FDA product code QKW: Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

QKW is the FDA product code for shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis. It is a Class II device, regulated under 21 CFR 888.3695 and reviewed by the Orthopedic panel. Devices under QKW reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.

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.

Classification

Recalls for QKW devices

openFDA lists no recalls for product code QKW.

Frequently asked questions

What is FDA product code QKW?

QKW is the FDA product code for shoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis. It is a Class II device, regulated under 21 CFR 888.3695 and reviewed by the Orthopedic panel.

What device class is QKW?

Class II, regulation 21 CFR 888.3695. Typical premarket route: 510(k).

Next steps

• Run an FDA pathway report with predicate devices for product code QKW
• Run a recall and safety report across every QKW manufacturer
• Watch product code QKW for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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