Arthrex Univers Revers Shoulder Prosthesis System

K161782 · Arthrex, Inc. · HSD · Nov 21, 2016 · Orthopedic

Device Facts

• Record ID: K161782
• Device Name: Arthrex Univers Revers Shoulder Prosthesis System
• Applicant: Arthrex, Inc.
• Product Code: HSD · Orthopedic
• Decision Date: Nov 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3690
• 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 rotator cuff deficiency. (Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

Device Story

The Arthrex Univers Revers Shoulder Prosthesis System is a modular shoulder replacement implant system. It consists of humeral stems and humeral suture cups, designed as a line extension to existing systems. The device is implanted by an orthopedic surgeon in a clinical/surgical setting to replace a damaged glenohumeral joint. The system functions by providing a mechanical replacement for the joint, specifically designed for cases with rotator cuff deficiency, relying on the patient's deltoid muscle for function. The humeral stems are available in various sizes and are designed for cemented or cementless application. The glenoid baseplate features a CaP coating for cementless fixation with screws. The device aims to relieve pain and restore function in patients with severe shoulder arthropathy or failed prior replacements.

Clinical Evidence

Bench testing only. Dynamic fatigue testing was conducted on humeral stems and suture cups, with all constructs surviving 10 million cycles under compression and torsion loading. Abrasion testing was performed on the new suture cups, demonstrating resistance exceeding that of the predicate device.

Technological Characteristics

Modular shoulder prosthesis system. Humeral stems (sizes 5-15) and humeral suture cups. Glenoid baseplate features CaP (calcium phosphate) coating for cementless fixation. Designed for cemented or cementless application. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients with grossly rotator cuff deficient glenohumeral joints, severe arthropathy, or failed joint replacements with gross rotator cuff deficiency. Requires anatomically/structurally suited joints and functional deltoid muscle. Used for primary, fracture, or revision total shoulder replacement to relieve pain and disability.

Regulatory Classification

Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

Predicate Devices

• Arthrex Univers Revers Shoulder Prosthesis System (K130129/K142863)

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 21, 2016

Arthrex, Inc. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Blvd. Naples, Florida 34108-1945

Re: K161782

Trade/Device Name: Arthrex Univers Revers Shoulder Prosthesis System Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD, PHX Dated: October 19, 2016 Received: October 20, 2016

Dear David L. Rogers:

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 devicerelated 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.

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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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

K161782

510(k) Number (if known)

Device Name Arthrex Univers 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 rotator cuff deficiency.

(Humeral) Stems are intended for cementless applications for use with Arthrex Humeral Suture Cups. 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)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510K SUMMARY OF SAFETY AND EFFECTIVENESS

| Date Summary Prepared | November 21, 2016 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/<br>Distributor/<br>Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | David L Rogers<br>Project Manager, Regulatory Affairs<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 71924<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Univers Revers Shoulder Prosthesis System |
| Common Name | Shoulder Prosthesis |
| Product Code, | HSD – Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis, CFR<br>888.3690 |
| Classification Name, CFR | PHX - Shoulder joint metal/polymer semi-constrained cemented prosthesis, CFR 888.3660 |
| Predicate Device | K130129/K142863: Arthrex Univers Revers Shoulder Prosthesis System |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance for the<br>Arthrex Univers Revers Humeral Stems and Suture Cups as a line extension to the Arthrex<br>Univers Revers Shoulder Prosthesis System. |
| Device Description | The Arthrex Univers Revers Humeral Stems and Suture Cups is a line extension to the<br>Arthrex Univers Revers Shoulder Prosthesis System. The proposed humeral stems, sizes 6<br>thru 15, are modified versions of the humeral stems cleared under K130129/K142863 and<br>are designed to be shorter in medial to lateral width. The line extension also introduces a<br>size 5 modular stem as well as modified versions of the Humeral Suture Cups. |
| Intended Use | The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff<br>deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement<br>with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally<br>suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use<br>the device. |
| | The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision<br>total shoulder replacement for the relief of pain and significant disability due to rotator cuff<br>deficiency. |
| | (Humeral) Stems are intended for cemented or cementless applications for use with Arthrex<br>Humeral Suture Cups. The glenoid baseplate is CaP coated and is intended for cementless<br>use with the addition of screws for fixation. |
| Substantial<br>Equivalence Summary | The Arthrex Univers Revers Humeral Stems and Suture Cups are substantially equivalent to<br>the predicate devices, in which the fundamental scientific technology and intended use are<br>the same. Any differences between the Arthrex Univers Revers Humeral Stems and Suture<br>Cups and the predicate are considered minor and do not raise questions concerning safety<br>and effectiveness. |
| | Dynamic fatigue testing was performed to evaluate the fatigue resilience of the proposed<br>Univers Revers Humeral Stems and Humeral Suture Cups. All constructs survived 10 million<br>cycles for both compression and torsion loading conditions. Abrasion testing was also<br>performed to assess the risk of suture abrasion using the new Humeral Suture Cups.<br>Abrasion resistance exceeded the predicate. |
| | Based on the indication for use, technological characteristics, and the summary of data<br>submitted, Arthrex, Inc. has determined that the Arthrex Univers Revers Shoulder Prosthesis<br>System is substantially equivalent to currently marketed predicate device. |