510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191698Substantially Equivalent

TiN Coated Humeral Head

Fx Shoulder USA, Inc., Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191698 is the FDA 510(k) clearance record for TiN Coated Humeral Head, a class II device, cleared for Fx Shoulder USA, Inc. on under FDA product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented). FDA records list 11 510(k) clearances for Fx Shoulder USA, Inc., from to . As of , FDA records show no recalls naming K191698.

Clearance record

Decision date
Received
(387 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
Fx Shoulder USA, Inc. 13465 Midway Rd., Dallas TX
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