510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K071948Substantially Equivalent

Aequalis Reversed Adapter

TORNIER Inc., Saint-Ismier Cedex, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071948 is the FDA 510(k) clearance record for AEQUALIS REVERSED ADAPTER, a class II device, cleared for Tornier 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 140 510(k) clearances for Tornier, from to . As of , FDA records show no recalls naming K071948.

Clearance record

Decision date
Received
(97 days to decision)
Product code
PHX Shoulder Prosthesis, Reverse Configuration
Regulation
21 CFR 888.3660
Device class
Class II
Review panel
Orthopedic
Applicant
Tornier 161 Rue Lavoisier, Saint-Ismier Cedex, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PHX

Trailing 12 months
18 clearances under product code PHX in the twelve months to November 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code PHX, trailing twelve months
MonthClearances
December 20250
January 20265
February 20261
March 20261
April 20264
May 20261
June 20263
July 20261
August 20260
September 20260
October 20262
November 20260