510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140478Substantially Equivalent

Aequalis Reversed Shoulder Prosthesis

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

K140478 is the FDA 510(k) clearance record for AEQUALIS REVERSED SHOULDER PROSTHESIS, 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 no recalls naming K140478.

Clearance record

Decision date
Received
(161 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