510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080990Substantially Equivalent

Depuy Global C.ap. Cta Resurfacing Shoulder

Depuy Orthopaedics Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080990 is the FDA 510(k) clearance record for DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER, a class II device, cleared for DePuy Orthopaedics, Inc. on under FDA product code HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented). FDA records list 209 510(k) clearances for DePuy Orthopaedics, Inc., from to . As of , FDA records show no recalls naming K080990.

Clearance record

Decision date
Received
(123 days to decision)
Product code
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Regulation
21 CFR 888.3690
Device class
Class II
Review panel
Orthopedic
Applicant
DePuy Orthopaedics, Inc. 700 Orthopaedic Dr., Warsaw IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HSD

Trailing 12 months

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

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