510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K141345Substantially Equivalent

Aequalis Fx2

Tornier S.A.S., Montbonnot-Saint-Martin, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K141345 is the FDA 510(k) clearance record for AEQUALIS FX2, a class II device, cleared for Tornier S.A.S. 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 20 510(k) clearances for Tornier S.A.S., from to . As of , FDA records show one recall naming K141345.

Clearance record

Decision date
Received
(180 days to decision)
Product code
PHX Shoulder Prosthesis, Reverse Configuration
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Tornier S.A.S. 161 Rue Lavoisier, Montbonnot-Saint-Martin, FR
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