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generic background for product detail page Affinis Inverse shoulder replacement with vitamys glenosphere and ceramic liner

Affinis Inverse

Affinis Inverse provides a proven solution for reverse shoulder replacements, included in allergy cases. The unique vitamys-ceramic tribological pairing allows for a low wear rate 9 and durable prostheses.

Evolutionary

Inlay screw notching was eliminated by metaglene optimization to a two-peg design without an inferior screw. An increased impingement-free range of motion is achieved by a systematic glenosphere overhang and chamfered inlays – with an effective humeral stem inclination of 147°. [1]

Inverse

With an inversion of the materials in the tribological pairing, polyethylene abrasion at the scapular neck and the surrounding structures is eliminated.(2) This results in a reduced risk of polyethylene-induced diseases. [3-6]

Proven

Proven primary procedure with more than 15 years of clinical experience and strong clinical evidence. [7,8]

About

Affinis Inverse features an evolutionary design: in the Metaglene DP (Double Peg), inlay screw notching was eliminated by metaglene optimisation to a two-peg design without an inferior screw. An increased impingement-free range of motion is achieved by a systematic glenosphere overhang. A snap-in mechanism ensures a stable connection between metaglene and glenosphere. For more options in the treatment of larger defects or deformities, or in revision cases, the Metaglene CP (Central Peg) is ideal. A slightly stronger central press-fit peg in four lengths allows good primary stability even in difficult cases. The Affinis Inverse prosthesis convinces also on the humeral side with its evolutionary design with monolithic press-fit stems.

The Affinis Inverse shoulder system is defined by an evolutionary implant design as well as by use of progressive materials. These are vitamys, a highly crosslinked polyethylene enriched with vitaminE, for the glenosphere. The benefits of vitamys are obvious: The good mechanical strength allows long-term mechanical performance of the material. The high wear resistance reduces wear and thus the
risk of osteolyses. [4-6] The addition of vitamin E furthermore ensures resistance to oxidation and thus high resistance to ageing as well. [10]
Affinis Inverse features high-quality ceramics for the inlay liners, with low wear rates, high strength and toughness, good wettability as well as biologically inert behaviour.  [3, 10, 11] These advantages make the ceramics a treatment option not only for young and active patients.

A straightforward set concept and a smart instrumentation simplify the workflow during implantation. Furthermore, all surgical steps are instrument guided, thereby reproducible results can be achieved.


eIFU-Mathys and further documents available here

[1] de Wilde L F, Poncet D, Middernacht B, Ekelund A. Prosthetic overhang is the most effective way to prevent scapular conflict in a reverse total shoulder prosthesis. Acta Orthop. 2010;81(6):719-26. [2] Kohut G, Dallmann F, Irlenbusch U. Wear-induced loss of mass in reversed total shoulder arthroplasty with conventional and inverted bearing materials. J Biomech. 2012;45(3):469-73. [3] Alexander J J, Bell S N, Coghlan J, Lerf R, Dallmann F. The effect of vitamin E-enhanced cross-linked polyethylene on wear in shoulder arthroplasty-a wear simulator study. J Shoulder Elbow Surg. 2019. [4] Boileau P, Moineau G, Morin-Salvo N, Avidor C, Godeneche A, Levigne C, Baba M, Walch G. Metal-backed glenoid implant with polyethylene insert is not a viable long-term therapeutic option. J Shoulder Elbow Surg. 2015;24(10):1534-43. [5] Harris W H. Wear and periprosthetic osteolysis: the problem. Clin Orthop Relat Res. 2001(393):66-70. [6] Huang C H, Lu Y C, Chang T K, Hsiao I L, Su Y C, Yeh S T, Fang H W, Huang C H. In vivo biological response to highly cross-linked and vitamin e-doped polyethylene – a particle-Induced osteolysis animal study. J Biomed Mater Res B Appl Biomater. 2016;104(3): 561-7. [7] ODEP Rating: http://www.odep.org.uk/products.aspx, last access 21.01.2021. [8] Irlenbusch U, Kaab M, Kohut G, Proust J, Reuther F, Joudet T. Reversed shoulder arthroplasty with inversed bearing materials: 2-year clinical and radiographic results in 101 patients. Arch Orthop Trauma Surg. 2015;135(2):161-9. [9] Lerf R, Wuttke V, Reimelt I, Dallmann F, Delfosse D. Tribological Behaviour of the «Reverse» Inverse Shoulder Prosthesis. 7th International UHMWPE Meeting. Philadelphia 2015. [10] Willmann G. Improving Bearing Surfaces of Artificial Joints. Advanced Engineering Materials. 2001;2(3):135-41. [11] Barnes D H, Moavenian A, Sharma A, Best S M. Biocompatibility of Ceramics. ASM Handbook. 2012;23.

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Product manufactured by Mathys Ltd Bettlach

Please note that not all products are available and registered in every market. Please contact your Enovis’ Sales Representative for any further information.

Mathys Ltd Bettlach and Limacorporate S.p.A. are affiliates of Enovis Corporation.

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