# K041873: Aequalis Reversed Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Aug 25, 2004 after 44 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: 5 generations back to K911686 (1991). 12 ancestors in all.
277 later devices descend from it; 13 cite it directly.
1 of 290 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)
- 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
- K050316: Aequalis Reversed Shoulder Prosthesis (2005), 248 descendants of its own
- K053274: Anatomical Shoulder Inverse/Reverse (2006), 239 descendants of its own
- K052906: Zimmer Trabecular Metal Reverse Shoulder System (2005), 216 descendants of its own
- K060704: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM (2006), 207 descendants of its own
- K061439: Aequalis Reversed Prosthesis (2006), 199 descendants of its own

## Indications for use
The Aequalis Reversed Shoulder Prosthesis is indicated for patients, with a runctional deltoid muscle, as a total shoulder replacement for the relief of pain and significant disability following arthropathy associated to massive non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairable rotator cuff-tear. The Aequalis Reversed Shoulder Prosfhesis humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation. When during the primary surgery the glenoid 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 hurneral components in order to transform the Reversed prosthesis in to a non reversed hemi-prosthesis_ When, in case of revision of a Reversed prosthesis, the glenoid bone stock appears to be insufficient to again implant a base plate and a sphere of Reversed range, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Reversed prosthesis in to an anatomical non reversed hemi-prosthesis in order to avoid the revision of the humeral components.

Source page: https://510kreport.com/device/K041873
Methodology: https://510kreport.com/methodology