510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201391Substantially Equivalent

Easytech® Anatomical Shoulder System

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

K201391 is the FDA 510(k) clearance record for Easytech® Anatomical Shoulder System, a class II device, cleared for Fx Shoulder USA, Inc. on under FDA product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained). FDA's definition for product code PKC reads: "Replacement of the humeral head for total anatomic shoulder arthroplasty". FDA records list 11 510(k) clearances for Fx Shoulder USA, Inc., from to . As of , FDA records show no recalls naming K201391.

Clearance record

Decision date
Received
(265 days to decision)
Product code
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Regulation
21 CFR 888.3660
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 PKC

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