510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183194Substantially Equivalent

Arthrex Eclipse Shoulder Prosthesis System

Arthrex GmbH, Naples FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183194 is the FDA 510(k) clearance record for Arthrex Eclipse Shoulder Prosthesis System, a class II device, cleared for Arthrex, Inc. on under FDA product code QHQ (Total Shoulder Arthroplasty System). FDA's definition for product code QHQ reads: "To treat pain and lack of function in the shoulder". FDA records list 352 510(k) clearances for Arthrex, Inc., from to . As of , FDA records show no recalls naming K183194.

Clearance record

Decision date
Received
(249 days to decision)
Product code
QHQ Total Shoulder Arthroplasty System
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Arthrex, Inc. 1370 Creekside Blvd., Naples FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QHQ

Trailing 12 months

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

FDA records show no clearances under product code QHQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QHQ, 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