DeviceClearance

Product code QKW— Orthopedic

Tornier Pyrocarbon Humeral Head

Classification name
Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
Device class
Class 2
Regulation
21 CFR 888.3695
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QKW under 21 CFR 888.3695, via openFDA

Market context for product code QKW

FDA has cleared 1 device under product code QKW, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QKW

Recent clearances under product code QKW

Data sourced from openFDA. This site is unofficial and independent of the FDA.