Univers Rivers Shoulder Prosthesis System

K142863 · Arthrex, Inc. · PHX · Nov 25, 2014 · Orthopedic

Device Facts

• Record ID: K142863
• Device Name: Univers Rivers Shoulder Prosthesis System
• Applicant: Arthrex, Inc.
• Product Code: PHX · Orthopedic
• Decision Date: Nov 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a 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 Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. (Humeral) Stems are intended for cemented or cementless applications. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

Device Story

The Univers Revers Shoulder Prosthesis System is an inverted total shoulder arthroplasty implant designed to restore joint function in patients with rotator cuff deficiency. The system consists of a titanium humeral stem/epiphysis, a titanium spacer, an UHMWPE humeral cup liner, a TPS/CaP coated titanium glenoid baseplate, a cobalt chrome glenosphere, and titanium screws. The device is implanted by an orthopedic surgeon in a clinical/surgical setting. The inverted design shifts the center of rotation, allowing the deltoid muscle to compensate for the deficient rotator cuff, thereby relieving pain and restoring shoulder function. The humeral stems support both cemented and cementless fixation, while the glenoid baseplate utilizes cementless fixation with screws. The system is intended for primary, fracture, or revision cases.

Clinical Evidence

No clinical data or animal studies were required for this submission. Substantial equivalence is supported by mechanical testing comparisons to predicate devices and the established clinical history of the predicate devices for the requested indications.

Technological Characteristics

System components include titanium humeral stem/epiphysis, titanium spacer, UHMWPE humeral cup liner, TPS/CaP coated titanium glenoid baseplate, cobalt chrome glenosphere, and titanium screws. Designed for cemented or cementless humeral fixation and cementless glenoid fixation. Semi-constrained prosthesis.

Indications for Use

Indicated for patients with grossly rotator cuff deficient glenohumeral joints, severe arthropathy, or failed prior joint replacement requiring primary, fracture, or revision total shoulder arthroplasty. 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)
• Arthrex Univers Revers Prosthesis Shoulder System (K130129)

Reference Devices

• Tornier Aequalis (K130129)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are the most prominent element of the logo.

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

November 25, 2014

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

Re: K142863

Trade/Device Name: Universe 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 Dated: September 30, 2014 Received: October 1, 2014

Dear Ms. Smith:

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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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ResourcesforYou/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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### 2.3 INDICATIONS FOR USE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K142863

Device Name

#### Universe Revers Shoulder Prosthesis System

Indications for Use (Describe)

The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a 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 Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

(Humeral) Stems are intended for cemented or cementless applications. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary of Safety and Effectiveness

| Date Summary Prepared | November 24, 2014 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc |
| | 1370 Creekside Blvd. |
| | Naples, FL |
| 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<br>CFR | PHX - Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis, CFR 888.3660 |
| Predicate Device | K053274: Zimmer Anatomical Shoulder System |
| | K130129: Arthrex Univers Revers Prosthesis Shoulder System |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to include a<br>fracture indication for the Univers Revers Shoulder Prosthesis System |
| Device Description | The Arthrex Univers Revers Shoulder Prosthesis System has an articular<br>design that is inverted compared to traditional total shoulder prosthesis.<br>The system is comprised of two main components; the Arthrex Univers<br>Revers Shoulder Prosthesis and the Universal Glenoid Shoulder Prosthesis.<br>The Arthrex Univers Revers Shoulder Prosthesis is a titanium humeral stem<br>and epiphysis or humeral cup, a titanium spacer, and an UHMWPE humeral<br>cup liner. The humeral stem and epiphysis are available uncoated or with<br>CaP coating. The Universal Glenoid Shoulder Prosthesis consists of a<br>TPS/CaP coated titanium glenoid baseplate, a cobalt chrome glenosphere,<br>and titanium screws. |
| Intended Use | The Univers Revers Shoulder Prosthesis is indicated for use in a grossly<br>rotator cuff deficient glenohumeral joint with severe arthropathy or a<br>previously failed joint replacement with a gross rotator cuff deficiency. The<br>patient's joint must be anatomically and structurally suited to receive the<br>selected implant(s), and a functional deltoid muscle is necessary to use the<br>device.<br>The Univers Revers Shoulder Prosthesis is indicated for primary, fracture,<br>or revision total shoulder replacement for the relief of pain and significant<br>disability due to gross rotator cuff deficiency. |
| | (Humeral) Stems are intended for cemented or cementless applications.<br>The glenoid baseplate is CaP coated and is intended for cementless use<br>with the addition of screws for fixation. |
| Substantial Equivalence Summary | The Univers Revers Shoulder Prosthesis System is substantially equivalent<br>to the predicate devices in which the basic features and intended uses are<br>the same. Any differences between the Univers Revers Shoulder Prosthesis<br>System and the predicates are considered minor and do not raise questions<br>concerning safety and effectiveness. |
| | The proposed shoulder devices are substantially equivalent to the predicate<br>devices in regards to its intended use, design, size ranges, and materials. |
| | Mechanical testing of the Univers Revers Shoulder Prosthesis System was<br>conducted and the results of this testing was compared to both the Zimmer<br>Anatomical Revers Shoulder System and the Tornier Aequalis in K130129.<br>No significant changes have been made to the Univers Revers Shoulder<br>Prosthesis System, which would affect performance of the device. The<br>Zimmer Anatomical Revers Shoulder System (K053274) is cleared with the<br>fracture indication; therefore no further performance testing is necessary<br>to add the fracture indication to the Univers Revers Shoulder Prosthesis<br>System. |
| | Additional Performance testing, animal studies and clinical data and<br>conclusions are not needed for this device. |
| | Based on the indication for use, technological characteristics, and the<br>comparison to the predicate devices, Arthrex, Inc. has determined that the<br>Univers Revers Shoulder Prosthesis System is substantially equivalent to<br>currently marketed predicate devices. |

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