# K132285: Aequalis Reversed Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Dec 5, 2013 after 135 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: 14 generations back to K911686 (1991). 101 ancestors in all.
26 later devices descend from it; 4 cite it directly.
1 of 128 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 4.
- K050316: Aequalis Reversed Shoulder Prosthesis, Tornier (2005) Summary page 4.
- K061439: Aequalis Reversed Prosthesis, Tornier (2006) Summary page 4.
- K081059: Aequalis Reversed Shoulder Prosthesis, Tornier (2008) Summary page 4.
- K100142: Aequalis Reversed Shoulder Prosthesis, Tornier (2010) Summary page 4.
- K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013) Summary page 4.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K092873: Reverse Shoulder Prosthesis, Djo Surgical (2009) Summary page 4.

## Most influential descendants
- K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (2015), 20 descendants of its own
- K190521: Aequalis Ascend Flex Shoulder System (2019), 12 descendants of its own
- K201315: PERFORM Humeral System – Stem (2020), 11 descendants of its own
- K220847: AETOS Shoulder System (2023), 5 descendants of its own
- K240716: AETOS Shoulder System Stemless Humeral Prosthesis (2024), 3 descendants of its own

## Indications for use
Cemented Aequalis Reversed -prosthesis: It 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 with the 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 into 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. Uncemented Aequalis Reversed prosthesis: It 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. The humeral components are for non-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 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 into a non reversed hemi-prosthesis. When, in case of revision of an 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/K132285
Methodology: https://510kreport.com/methodology