# K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis - Pathway: 510(k) (Special) - Applicant: Tornier S.A.S. - Decided: Sep 24, 2015 after 132 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: 15 generations back to K911686 (1991). 137 ancestors in all. 20 later devices descend from it; 4 cite it directly. 1 of 158 devices in its family (counting itself) has a Class I recall. ## Predicates on the family tree (from the FDA summary) - K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013) Summary page 6. - K140082: Aequalis (TM) Ascent (TM) Flex Shoulder System, Tornier S.A.S. (2014) Summary page 6. - K030941: 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. - K100142: Aequalis Reversed Shoulder Prosthesis, Tornier (2010) Summary page 6. - K132285: Aequalis Reversed Shoulder Prosthesis, Tornier S.A.S. (2013) Summary page 6. - K140478: Aequalis Reversed Shoulder Prosthesis, Tornier S.A.S. (2014) Summary page 6. - K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 6. - K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 6. - K092873: Reverse Shoulder Prosthesis, Djo Surgical (2009) Summary page 6. - K112069: RSP Glenoid Baseplate Porous Coated, Encore Medical L.P. (2011) Summary page 6. - K140904: RSP Monoblock Stem with P2 Coating, Size 6, Encore Medical L.P. (2014) Summary page 6. ## Most influential descendants - 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 - K212800: PRIMA Humeral System and SMR Glenosphere Ø42 (2022), 2 descendants of its own ## Indications for use SYSTEM INTENDED USE: The Aequalis Ascend Flex Shoulder System is intended for use as: « A replacement of shoulder joints in primary anatomic or in primary reverse. * A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. * The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision. IN ANATOMIC : The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by: * Rheumatoid arthritis with pain * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) * Correction of functional deformity * Fractures of the humeral head * Traumatic arthritis * Revision of other devices if sufficient bone stock remains IN REVERSE: The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: - Rheumatoid arthritis - Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - Revision of the devices if sufficient bone stock remains. The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear, Notes: - all components are single use. - the coated humeral stem is intended for cemented or cementless use, - the non-coated humeral stem is for cemented use only. - the all-poly glenoid components are intended for cemented use only. - the glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation. - Titanium humeral heads are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack a suspected material sensitivity to cobalt alloy. Device Name: Aequalis Reversed Shoulder Prosthesis 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 uncemented 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 in to 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. Note: - Titanium glenoid spheres are intended for patients with suspected cobalt alloy material sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium glenoid sphere is not recommended for patients who lack a suspected material sensitivity to cobalt alloy. Source page: https://510kreport.com/device/K151293 Methodology: https://510kreport.com/methodology