# K030941: Aequalis Reversed Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: May 14, 2004 after 416 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: 4 generations back to K911686 (1991). 11 ancestors in all.
280 later devices descend from it; 17 cite it directly.
1 of 292 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991585: Bipolar Shoulder Prosthesis, Biomet, Inc. (1999) Summary page 1.
- K021478: Delta Shoulder, Depuy, Inc. (2003). Cleared while this submission was under review Summary page 1.
- K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 1.

## Most influential descendants
- K041873: Aequalis Reversed Shoulder Prosthesis (2004), 277 descendants of its own
- 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

## 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 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 Prosthesis humeral component is intended for cemented use only and the glenoid component is intended for non cemented use with 4 screws for fixation.

Source page: https://510kreport.com/device/K030941
Methodology: https://510kreport.com/methodology