# K082120: Aequalis Reversed Fracture Shoulder Prothesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Oct 24, 2008 after 88 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- 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: 9 generations back to K911686 (1991). 37 ancestors in all.
164 later devices descend from it; 9 cite it directly.
0 of 202 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 4.
- K041873: 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.
- K994392: Aequalis Shoulder Fracture System, Tornier (2000) Summary page 4.
- K003728: Modification to Aequalis Shoulder Fracture System, Tornier (2000) Summary page 4.
- K032679: Aequalis Shoulder Fracture System, Tornier (2003) Summary page 4.
- K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System, Tornier (2004) Summary page 4.
- K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) Summary page 4.
- K062250: Delta Xtend Reverse Shoulder System, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K071379: Delta Xtend Reverse Shoulder Modular Stem, DePuy Orthopaedics, Inc. (2007) Summary page 4.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 4.
- K071948: Aequalis Reversed Adapter, Tornier (2007). Our OCR of the scanned summary read K071943, FDA’s number for Serenity Pro PSF System (Inolase 2002, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aequalis Reversed Adapter”.

## Most influential descendants
- K100142: Aequalis Reversed Shoulder Prosthesis (2010), 147 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own
- K103208: Reverse Shoulder Prosthesis Monoblock Stem (2011), 59 descendants of its own

## Indications for use
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/K082120
Methodology: https://510kreport.com/methodology