Search Results

The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.

When used with ReUnion TSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion TSA Humeral and Glenoid components, is indicated for use as a Hemi or Total Shoulder Replacement:

• Aseptic necrosis of the humeral head.
• Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
• Proximal humeral fractures and/or dislocation.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
  In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural glenoid provides sufficient bone stock, ReUnion RFX humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty to a secondary total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion RFX humeral stems can be converted from a total or reverse shoulder arthroplasty to a hemiarthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.
  The glenoid components are intended for cemented use only.

When used with ReUnion RSA Humeral & Glenoid Components
The ReUnion RFX System, when used with ReUnion RSA humeral & glenoid components, is intended for primary, fracture, or revision total shoulder replacement. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).

• Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;
• Proximal humeral fractures
• Revisions of previously failed shoulder joint replacements
  In the case of revision, when ReUnion RFX humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty. In conjunction with ReUnion RSA humeral and glenoid components, ReUnion RFX humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthropathy or previously failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).
  Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.

The ReUnion RSA Shoulder System is intended for primary, fracture, or revision of total Shoulder replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically and structurally suited to receive the selected implant(s).

• Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis or rheumatoid arthritis.
• Proximal humeral fracture.
• Revision of previously failed shoulder joint replacement.
  Glenoid Baseplate components are intended for cementless use with the addition of screw fixation.
  The Humeral Stem components are intended for both cemented and cementless use.
  In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a reverse shoulder arthroplasty.
  In conjunction with ReUnion RSA humeral and glenoid components, ReUnion TSA humeral stems can be converted from a hemi or total shoulder arthroplasty to a reverse shoulder arthroplasty, as well as revised from an existing reverse shoulder arthroplasty to a secondary reverse shoulder arthroplasty, in treatment of a grossly deficient rotator cuff with severe arthroplasty failed joint replacement with a grossly deficient rotator cuff. The patient must have a functional deltoid muscle, and be anatomically and structurally suited to receive the implant(s).

For use as a Hemi or Total Shoulder Replacement

• Aseptic necrosis of the humeral head.
• Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or posttraumatic arthritis.
• Proximal humeral fracture and/or dislocation.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
  Glenoid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.
  In the case of revision, when ReUnion TSA humeral stems are well fixed, the system is indicated for conversion to a total shoulder arthroplasty. In conjunction with ReUnion TSA humeral and glenoid components, if the natural glenoid provides sufficient bone stock, ReUnion TSA humeral stems can be converted from a hemiarthroplasty to a total shoulder arthroplasty, as well as revised from an existing total shoulder arthroplasty to a secondary total shoulder arthroplasty. It is also indicated for conversion to a hemiarthroplasty. In conjunction with ReUnion TSA humeral components, ReUnion TSA humeral stems can be converted from a total or ReUnion RSA reverse shoulder arthroplasty to a hemiarthroplasty, as well as revised from an existing hemiarthroplasty to a secondary hemiarthroplasty, in treatment of previously failed shoulder arthroplasty cases where revision to a reverse shoulder arthroplasty is inappropriate.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market a modified device within the ReUnion RSA System. The modification is to:

• introduce the additively manufactured ReUnion RSA Baseplate glenoid component to the existing ReUnion Shoulder Platform. The additively manufactured RSA Baseplate consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The porous Tritanium® coating is designed to achieve biological fixation.
• The modification to the Subject Device also includes several minor design and dimensional modifications.
  The Subject Device RSA Baseplate has the same Intended Use and Indications for Use as the Predicate Device, and shares the same operative technique.

ReUnion Reversible Fracture System (RFX)
The ReUnion Reversible Fracture System consists of a humeral fracture stem component which may be used in conjunction with TSA or RSA humeral and glenoid components for conventional total shoulder arthroplasty or reverse shoulder arthroplasty. It may also be used in conjunction with TSA humeral components to articulate directly with the anatomic glenoid in a hemi-shoulder application. The device contains various number of suture holes. The stems have a female taper on the proximal end of the shaft to accept TSA and RSA Gleno-humeral components. It is designed to be used in cemented applications only.

ReUnion Reverse Shoulder Arthroplasty System (RSA)
The ReUnion RSA Shoulder System is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The system is comprised of a humeral insert, glenosphere, glenoid baseplate and screws. The Humeral Cup with the Humeral Insert are attached to the humeral side of the joint via the ReUnion TSA Humeral Stem while the Glenosphere is implanted with the Glenoid Baseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws.

ReUnion Total Shoulder Arthroplasty System (TSA)
The Reunion Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a modular humeral neck adapter, single radius humeral heads, and self-pressurizing glenoids (SPG). The humeral stem is offered in both cemented and cementless designs. The cementless humeral stem design features a circumferential Ti-plasma spray and hydroxyapatite (HA) coating at the proximal end and the cemented humeral stems have no coating at the proximal end. These humeral stems were designed to mate with the subject single radius humeral heads or the modular neck adapter, for compatibility with other marketed humeral heads. The self-pressuring glenoids (SPG) mate with the single radius heads. The SPGs are offered in both pegged and keeled configurations.

The provided text is a 510(k) Summary for medical devices, specifically orthopedic implants (shoulder arthroplasty systems). This type of document is used to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed performance studies of a novel AI/software medical device.

Therefore, the input document does not contain the information requested in points 1-9 regarding acceptance criteria and performance studies for an AI/software device. The document primarily focuses on explaining the device's indications for use, its components, and how it is substantially equivalent to existing predicate devices, particularly highlighting a modification to the RSA Baseplate involving an additive manufacturing process and emphasizing non-clinical tests for mechanical properties and biocompatibility.

Here's why the requested information is not present:

• Acceptance Criteria and Reported Device Performance (1): The document discusses non-clinical testing for fatigue, taper strength, and micromotion, stating "all acceptance criteria was fulfilled." However, it does not provide specific numerical acceptance criteria or detailed performance results in the format of a table as requested.
• Sample Size, Ground Truth, Adjudication (2, 3, 4, 7, 8, 9): These points relate to studies involving data sets, expert review, and ground truth establishment, which are typical for studies validating AI/software performance. This document clearly states, "Clinical testing was not required for this submission." This indicates that no studies involving human interpretation of data (which would require ground truth, experts, and adjudication) were performed for this 510(k) submission. The validation here is primarily on the physical and material characteristics of the orthopedic implant.
• MRMC Comparative Effectiveness Study (5): Since no clinical testing or human-in-the-loop studies were conducted, an MRMC comparative effectiveness study with or without AI assistance is not applicable and not discussed.
• Standalone Performance (6): Similarly, since this is a mechanical implant and not an AI algorithm, the concept of "standalone performance" for an algorithm is not applicable.

In summary, the provided FDA 510(k) document is for a physical orthopedic implant system, and its content focuses on demonstrating substantial equivalence through design comparisons, material characterization, and mechanical testing, rather than performance metrics related to an AI/software component as implied by the questions.

Ask a specific question about this device