510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K844415Substantially Equivalent

Porocoat New Jersey Shoulder Replacement Sys

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

K844415 is the FDA 510(k) clearance record for POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS, a class II device, cleared for Depuy, Inc. on under FDA product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented). FDA records list 220 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K844415.

Clearance record

Decision date
Received
(70 days to decision)
Product code
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Regulation
21 CFR 888.3670
Device class
Class II
Review panel
Orthopedic
Applicant
Depuy, Inc. P.O. Box 988, Warsaw IN
Third party review
No

Clearances, product code MBF

Trailing 12 months
1 clearance under product code MBF in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MBF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260