a class II device type, regulated under 21 CFR 888.3695. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2022-12-16, and no recalls.

Classification record

Product code: QKW
Device name: Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
FDA 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.
Regulation: 21 CFR 888.3695
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code QKW

By decision year

1 clearance under product code QKW with a decision year between 2022 and 2022, 2022 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code QKW by decision year
Year	Clearances
2022	1

Applicants with the most clearances

Product code QKW

Applicants holding the most 510(k) clearances under product code QKW
Applicant	Clearances
Tornier S.A.S.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code QKW

DEN220012Class IITornier Pyrocarbon Humeral HeadTornier S.A.S. / cleared 2022-12-16

Recent recalls

Product code QKW

FDA records show no recalls under product code QKW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)