Integra TITAN Reverse Shoulder System

K173717 · Integra LifeSciences Corporation · PHX · Jun 21, 2018 · Orthopedic

Device Facts

• Record ID: K173717
• Device Name: Integra TITAN Reverse Shoulder System
• Applicant: Integra LifeSciences Corporation
• Product Code: PHX · Orthopedic
• Decision Date: Jun 21, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

Device Story

Semi-constrained total shoulder prosthesis; replaces glenohumeral joint in patients with rotator cuff deficiency. System comprises humeral stems, reverse bodies, poly liners, and glenoid baseplate with central compression screw and peripheral screws. Glenosphere attaches to baseplate via taper lock. Used by orthopedic surgeons in clinical settings for total shoulder arthroplasty. Provides stable fixation and proximal bone loading; restores joint function and relieves pain. Modification involves changing implant baseplate and body coating from vacuum-sintered titanium Asymmatrix to titanium plasma spray.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical performance testing, including dynamic evaluation of glenoid component loosening/disassociation and fatigue testing.

Technological Characteristics

Semi-constrained shoulder prosthesis. Materials: metal/polymer. Glenoid baseplate secured with central compression screw and peripheral screws. Humeral stem (cemented/uncemented) and body (cementless). Coating: titanium plasma spray. No software or electronic components.

Indications for Use

Indicated for patients with grossly deficient rotator cuff joints, severe arthropathy, or failed previous joint replacements. Requires anatomically/structurally suitable joints and functional deltoid muscle. Indicated for primary, proximal humeral fracture, or revision total shoulder replacement to relieve pain and disability.

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

• Integra TITAN Reverse Shoulder System (K161189)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

Integra LifeSciences Corporation Blesson Abraham Sr. Regulatory Affairs Associate 8700 Cameron Road Suite 100 Austin, Texas 78754

June 21, 2018

Re: K173717

Trade/Device Name: Integra TITAN Reverse Shoulder 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: December 4, 2017 Received: December 5, 2017

Dear Mr. Abraham:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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# Page 2 - Blesson Abraham

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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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## Indications for Use

510(k) Number (if known)

### K173717

Device Name Integra TITAN Reverse Shoulder System

#### Indications for Use (Describe)

The TITAN Reverse Shoulder System is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Titan Reverse Shoulder System is indicated for primary, fractures including proximal humeral, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The glenoid base plate is intended for cementless application with the addition of screws for fixation. The humeral stem is indicated for cemented or uncemented use and the humeral body component is intended for cementless use.

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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Integra Lifesciences Corporation – Special 510(k)
Integra TITAN Reverse Shoulder System – Coating Change

# Section 7: 510(k) Summary

| Sponsor | Integra Lifesciences Corp.<br>311 Enterprise Drive<br>Plainsboro, NJ 08536 |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Number | 1651501 |
| Point of Contact | Kathleen McGuire<br>Associate, Regulatory Affairs<br>609-936-7916<br>311 Enterprise Drive<br>Plainsboro, NJ 08536 |
| Date | December 4, 2017 |
| Trade Name | Integra TITAN Reverse Shoulder System |
| Common Name | Reverse Total Shoulder |
| Classification<br>Panel | Orthopedic |
| Classification | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Regulation | Class II (under 21 CFR 888.3660) |
| Product Code | PHX |
| Predicate Device | K161189: Integra TITAN Reverse Shoulder System |
| Device Description | The TITAN Reverse Total Shoulder System is a semi-constrained<br>total shoulder construct. The humeral components consist of humeral<br>stems, reverse bodies of varying heights, and humeral poly liners.<br>The poly liners are available in varying thicknesses and constraints to<br>achieve stability and offset of the glenohumeral joint. The variable<br>length reverse bodies and proximally-filling shape are designed to<br>accommodate the natural humeral geometry, providing stable fixation<br>as well as proximal bone loading. The glenoid components are<br>composed of a baseplate secured by a central compression screw and<br>four peripheral screws, two of which can be locked. A glenosphere is<br>attached to the baseplate via taper lock. Glenospheres are available in<br>varying offsets and lateralizations. The stems are intended for |
| Intended Use | The TITAN Reverse Shoulder System is indicated for use in a<br>grossly deficient rotator cuff joint with severe arthropathy or a<br>previous failed joint replacement with a grossly deficient rotator cuff<br>joint. The patient's joint must be anatomically and structurally suited<br>to receive the selected implants and a functional deltoid muscle is<br>necessary to use the device. The TITAN Reverse Shoulder System is<br>indicated for primary, fractures - including proximal humeral, or<br>revision total shoulder replacement for the relief of pain and<br>significant disability due to gross rotator cuff deficiency. The glenoid<br>base plate is intended for cementless application with the addition of<br>screws for fixation. The humeral stem is indicated for cemented or<br>uncemented use and the humeral body component is intended for<br>cementless use. |
| Comparison to<br>Predicate | The proposed device is the same as the predicate in terms of fit, form,<br>and function. The sole modification to the system is that the coating<br>on the implant baseplate and body has been changed from vacuum-<br>sintered titanium Asymmatrix™ to titanium plasma spray. |
| Nonclinical<br>Performance Data | The TITAN Reverse Shoulder System has undergone the following<br>performance testing to confirm the system's ability to perform under<br>anticipated clinical conditions.<br>1. Dynamic Evaluation of RSS Glenoid Component Loosening<br><i>or Disassociation</i><br>The glenoid component is as resistant to loosening,<br>disassociation of modular components, and dislocation as the<br>predicate.<br>2. Reverse Shoulder System Fatigue Test<br>The coating change has no effect on the implant fatigue<br>strength.<br>3. Evaluation of RSS Implant Titanium Plasma Spray Coating<br>The coating meets all acceptance criteria presented in the<br>FDA documents "Class II Special Controls Guidance:<br>Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-<br>Constrained Porous-Coated Uncemented Prosthesis" and<br>"Guidance for Industry on the Testing of Metallic Plasma<br>Sprayed Coatings on Orthopedic Implants to Support<br>Reconsideration of Postmarket Surveillance Requirements". |
| Clinical<br>Performance Data | Clinical performance data are not required to demonstrate substantial<br>equivalence to the predicate device, as there have been no changes to<br>fit, form, or function of the device. |
| Conclusions<br>Drawn from<br>Performance Data | The performance data demonstrate that the coating change does not<br>raise any new issues regarding the safety or effectiveness of the<br>TITAN Reverse Shoulder System, and the modified device is as safe<br>and effective as the predicate. |

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# Integra Lifesciences Corporation – Special 510(k)
Integra TITAN Reverse Shoulder System – Coating Change