The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, 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 designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

Device Description

The Arthrex Univers II Shoulder Pegged Glenoid is manufactured in three sizes from UHMWPE. The glenoid articular (lateral) surface is concave and articulates with the humeral head of the Univers or Univers II humeral stems. The fixation (medial) surface is convex and is designed with three pegs for cement interdigitation fixation.

AI/ML Overview

The provided text describes the Arthrex Univers II Shoulder Pegged Glenoid, a shoulder prosthesis. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/ML performance.

This document is a 510(k) summary for a medical device (a shoulder prosthesis), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a clinical or AI/ML study. The determination of substantial equivalence for a non-AI/ML device typically relies on a comparison of design, materials, manufacturing processes, and intended use with a legally marketed predicate device, rather than quantitative performance metrics from a specific study against acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states: "The Arthrex Univers II Shoulder Pegged Glenoid is substantially equivalent to the predicate Arthrex Univers Shoulder Prosthesis in which the basic features and intended uses are the same. Any differences between the Arthrex Univers II Shoulder Pegged Glenoid and the predicate Arthrex Univers Shoulder Prosthesis or Univers II Shoulder Prosthesis are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new Arthrex Univers II Shoulder Pegged Glenoid is substantially equivalent to the currently marketed predicate device."

This indicates that the primary "proof" of meeting safety and effectiveness is through demonstrating substantial equivalence to an existing device, not through a new performance study with acceptance criteria as typically seen for AI/ML devices.

Summary

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K083435 (pg. 1 of 2)

JUN 26 2009

. .

Arthrex: SPECIAL: 510(li); Arthrex Univers II Shoulder Peagged Glenoid

510(Jk) Summary of Safety and Eilectiv

Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Sally FoustRegulatory Affairs Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1251Fax: 239/598.5508Email: sally.foust@arthrex.com
Trade Name	Arthrex Univers II Shoulder Pegged Glenoid
Common Name	Shoulder Prosthesis
Product Code -Classification Name	KWS - Prosthesis, Shoulder, semi constrainedmetal/polymer, cementedHSD - Prosthesis, Shoulder, hemi-humeral, metal,uncemented
Predicate Devices	Arthrex Univers II Shoulder Prosthesis, K071032Arthrex Univers Shoulder Prosthesis, K010124
Device Description and IntendedUse	The Arthrex Univers II Shoulder Pegged Glenoid ismanufactured in three sizes from UHMWPE. Theglenoid articular (lateral) surface is concave andarticulates with the humeral head of the Univers orUnivers II humeral stems. The fixation (medial) surface isconvex and is designed with three pegs for cementinterdigitation fixation.The Arthrex Univers II Shoulder Prosthesis is indicated inreplacements(s) when conditions include severe pain orsignificant disability resulting from degenerative,rheumatoid, traumatic disease, or injury of theglenohumeral joint; non-union humeral head fractures oflong duration; irreducible 2- and 4- part proximal humeralfractures; avascular necrosis of the humeral head; orother difficult clinical management problems wherearthrodesis or resectional arthroplasty is not acceptable.
	The glenoid components are designed for cementedfixation in the joint and must only be used with anappropriate.bone cement.
Substantial EquivalenceSummary	The Arthrex Univers II Shoulder Pegged Glenoid issubstantially equivalent to the predicate Arthrex UniversShoulder Prosthesis in which the basic features andintended uses are the same. Any differences betweenthe Arthrex Univers II Shoulder Pegged Glenoid and thepredicate Arthrex Univers Shoulder Prosthesis orUnivers II Shoulder Prosthesis are considered minor anddo not raise questions conceming safety andeffectiveness. Based on the information submitted,Arthrex, Inc. has determined that the new ArthrexUnivers II Shoulder Pegged Glenoid is substantiallyequivalent to the currently marketed predicate device.

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K083435 (pg. 2 of 2)

ArthreX SPECIAL 510gly): Arthrex Univers II Shoulder Peagged Glerioid

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Public Health Service

JUN 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrex, Incorporated % Ms. Sally Foust, RAC Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K083435

Trade/Device Name: Arthrex Univers II Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal-polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: May 29, 2009 Received: June 3, 2009

Dear Ms. Foust:

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.

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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Sally Foust, RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Harbay Mueller

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

Enclosure

K083435-Arthrex, Incorporated

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Arthrex SPECIAL 510(k): Airthrex Univers 11 Shoulder Regged Glenolds

Indications for Use

510(k) Number:

Device Name:

Arthrex Univers II Shoulder Prosthesis

K083435

The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include 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 4part 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 designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

Prescription Use_X_AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Byaluation (ODE)

PAGE 1 of 1

Charlae Burns

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083435

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.”