# K131231: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prothesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Oct 16, 2013 after 169 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: 11 generations back to K911686 (1991). 48 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) Summary page 7.
- K100142: Aequalis Reversed Shoulder Prosthesis, Tornier (2010) Summary page 7.
- K082120: Aequalis Reversed Fracture Shoulder Prothesis, Tornier (2008) Summary page 7.
- K062661: Aequalis Resurfacing Head, Tornier (2006) Summary page 8.

## Most influential descendants
- K220914: Tornier Perform Humeral System – Fracture (2022), 2 descendants of its own
- K240876: Identity Shoulder System (2024), 1 descendant of its own
- K141345: Aequalis FX2 (2014), 1 descendant of its own
- K253592: Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) (2026), 0 descendants of its own
- K152966: Aequalis Fx2 (2016), 0 descendants of its own

## Indications for use
Aequalis Range : Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies: arthrosis, rtheumatoid arthritis, post-traumatic arthrosis. Primary and secondary necrosis of the humeral head - Displaced 4-part upper humeral fracture - Humeral head fracture - Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable - Revision surgery when other treatments or devices have failed. Aequalis monobloc stem is for uncemented use only. The Aequalis press-Fit stem is for uncemented use only. The glenoid component is for cemented use only. Aequalis Fracture range: - Traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures. - Revisions when other devices or treatments have failed. The Aequalis fracture stem is for cemented use only. The glenoid component is for cemented use only. Aecqualis Resurfacing Head range: The resurfacing implant is indicated as a total or hemi shoulder joint replacement where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. The replacement of the joint with this device is indicated to relieve severe pain or significant disability caused by degenerative pathologies: osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, primary and secondary necrosis of the humeral head. The resurfacing implant is intended for uncemented use only. The glenoid component is for cemented use only. 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. Aequalis Reversed Fracture Shoulder Prosthesis The Aequalis Reversed Fracture Shoulder Prosthesis is indicated for patients with a functional deltoid muscle as a total shoulder replacement for the relief of pain or significant disability following arthropathy associated to a grossly deficient rotator cuff joint: - in case of traumatic or pathologic conditions of the shoulder resulting in fracture of the glenohumeral joint, including humeral head fracture and displaced 3-or 4-part proximal humeral fractures, or - in case of bone defect in proximal humerus. The Aequalis Reversed Fracture Shoulder Prosthesis is also indicated for prosthetic revisions with a grossly deficient rotator cuff joint when other treatments or devices have failed. 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 hemiprosthesis adaptor and the union screw can be adapted to the humeral components in order to transform the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis. When, in case of revision of a Aequalis Reversed Fracture Shoulder Prosthesis, the glenoid bone stock appears to be insufficient to implant a base plate and a sphere of Aequalis Reversed range again, the use of the hemi-prosthesis adaptor and the union screw allows for the transformation of the Aequalis Reversed Fracture Shoulder Prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components. The Aequalis Reversed Fracture Shoulder humeral stem is used in association with the glenoid components of the Aequalis Reversed Shoulder Prosthesis. The Aequalis Reversed Fracture Shoulder humeral stem is for cemented use only.

Source page: https://510kreport.com/device/K131231
Methodology: https://510kreport.com/methodology