Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis
K112144 is the FDA 510(k) clearance record for AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS, 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 K112144.
Clearance record
Clearances, product code PHX
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 5 |
| February 2026 | 1 |
| March 2026 | 1 |
| April 2026 | 4 |
| May 2026 | 1 |
| June 2026 | 3 |
| July 2026 | 1 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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