Product Code: QKW FDA class 2 21 CFR 888.3695

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

Orthopedic

The Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis is a Class 2 orthopedic implant featuring a humeral head made of ceramic materials such as pyrolytic carbon and a stem made of alloys such as cobalt-chromium-molybdenum, intended to replace the articular surface of the proximal end of the humerus with or without bone cement, and is specifically not intended for total shoulder arthroplasty. It requires 510(k) clearance and is regulated under 21 CFR 888.3695 within the Orthopedic medical specialty. The product code is QKW, and the device carries an implant flag. It is not flagged as life-sustaining.

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Basic Information

Product Code: QKW
Device Class: FDA class 2
Regulation Number: 888.3695
Medical Specialty: Orthopedic
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

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.