INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid

K152047 · Ascension Orthopedics · KWS · Dec 23, 2015 · Orthopedic

Device Facts

• Record ID: K152047
• Device Name: INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
• Applicant: Ascension Orthopedics
• Product Code: KWS · Orthopedic
• Decision Date: Dec 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is intended for use in Total Shoulder Arthroplasty which is indicated for: 1. Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. Fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory. 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component) The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.

Device Story

The Integra Titan Modular Total Shoulder System Fin-Lock Glenoid is a prosthetic component for total shoulder arthroplasty. It consists of a highly cross-linked ultra-high-molecular-weight polyethylene (UHMWPE) glenoid component featuring one central barbed peg and three peripheral pegs. The device is designed to resurface the glenoid fossa and is intended for cemented fixation. It is used by orthopedic surgeons in a clinical/surgical setting to replace damaged joint surfaces. By providing a stable, articulated surface, the device aims to restore joint function and alleviate pain in patients with severe arthritis or complex fractures. The device is part of the broader Titan Modular Shoulder System and is compatible with existing humeral components.

Clinical Evidence

Bench testing only. Performance testing included rocking and subluxation characterization, glenoid pull-out fixation testing, and material characterization/wear testing of the cross-linked UHMWPE. All tests met acceptance criteria.

Technological Characteristics

Highly cross-linked UHMWPE glenoid component; central barbed peg and three peripheral pegs; cemented fixation; modular design compatible with Titan Modular Shoulder System; dimensions consistent with existing Titan three-peg inline glenoids.

Indications for Use

Indicated for patients with severely painful/disabled shoulder joints due to osteoarthritis, traumatic arthritis, or rheumatoid arthritis; proximal humerus fracture-dislocations with severe comminution or vascular compromise; or complex cases where arthrodesis/resection is unacceptable (e.g., revision). Glenoid component for cemented use only.

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

• Ascension® TITAN™ Modular Total Shoulder System Glenoid (K100448)

Reference Devices

• DePuy Anchor Peg Glenoid (K052472)
• Tornier Affiniti Glenoid (K103007)

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

December 23, 2015

Integra LifeSciences Corporation Mr. William Garzon Senior Regulatory Affairs Specialist 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K152047

Trade/Device Name: INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: November 24, 2015 Received: November 27, 2015

Dear Mr. Garzon:

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

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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,

Casey Hanley -S

- Mark 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) K152047

Device Name

INTEGRA® TITAN™M Modular Total Shoulder System Fin-Lock™ Glenoid

Indications for Use (Describe)

The INTEGRA® TITAN™ Modular System Fin-Lock™ Glenoid is intended for use in Total Shoulder Arthroplasty which is indicated for:

1. Severely painful and/or disabled joint resulting from osteoarthritis or rheumatoid arthritis.

2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory.

3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. – revision of a failed primary component)

The humeral component is intended for cemented or uncemented use.

The glenoid component is intended for cemented use only.

Type of Use (Select one or both, as applicable)

| <span style="text-decoration: overline;">☒</span> Transportation Use in CFR 229.301(a) | ☐ For Other Use in CFR 229.301(a) |
|----------------------------------------------------------------------------------------|-----------------------------------|
|----------------------------------------------------------------------------------------|-----------------------------------|

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 807.92(a)(1) – Submitter Information | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Integra LifeSciences Corporation |
| Address | 311 Enterprise Drive<br>Plainsboro NJ 08536 |
| Name of Contact Person | William Garzon |
| Phone Number | [phone] |
| Fax Number | [phone] |
| Establishment<br>Registration Number | 1651501 |
| Date Prepared | December 22, 2015 |
| 807.92(a)(2) – Name of device | |
| Trade or Propriety Name | INTEGRA® TITAN™ Modular Total Shoulder System Fin-<br>Lock™ Glenoid |
| Common or Usual Name | Shoulder Joint Metal/Polymer Semi-Constrained Cemented<br>Prosthesis |
| Classification Name | Prostheses, Shoulder, Semi-Constrained, Metal/Polymer<br>Cemented |
| Classification Panel | Orthopedic |
| Regulation | Class II (under 21CFR 888.3660) |
| Product Code | KWS |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| • | Ascension® TITAN™ Modular Total Shoulder System Glenoid (K100448) –<br>Primary Predicate |
| • | DePuy Anchor Peg Glenoid (K052472) – Reference Device |
| • | Tornier Affiniti Glenoid (K103007) – Reference Device |
| 807.92(a)(4) - Device description | |
| The Integra TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is a fully<br>cemented all highly cross-linked polyethylene glenoid used in total shoulder arthroplasty<br>for resurfacing the glenoid fossa. The glenoid component has one central peg with barbs<br>and three peripheral pegs. The articulating surface of the glenoid device will be the same<br>dimensions and sizes as existing Titan Modular Total Shoulder System three peg inline<br>glenoids for consistent mismatching. The Fin-Lock™ Glenoid is intended to be a part of<br>the TITAN™ Modular Shoulder System, 2.5 (K142413) and be used with the humeral<br>component. | |
| 807.92(a)(5) – Intended Use of the device | |
| Indications for Use | The INTEGRA® TITAN™ Modular Total Shoulder System Fin-<br>Lock™ Glenoid is intended for use in Total Shoulder Arthroplasty<br>which is indicated for:<br>1. Severely painful and/or disabled joint resulting from<br>osteoarthritis, traumatic arthritis or rheumatoid arthritis.<br>2. Fracture dislocations of the proximal humerus where the |
| | articular surface is severely comminuted, separated from its<br>blood supply or where the surgeon's experience indicated<br>that alternative methods of treatment are unsatisfactory.<br>3. Other difficult clinical problems where shoulder<br>arthrodesis or resection arthroplasty are not acceptable (e.g.<br>– revision of a failed primary component)<br>The humeral component is intended for cemented or uncemented<br>use.<br>The glenoid component is intended for cemented use only. |

### 510(k) Summary

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# 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate

The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is similar in design and materials to the predicate device, Ascension® TITAN™Modular Total Shoulder System (K100448). The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid has similar indications for use, intended use and fundamental scientific technology as its predicate.

The INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is similar in central peg length to the predicate devices, DePuy Anchor Peg Glenoid (K052472) and Tornier Affiniti Glenoid (K103007).

The differences between the predicates and proposed device do not raise any new issues regarding safety and effectiveness; therefore, the INTEGRA® TITAN™M Modular Total Shoulder System Fin-Lock™ Glenoid is considered substantially equivalent to the predicate device.

# 807.92(b)(1-2) – Nonclinical Tests Submitted

Testing to verify the performance of the INTEGRA® TITAN™ Modular Total Shoulder System Fin-lock™ Glenoid included the following:

- Rocking and Subluxation Characterization Test ●
- Glenoid Pull-out Fixation Test ●
- Extensively Cross-Linked UHMWPE Material Characterization Test ●
- Extensively Cross-Linked UHMWPE Wear Test

The results of these performance tests met their respective acceptance criteria and demonstrate that the INTEGRA® TITAN™ Modular Total Shoulder System Fin-Lock™ Glenoid is substantially equivalent to the predicate devices identified.

# 807.92(b)(3) - Conclusions drawn from non-clinical data

The design features, materials, intended use, and overall fundamental scientific technology of the INTEGRA® TITAN™ Modular Total Shoulder System are substantially equivalent to the predicate device. The safety and effectiveness of the INTEGRA® TITAN™ Modular Total Shoulder System is adequately supported by the substantial equivalence information, materials information, and performance data provided within this Premarket Notification submission.