The Reunion® TSA System components are sterile, single-use devices intended for use in primary and revision total shoulder arthroplasty to alleviate pain and restore function. The subject humeral stems will be offered in both cementless applications. The self pressurizing glenoid components are intended for cemented use only.

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 arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
Revision of previous unsuccessful total shoulder replacement, resurfacing or other . procedure.

The gleonid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.

Device Description

The subject Reunion® Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a modular neck adapter, single radius heads, and self pressurizing glenoids (SPG). The humeral stem components will be manufactured from titanium allov according to ASTM F136 and will be offered in both cemented and cementless designs. The cementless humeral stem design will feature a circumferential plasma spray and hydroxyapatite (HA) coating and be offered in 7mm-17mm distal diameters in 1mm increments. The cemented humeral stems will be offered in 6mm-15mm distal diameters in 1mm increments and will also include 4 longer stems with distal diameters 6mm-12mm in 2 mm increments. These humeral stems were designed to mate with the subject single radius heads or the modular neck adapter, manufactured from cobalt chrome according to ASTM F1537, for compatibility with other marketed humeral heads. The single radius heads will be manufactured from cobalt chrome according to ASTM F75 and will be offered in spherical diameter head sizes 40mm-56mm in 4mm increments for both standard and eccentric designs. The self pressuring glenoids (SPG) will be manufactured from X3% polyethylene according to ASTM F648 and will mate with the single radius heads. The SPGs will be offered in both pegged and keeled configurations ranging from 40mm-56mm spherical diameters in 4mm increments.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ReUnion® Total Shoulder Arthroplasty (TSA) System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new safety and effectiveness through clinical trials with specific acceptance criteria that a device must meet.

Therefore, many of the requested categories related to acceptance criteria, study design, and performance metrics for a novel medical device are not applicable (N/A) or not provided in this document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Testing (ASTM F2028-08):
Fatigue strength on humeral components met performance requirements.	Device met performance requirements.
Dynamic evaluation of glenoid loosening met performance requirements.	Device met performance requirements.
Clinical Performance:	No clinical testing provided as a basis for substantial equivalence.
Substantial Equivalence to Predicate Devices.	Demonstrated to be substantially equivalent to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: N/A (No clinical test set described in the 510(k) submission). Mechanical testing was performed. The specific number of samples for mechanical testing is not provided, only that it followed ASTM F2028-08.
Data Provenance: N/A (No clinical data provided). Mechanical testing data would be from laboratory experiments.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: N/A (No clinical test set or human-derived ground truth described).
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: N/A (No clinical test set requiring human adjudication described).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No (Not applicable for a shoulder arthroplasty system. This type of study is typically for diagnostic imaging AI devices).
Effect Size: N/A.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: N/A (The device is a physical shoulder implant, not a software algorithm or AI. The non-clinical testing refers to mechanical laboratory tests of the physical components).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Ground Truth: For the mechanical testing, the "ground truth" or standard was the performance requirements stipulated by ASTM F2028-08, demonstrating the device components' structural integrity and durability. For substantial equivalence, the "ground truth" is that the device's technological characteristics (material, design, sizes, and operational principles) are similar or identical to its predicate devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: N/A (No AI algorithm or related training set described).

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: N/A (No AI algorithm or related training set described).

Summary of the Study and Findings:

The study described is not a clinical study to establish new safety and effectiveness with defined clinical acceptance criteria. Instead, it is part of a 510(k) premarket notification process for a medical device (ReUnion® Total Shoulder Arthroplasty (TSA) System). The primary "study" components are:

Non-Clinical Laboratory Testing: Mechanical tests were performed according to ASTM F2028-08. These tests included:
- Fatigue strength on humeral components.
- Dynamic evaluation of glenoid loosening on the glenoids.
- The results demonstrated that the ReUnion® TSA system components met performance requirements and are considered "as safe and effective as their predicate devices" based on these mechanical properties.
Basis for Substantial Equivalence: The submission asserts substantial equivalence based on the technological characteristics (material, design, sizes, and operational principles) being "similar or identical" to the listed predicate devices.
Clinical Testing: None provided as a basis for substantial equivalence. The FDA concluded that the device is substantially equivalent based on the non-clinical testing and comparison to predicates.

