# K112144: Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prosthesis - Pathway: 510(k) (Special) - Applicant: Tornier - Decided: Mar 13, 2012 after 231 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: 9 generations back to K911686 (1991). 38 ancestors in all. 23 later devices descend from it; 3 cite it directly. 0 of 62 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K952928: Aequalis Shoulder System for Total & Hemishoulder Applications, Tornier (1995) Summary page 6. - K041339: Aequalis Shoulder System, Tornier (2004) Summary page 6. - K043077: Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder System, Tornier (2004) Summary page 6. - K060209: Aequalis Shoulder Fracture System & Aequalis Shoulder System, Tornier (2006) Summary page 6. - K012212: Modification to Aequalis Shoulder System, Tornier (2001) Summary page 6. - K994392: Aequalis Shoulder Fracture System, Tornier (2000) Summary page 6. - K003728: Modification to Aequalis Shoulder Fracture System, Tornier (2000) Summary page 6. - K032679: Aequalis Shoulder Fracture System, Tornier (2003) Summary page 6. - K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 6. - K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 6. - K050316: Aequalis Reversed Shoulder Prosthesis, Tornier (2005) Summary page 6. - K061439: Aequalis Reversed Prosthesis, Tornier (2006) Summary page 6. - K081059: Aequalis Reversed Shoulder Prosthesis, Tornier (2008) Summary page 6. - K062250: Delta Xtend Reverse Shoulder System, DePuy Orthopaedics, Inc. (2007) Summary page 6. - K071379: Delta Xtend Reverse Shoulder Modular Stem, DePuy Orthopaedics, Inc. (2007) Summary page 6. - K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 6. - K071948: Aequalis Reversed Adapter, Tornier (2007) Summary page 6. ## Most influential descendants - K161863: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) (2016), 13 descendants of its own - K170452: Medacta Shoulder System (2017), 12 descendants of its own - K172210: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (2017), 10 descendants of its own - K181742: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (2018), 9 descendants of its own - K183039: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) (2019), 8 descendants of its own ## Indications for use Aequalis Shoulder Range (except Aequalis for Fracture): Prosthetic replacenient with this device may be indicated to relieve severe pain or significant disability caused by: - Degenerative pathologies: arthrosis, rheumatoid 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 sargery when other treatments or devices have failed. Aequalis monobloc stem is for use with cemented applications and is labeled as such. Aequalis Press-Fit stem is for uncemented applications and is labeled as such. Glenoid component is for use with cemented applications ad is labeled as such. Aequalis for Fracture: 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. Revision surgery when other treatments or devices have failed. Aequalis fracture stem is for cemented use. Aequalis Reversed Shoulder Prosthesis: 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 and non repairable rotator cuff-tear. This device is also indicated for the prosthetic revisions with massive and non repairablé 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 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 prosthesis into a non reversed hemi-prosthesis in order to avoid the revision of the humeral components. Aecqualis 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 dequalis 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/K112144 Methodology: https://510kreport.com/methodology