510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192365Substantially Equivalent

Shoulder Innovations Total Shoulder System

SHOULDER INNOVATIONS, Inc, Holland MI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192365 is the FDA 510(k) clearance record for Shoulder Innovations Total Shoulder System, a class II device, cleared for Shoulder Innovations, Inc. on under FDA product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented). FDA records list 11 510(k) clearances for Shoulder Innovations, Inc., from to . As of , FDA records show no recalls naming K192365.

Clearance record

Decision date
Received
(91 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
Shoulder Innovations, Inc. 13827 Port Sheldon St., Holland MI
510(k) summary
Summary PDF
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