The ReUnion RSA Shoulder System 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 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.

Device Description

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 Cup, Humeral Insert, Glenoid Baseplate, Center Screw, Peripheral Screws and Glenosphere. 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. The ReUnion RSA Shoulder System components are indicated for primary reverse shoulder or revision reverse shoulder replacement procedures having gross rotator cuff deficiency.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ReUnion RSA Shoulder System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria in terms of clinical performance or algorithm accuracy.

Therefore, the requested information, which is typically associated with studies demonstrating the performance of diagnostic algorithms or standalone software, cannot be found in this document.

Specifically, the document states:

"Clinical Testing: Clinical testing was not required for this submission." (Page 5)

This means there is no study presented in this 510(k) that evaluates the device's clinical performance against specific acceptance criteria in the manner requested. The document primarily focuses on non-clinical testing (e.g., fatigue strength, micromotion) to demonstrate substantial equivalence in design and materials to predicate devices.

As such, I cannot populate the table or answer the specific questions about acceptance criteria, reported performance, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details. This information is simply not part of a 510(k) for a physical implantable device like a shoulder system, especially when clinical testing is explicitly stated as not required.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2016

Stryker Corporation Ms. Estela Celi Regulatory Affairs Specialist 325 Corporate Drive Mahwah. New Jersey 07430

Re: K130895

Trade/Device Name: ReUnion RSA Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS Dated: November 15, 2013 Received: November 18, 2013

Dear Ms. Celi:

This letter corrects our substantially equivalent letter of December 27, 2013.

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Estela Celi

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

K130895 510(k) Number (if known):

..............................................................................................................................................................................

Device Name: ReUnion RSA Shoulder System

Indications for Use:

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.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey if the may Division Bron

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K130895 .

510(k) Summary

Proprietary Name:	ReUnion RSA Shoulder System
Common Name:	Shoulder Prosthesis
Classification Name and Reference:	Shoulder joint metal/polymer semi-constrained cementedprosthesis 21 CFR §888.3660
Regulatory Class:	Class II
Product Codes:	KWS
For Information contact:	Estela Celi, Regulatory Affairs SpecialistStryker Trauma AG325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6461 Fax: (201) 831-3461estela.celi@stryker.com
Alternate Contact:	Karen AriemmaHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5718 Fax: (201) 831-4718karen.ariemma@stryker.com
Date Prepared:	March 28, 2013
	Legally Marketed Device to Which Substantial Equivalence is Claimed:

K080642 & K072804-Comprehensive Reverse Shoulder (Biomet) .

K112069- Reverse Shoulder System (DJO Encore) ●
K081171-Tritanium Acetabular Shell (Howmedica Osteonics) .
K062250-Delta Xtend Reverse Shoulder System (DePuy) ●
. K021478-Delta Shoulder (DePuy)

Description :

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the ReUnion RSA Shoulder System. 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 Cup, Humeral Insert, Glenoid Baseplate, Center Screw, Peripheral Screws and Glenosphere. The Humeral Cup with the Humeral Insert are attached to

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K130895

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. The ReUnion RSA Shoulder System components are indicated for primary reverse shoulder or revision reverse shoulder replacement procedures having gross rotator cuff deficiency.

Intended Use:

Indications:

The ReUnion RSA Shoulder System in 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 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.

Summary of Technologies:

Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices. The following differences exist between the subject and predicate devices.

. Both the Reverse Shoulder System and the ReUnion RSA Shoulder System subject device contain two taper junctions. The Comprehensive Reverse Shoulder contains an additional taper present in the taper adaptor between the Glenosphere and Glenoid Baseplate.
The Comprehensive Reverse Shoulder contains a post as well as Center Screw to fix the ● Glenoid Baseplate to the glenoid bone. Both the ReUnion RSA Shoulder System and the Reverse Shoulder System contain only a Center Screw.

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K130895

Non-Clinical Testing:

Non-clinical laboratory testing was performed for the ReUnion RSA Shoulder System components to determine substantial equivalence. Testing and evaluations demonstrated that the subject device is substantially equivalent to devices currently cleared for marketing. The testing/analysis included the following:

. Fatigue Strength Testing
Micromotion Testing .
Engineering, Literature, and MAUDE Analysis of Fretting in the Shoulder Joint .
Glenoid Baseplate Substrate and Coating Characterization ●
. Static Testing of the humeral Insert/humeral cup junction
Disassembly testing of the glenosphere/glenoid baseplate connection. .
. Evaluation of Range of Motion

Clinical Testing: Clinical testing was not required for this submission.

Conclusion: The ReUnion RSA Shoulder System is substantially equivalent to the predicate devices identified in this premarket notification.

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.”