# K050316: Aequalis Reversed Shoulder Prosthesis

- Pathway: 510(k) (Special)
- Applicant: Tornier
- Decided: Mar 16, 2005 after 35 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911686 (1991). 13 ancestors in all.
248 later devices descend from it; 9 cite it directly.
1 of 262 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 1.
- K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 1.
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 1.
- K991585: Bipolar Shoulder Prosthesis, Biomet, Inc. (1999) Summary page 1.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 1.

## Most influential descendants
- K061439: Aequalis Reversed Prosthesis (2006), 199 descendants of its own
- K063569: Equinoxe Reverse Shoulder System (2007), 190 descendants of its own
- K081059: Aequalis Reversed Shoulder Prosthesis (2008), 179 descendants of its own
- K071948: Aequalis Reversed Adapter (2007), 178 descendants of its own
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw (2008), 177 descendants of its own

## Indications for use
The Aequalis Reversed Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. Only the humeral components are for cemented use. The glenoid implant is anchored to the bone with 4 screws and is for non-cemented fixation- When during the primary surgery the glenoid bone stock appears to be insufficient to bear the reversed glenoid components or when glenoid bone fracture occurs during the surgical procedures, the hemi-prosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis. When, in case of revision of a Aequalis Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Aequalis Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed prosthesis in to a non reversed hemi-prosthesis in order to avoid the revision of the humeral components-

Source page: https://510kreport.com/device/K050316
Methodology: https://510kreport.com/methodology