Summary

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510(k) Summary (

Sponser:	Howmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430
Contact Person:	Avital Merl-MarguliesRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6365 Fax: (201) 831-3365
Date Prepared:	May 3, 2011
Proprietary Name:	ReUnion® Total Shoulder Arthroplasty (TSA) System
Common Name:	Artificial Shoulder Components
Classification Name	21 CFR §888.3660: Shoulder Joint Metal/Polymer SemiConstrained Cemented Prosthesis21 CFR §888.3690: Shoulder Joint Humeral (hemi-shoulder) metallic uncemented prosthesis
Proposed Regulatory Class:	Class II
Product Codes:	87KWS: Prosthesis, shoulder, semi-constrained,metal/polymer, uncemented87HSD: Prosthesis, shoulder, hemi-humeral, metallic,cemented
Legally marketed device to which substantial equivalence is claimed:
	Osteonics Shoulder Humeral Components: K955731
	Solar ReUnion Fracture Stem: K062113
	Osteonics All Polyethylene Glenoid Shoulder Component: K950521
	Osteonics All Polyethylene Glenoid Shoulder Component: K962082
	Solar Shoulder Offset Humeral Head: K001419
	Osteonics Solar Shoulder Humeral Bearing Head: K990598
	Depuy Global Advantage Shoulder, Global Advantage Humeral Stem, Global AdvantageEccentric Head: K992065
	Depuy Global Shoulder Crosslinked Glenoid: K052472
	DVO Extremity Solutions Total and Hemi Shoulder System: K060988

Device Description:
The subject Reunion® Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a

Page 1 of 3

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K103835

modular neck adapter, single radius heads, and self pressurizing glenoids (SPG). The humeral stem components will be manufactured from titanium allov according to ASTM F136 and will be offered in both cemented and cementless designs. The cementless humeral stem design will feature a circumferential plasma spray and hydroxyapatite (HA) coating and be offered in 7mm-17mm distal diameters in 1mm increments. The cemented humeral stems will be offered in 6mm-15mm distal diameters in 1mm increments and will also include 4 longer stems with distal diameters 6mm-12mm in 2 mm increments. These humeral stems were designed to mate with the subject single radius heads or the modular neck adapter, manufactured from cobalt chrome according to ASTM F1537, for compatibility with other marketed humeral heads. The single radius heads will be manufactured from cobalt chrome according to ASTM F75 and will be offered in spherical diameter head sizes 40mm-56mm in 4mm increments for both standard and eccentric designs. The self pressuring glenoids (SPG) will be manufactured from X3% polyethylene according to ASTM F648 and will mate with the single radius heads. The SPGs will be offered in both pegged and keeled configurations ranging from 40mm-56mm spherical diameters in 4mm increments.

Intended Use:

Indications for Use:

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 arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
Revision of previous unsuccessful total shoulder replacement, resurfacing or other . procedure.

The gleonid components are intended for cemented use only.

Summary of Technologies:

The technological characteristics (material, design, sizes, and operational principles) of the ReUnion® TSA System components are similar or identical to its predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The following mechanical tests were conducted according to ASTM F2028-08: Fatigue strength on humeral components and dynamic evaluation of glenoid loosening on the glenoids. The testing demonstrated that the ReUnion® TSA

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system components met performance requirements and are as safe and effective as their predicate devices.

Clinical Testing:

None provided as a basis for substantial equivalence

Conclusion

The ReUnion® TSA System is substantially equivalent to the predicate devices identified in this premarket notification.

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

Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

MAY - 5 2011

Re: K103835

Trade/Device Name: ReUnion® Total Shoulder Arthroplasty (TSA) System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: April 29, 2011 Received: May 2, 2011

Dear Ms. Merl-Margulies:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Avital Merl-Margulies

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance 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 vours.

Aig B. R h

Mark N. Melker Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K103835

Device Name: ReUnion® Total Shoulder Arthroplasty (TSA) System

For use as a Henii of Total Shoulder Replacement:

Aseptic necrosis of the humeral head o
Painful, disabling joint disease;of the shoulder resulting from: degenerative arthritis, o rheumatoid arthritis, or post-traumatic arthritis.
Proximal humeral fractures and/or dislocation. o
Clinical management problems where arthrodesis or alternative reconstructive techniques o are less likely to achieve satisfactory results.
Revision of previous unsuccessful total shoulder replacement, resurfacing or other o procedure.

The gleonid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.

Prescription Use(Part 21 CFR 801, Subpart D)	X
AND/OR	Over-The-Counter Use(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Page 1 of 1	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number	K103835

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.”