510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220012Unknown

Tornier Pyrocarbon Humeral Head

Tornier S.A.S., Montbonnot-Saint-Martin, FR / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN220012 is the FDA 510(k) clearance record for Tornier Pyrocarbon Humeral Head, a class II device, cleared for Tornier S.A.S. on under FDA product code QKW (Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis). FDA's definition for product code QKW 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...". FDA records list 20 510(k) clearances for Tornier S.A.S., from to . As of , FDA records show no recalls naming DEN220012.

Clearance record

Decision date
Received
(311 days to decision)
Product code
QKW Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
Regulation
21 CFR 888.3695
Device class
Class II
Review panel
Orthopedic
Applicant
Tornier S.A.S. 161 Rue Lavoisier, Montbonnot-Saint-Martin, FR
Third party review
No

Clearances, product code QKW

Trailing 12 months

FDA records hold no clearances under product code QKW in the trailing twelve months.

FDA records show no clearances under product code QKW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QKW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260