# K171841: Arthrex Shoulder System - Pathway: 510(k) (Traditional) - Applicant: Arthrex, Inc. - Decided: Mar 29, 2018 after 282 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: 14 generations back to K911686 (1991). 73 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 75 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K020345: Arthrex Univers Fracture Prosthesis, Arthrex, Inc. (2002) Summary page 8. - K071032: Arthrex Univers II Shoulder Prosthesis, Arthrex, Inc. (2007) Summary page 8. - K083435: Arthrex Univers II Shoulder Pegged Glenoid, Arthrex, Inc. (2009) Summary page 8. - K103466: Arthrex Univers II Shoulder Prosthesis, Arthrex, Inc. (2010) Summary page 8. - K120044: Arthrex Universii XL Glenoid-Pegged, Arthrex Univers II XL Glenoid-Keeled, Arthrex, Inc. (2012) Summary page 8. - K130129: Univers Revers Shoulder Prosthesis System, Arthrex, Inc. (2013) Summary page 8. - K130675: Arthrex Univers II CA Heads, Arthrex, Inc. (2013) Summary page 8. - K131633: Arthrex Univers Apex, Arthrex, Inc. (2013) Summary page 8. - K142863: Univers Rivers Shoulder Prosthesis System, Arthrex, Inc. (2014) Summary page 8. - K151527: Arthrex Univers Revers CA Heads and Adapters, Arthrex, Inc. (2016) Summary page 8. - K153115: Arthrex Univers Apex, Size 5 Stem, Arthrex, Inc. (2015) Summary page 8. - K161108: Arthrex VaultLock Glenoid, Arthrex, Inc. (2016) Summary page 8. - K161782: Arthrex Univers Revers Shoulder Prosthesis System, Arthrex, Inc. (2016) Summary page 8. - K172371: Arthrex UNIVERS REVERS COATED BASEPLATE, Arthrex, Inc. (2018). Our reading of the summary gave K173271, FDA’s number for Aesculap Slim Clip Applier Forceps (Aesculap, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Arthrex Revers Coated Baseplate”. ## Most influential descendants - K230366: Arthrex Univers Revers Monoblock Stem Size 4/33 (2023), 0 descendants of its own ## Indications for use The Arthrex UNIVERS REVERS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System. The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The Arthrex UNIVERS REVERS COATED BASEPLATE is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The Arthrex UNIVERS REVERS COATED BASEPLATE is coated and is intended for cementless use with the addition of screws for fixation. The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The Univers Revers Shoulder Prosthesis is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. (Humeral) Stems are intended for cemented or cementless applications for use with the Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation. The Arthrex Univers Revers CA Heads and Adapters are indicated for salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The Arthrex Univers Shoulder Fracture Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This included traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3-or4-fragment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck. The Arthrex Univers Shoulder Fracture Prosthesis is designed for cemented or non-cemented use. This device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place. The Arthrex UNIVERS II and UNIVERS APEX Shoulder Prosthesis is indicated in replacement(s) when conditions including severe pain or significant disability resulting from degenerative, theumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The glenoid components are intended for cemented fixation in the joint and must only be used with appropriate bone cement. Source page: https://510kreport.com/device/K171841 Methodology: https://510kreport.com/methodology