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.

Device Description

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.

AI/ML Overview

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.

Summary

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September 3, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Stryker GmbH Jonathan Schell Sr. Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K210861

Trade/Device Name: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD, PHX Dated: August 4, 2021 Received: August 5, 2021

Dear Jonathan Schell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210861

Device Name ReUnion Reversible Fracture System (RFX)

Indications for Use (Describe)

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, or posttraumatic arthritis.
· Proximal humeral fractures and/or dislocation.
· Clinical management problems where arthrodesis or alternative 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 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

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grossly deficient rotator cuff with severe arthropathy 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.qov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known)

K210861

Device Name ReUnion Reverse Shoulder Arthroplasty System (RSA)

Indications for Use (Describe)

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 ouff with sever 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).

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known)

K210861

Device Name

ReUnion Total Shoulder Arthroplasty System (TSA)

Indications for Use (Describe) 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 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 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, 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.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{6}------------------------------------------------

510(k) Summary

Proprietary Name:	ReUnion Reversible Fracture System (RFX)ReUnion Reverse Shoulder Arthroplasty System (RSA)ReUnion Total Shoulder Arthroplasty System (TSA)
Common Name:	A Prosthesis, shoulder, semi-constrained, metal/polymercemented (21 CFR 888.3660)
	Prosthesis, Shoulder, Hemi-Humeral, Metallic Uncemented(21 CFR 888.3690)
Regulation Description:	Shoulder joint metal/polymer semi-constrained cementedprosthesis (21 CFR 888.3660)
	Shoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis (21 CFR 888.3690)
Regulation Number:	21 CFR 888.366021 CFR 888.3690
Product Code:	KWS, HSD, PHX
Device Class:	Class II
Sponsor:	Stryker GmbHBohnackerweg 12545 Selzach / Switzerland
Contact Person:	Jonathan Schell, RACSr. Staff Regulatory Affairs Specialist325 Corporate DriveMahwah, NJ 07430Phone: 484-889-5804Fax: 201-831-6500
Date Prepared:	March 22, 2021
Primary Predicate:	K202289: ReUnion Reversible Fracture System (RFX),ReUnion Reverse Shoulder Arthroplasty System (RSA),ReUnion Total Shoulder Arthroplasty System (TSA)
Additional Predicates:	K161742: Tornier Aequalis PerFORM Reversed, AequalisPerFORM+ Reversed Glenoid
	K080642: Zimmer Biomet Comprehensive Reverse Shoulder

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Reference Device:	Reference Device:

K190991: Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment

Description

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.

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Note: ReUnion TSA Humeral Stems include both standard length ReUnion TSA stems and shorter length ReUnion S stems.

Intended Use

The ReUnion RSA, TSA and RFX Systems are intended for shoulder arthroplasty.

Indications for Use

ReUnion Reversible Fracture System (RFX)

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

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• 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.

ReUnion Reverse Shoulder Arthroplasty System (RSA)

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).

ReUnion Total Shoulder Arthroplasty System (TSA)

For use as a Hemi or Total Shoulder Replacement

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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.

Summary of Technologies

A comparison of the Subject Device RSA Baseplate shows that the Subject Device is substantially equivalent to the Predicate Device regarding Intended Use, design, and operational principle. The modification to the Subject Device is to an additive manufacturing process.

Non-Clinical Testing

. The Subject Device biocompatibility profile is equivalent to the Reference Device regarding material formulation, processing, and sterilization.
The Subject Device sterilization method and parameters are equivalent to the Predicate Device. ●
. Fatigue (fatigue to failure testing), Taper Strength (Pullout, Torque Out, Torsional Fatigue Resistance), and Micromotion Tests were performed on the Subject Device and all acceptance criteria was fulfilled. Also, a particulate removal assessment was performed for the Subject Device.
Engineering rationales are provided to demonstrate equivalence of the Subject Device to the Predicate Device with respect to Fretting Corrosion, Range of Motion, and MRI Compatibility; and to show material and process equivalence of the Subject Device to the Reference Device.

Clinical Testing

Clinical testing was not required for this submission.

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The Subject Device RSA Baseplate has the same Intended Use and Indications for Use as the Predicate Device, and equivalent technological characteristics to the Predicate Device. Therefore, the information provided in this submission demonstrates substantial equivalence of the Subject Device to the Predicate Device.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”