510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K010869Substantially Equivalent

Epoca Custom Offset Shoulder System

Argomedical AG, Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010869 is the FDA 510(k) clearance record for EPOCA CUSTOM OFFSET SHOULDER SYSTEM, a class II device, cleared for Argomedical AG on under FDA product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented). FDA records list one 510(k) clearance for Argomedical AG. As of , FDA records show no recalls naming K010869.

Clearance record

Decision date
Received
(202 days to decision)
Product code
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Regulation
21 CFR 888.3650
Device class
Class II
Review panel
Orthopedic
Applicant
Argomedical AG 800 Vinal St., Suite B-210, Pittsburgh PA
510(k) summary
Statement
Third party review
No

Clearances, product code KWT

Trailing 12 months
2 clearances under product code KWT in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KWT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260