510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192206Substantially Equivalent

32mm Glenosphere and Humeral Cup

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

K192206 is the FDA 510(k) clearance record for 32mm Glenosphere and Humeral Cup, a class II device, cleared for Fx Shoulder USA, Inc. on under FDA product code PHX (Shoulder Prosthesis, Reverse Configuration). FDA's definition for product code PHX reads: "Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a...". FDA records list 11 510(k) clearances for Fx Shoulder USA, Inc., from to . As of , FDA records show one recall naming K192206.

Clearance record

Decision date
Received
(55 days to decision)
Product code
PHX Shoulder Prosthesis, Reverse Configuration
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 PHX

Trailing 12 months
16 clearances under product code PHX in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code PHX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20265
February 20261
March 20261
April 20264
May 20261
June 20263
July 20261
August 20260
September 20260
October 20260