UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM

K130129 · Arthrex, Inc. · KWS · May 31, 2013 · Orthopedic

Device Facts

• Record ID: K130129
• Device Name: UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
• Applicant: Arthrex, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: May 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Univers Revers Shoulder Prosthesis is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation. The uncoated cup and stem are intended for cemented use, all other components are for cementless use only.

Device Story

Reverse shoulder prosthesis system; inverted articular design compared to traditional total shoulder arthroplasty. Components: titanium humeral stem/epiphysis (uncoated or CaP coated), titanium spacer, UHMWPE humeral cup liner, TPS/CaP coated titanium glenoid baseplate, cobalt chrome glenosphere, titanium screws. Used in orthopedic surgery; implanted by surgeons to replace damaged glenohumeral joint. Provides mechanical joint stability in patients with rotator cuff deficiency; relies on deltoid muscle function for movement. Benefits: restores joint function and reduces pain in patients unsuitable for standard anatomical shoulder replacement.

Clinical Evidence

Bench testing only; no clinical data provided. Mechanical testing demonstrated fatigue strength substantially equivalent to predicate devices.

Technological Characteristics

Materials: Titanium, cobalt chrome, UHMWPE, CaP coating, TPS coating. Design: Reverse shoulder prosthesis (inverted articular geometry). Fixation: Cemented (uncoated cup/stem) or cementless (baseplate with screws).

Indications for Use

Indicated for patients with grossly rotator cuff deficient glenohumeral joints, severe arthropathy, or failed prior joint replacement with gross rotator cuff deficiency. Requires anatomically/structurally suitable joint and functional deltoid muscle.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Zimmer Anatomical Shoulder System (K053274)
• Torneir Aequalis Revers Shoulder Prosthesis (K100142)

Submission Summary (Full Text)

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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

Arthrex. Incorporated Ms. Courtney Smith Regulatory Affairs Manager 1370 Creekside Boulevard Naples, Florida 34108

Re: K130129

Trade/Device Name: Univers Revers Shoulder Prosthesis 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: April 29, 2013 Received: May 1, 2013

Dear Ms. Smith:

This letter corrects our substantially equivalent letter of May 31, 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. Iisting 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. Courtney Smith

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.

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 [phone] or [phone] 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 [phone] or [phone] 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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## 1 INDICATIONS FOR USE

## Indications for Use

510(k) Number (if known): K130129

Arthrex Univers Revers Shoulder Prosthesis System Device Name:

Indications For Use:

The Univers Revers Shoulder Prosthesis is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

The uncoated cup and stem are intended for cemented use, all other components are for cementless use only.

> AND/OR Over-The-Counter Use Prescription 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 Evaluation (ODE)

PAGE 1 of 1

Casey L. Hanley, Ph.D

Division of Orthopedic-Devices

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K130129 (1/2)

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## MAY 3 1 2013
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| 2.2.510(K) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared | January 9, 2013 |
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 USA |
| 510(k) Contact | Courtney Smith |
| | Regulatory Affairs Manager |
| | Arthrex, Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 USA |
| | Telephone: [phone], ext. 1720 |
| | Fax: [phone] |
| | Email: [e-mail] |
| Trade Name | Univers Revers Shoulder Prosthesis System |
| Common Name | Shoulder Prosthesis |
| Product Code -Classification Name | KWS - Prosthesis, Shoulder, semi-constrained |
| CFR | metal/polymer, cemented, CFR 888.3660 |
| Predicate Device | K053274: Zimmer Anatomical Shoulder System |
| | K100142: Torneir Aequalis Revers Shoulder Prosthesis |
| Purpose of Submission | This traditional 510(k) premarket notification is |
| | submitted to obtain clearance for the Univers Revers |
| | Shoulder Prosthesis System. |
| Device Description | The Arthrex Univers Revers Shoulder Prosthesis System<br>has an articular design that is inverted compared to |
| | traditional total shoulder prosthesis. The system is |
| | comprised of two main components; the Arthrex Univers |
| | Revers Shoulder Prosthesis and the Universal Glenoid |
| | Shoulder Prosthesis. The Arthrex Univers Revers |
| | Shoulder Prosthesis is a titanium humeral stem and |
| | epiphysis or humeral cup, a titanium spacer, and an<br>UHMWPE humeral cup liner. The humeral stem and |
| | epiphysis are available uncoated or with CaP coating. The |
| | Universal Glenoid Shoulder Prosthesis consists of a |
| | TPS/CaP coated titanium glenoid baseplate, a cobalt |
| | chrome glenosphere, and titanium screws. |
| <b>Intended Use</b> | The Univers Revers Shoulder Prosthesis is indicated for<br>use in a grossly rotator cuff deficient glenohumeral joint<br>with severe arthropathy or a previous failed joint<br>replacement with gross rotator cuff deficiency. The<br>patient's joint must be anatomically and structurally<br>suited to receive the selected implant(s), and a functional<br>deltoid muscle is necessary to use the device.<br><br>The glenoid baseplate is CaP coated and is intended for<br>cementless use with the addition of screws for fixation.<br><br>The uncoated cup and stem are intended for cemented<br>use, all other components are for cementless use only. |
| <b>Substantial Equivalence Summary</b> | The Univers Revers Shoulder Prosthesis System is<br>substantially equivalent to the predicate devices in which<br>the basic features and intended uses are the same. Any<br>differences between the Univers Revers Shoulder<br>Prosthesis System and the predicates are considered<br>minor and do not raise questions concerning safety and<br>effectiveness. |
| | The proposed shoulder devices are substantially<br>equivalent to the predicate devices in regards to its<br>intended use, design, size ranges, and materials. |
| | The submitted mechanical testing data demonstrated<br>that the fatigue strength of the proposed devices is<br>substantially equivalent to the fatigue strength of the<br>predicate devices. The mechanical data indicate that the<br>Univers Revers Shoulder Prosthesis System is adequate<br>for their intended use. Clinical data and conclusions are<br>not needed for this device. |
| | Based on the indication for use, technological<br>characteristics, and the comparison to the predicate<br>devices, Arthrex, Inc. has determined that the Univers<br>Revers Shoulder Prosthesis System is substantially<br>equivalent to currently marketed predicate devices. |

Y 3 1 201.

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K130129 (2/2)

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