Aequalis PerFORM+ Shoulder System

K160975 · Tornier, Inc. · KWS · Jun 10, 2016 · Orthopedic

Device Facts

• Record ID: K160975
• Device Name: Aequalis PerFORM+ Shoulder System
• Applicant: Tornier, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jun 10, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Tornier shoulder prostheses are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.

Device Story

Aequalis PerFORM+ Shoulder System is a modular total shoulder arthroplasty prosthesis; consists of metaphyseal humeral stem, anatomic humeral heads, and glenoid component. Used by orthopedic surgeons in clinical settings to replace diseased or damaged shoulder joints. Device components are implanted to restore joint function, reduce pain, and improve mobility. System includes specialized surgical instruments to facilitate implantation. Performance verified through mechanical bench testing (loosening, shear, tensile) and endotoxin testing. No clinical studies required for clearance.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing, including loosening, shear, and tensile pull-out tests, and endotoxin testing (≤ 20 EU/device).

Technological Characteristics

Modular shoulder prosthesis; components include metaphyseal humeral stem, anatomic humeral heads, and glenoid. Glenoids and monobloc stems are for cemented use; press-fit stems are for uncemented use. Mechanical fixation principle. No software or electronic components.

Indications for Use

Indicated for patients requiring prosthetic shoulder replacement to relieve severe pain or disability due to degenerative pathologies (arthrosis, rheumatoid arthritis, post-traumatic arthrosis), primary/secondary humeral head necrosis, displaced 4-part upper humeral fractures, humeral head fractures, or other conditions where arthrodesis/resectional arthroplasty are unacceptable. Also indicated for revision surgery. Glenoids are for cemented use; monobloc stems are for cemented use; press-fit stems are for uncemented use.

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

• Aequalis PerFORM+ Shoulder System (K150583)

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

June 10, 2016

Tornier, Incorporated Ms. Loucinda Biorklund Manager, Regulatory Affairs 10801 Nesbitt Avenue South Bloomington, Minnesota 55437

Re: K160975

Trade/Device Name: Aequalis PerFORM+ Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: May 10, 2016 Received: May 11, 2016

Dear Ms. Bjorklund:

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 Parts 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# 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

510(k) Number (if known) K160975

Device Name

Aequalis PerFORM+ Shoulder System

Indications for Use (Describe)

Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:

- · Degenerative pathologies: arthrosis, rheumatoid arthrosis, post traumatic arthrosis
- · Primary and secondary necrosis of the humeral head
- · Displaced 4-part upper humeral fracture
- · Humeral head fracture
- · Other pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- · Revision surgery when other treatments or devices have failed
- The Aequalis PerFORM+ glenoids are intended for cemented use only.

The Aequalis monobloc stem is for cemented use

The Aequalis Press-Fit is for uncemented 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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# 510(k) Summary K160975

#### I. Submitter

Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55437

| Date Prepared: | June 8, 2016 |
|-----------------------|---------------------------------------------------------------------------------------|
| Contact Person: | Loucinda Bjorklund |
| | Manager, Regulatory Affairs |
| Phone: | 952-683-7491 |
| Fax: | 952-426-7601 |
| II. | Device |
| Name of Device: | Aequalis PerFORM+ Shoulder System |
| Common or Usual Name: | Shoulder Prosthesis, humeral head |
| Classification Name: | 21 CFR 888.3660, shoulder joint metal/polymer semi-constrained<br>cemented prosthesis |
| Regulatory Class: | Class II |
| Product Code: | KWS |

#### III. Predicate Device

Aequalis PerFORM+ Shoulder System, K150583

#### IV. Device Description

The Aequalis PerFORM+ Shoulder System is a modular system consisting of a metaphyseal humeral stem component, anatomic humeral heads and glenoid for a total shoulder athroplasty. Surgical instruments are designed to facilitate proper implantation of the system.

#### V. Intended Use

The Tornier shoulder prostheses are intended for replacement of the shoulder joint to reduce pain and improve shoulder mobility in comparison with preoperative status.

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#### Indications For Use VI.

Prosthetic replacement with this device (Aequalis PerFORM+ glenoid component and humeral component) may be indicated to relieve severe pain or significant disability caused by:

- . Degenerative pathologies: arthrosis, rheumatoid arthritis, post-traumatic arthrosis.
- Primary or secondary necrosis of the humeral head. ●
- Displaced 4-part upper humeral fracture ●
- . Humeral head fracture
- Other pathologies where arthrodesis or resectional arthroplasty of the humeral head ● are not acceptable.
- Revision surgery when other treatments or devices have failed. .

The Aequalis PerFORM+ glenoids are intended for cemented use only.

The Aequalis monbloc stem is for cemented use

The Aequalis press-fit is for uncemented use

#### VII. Comparison of Technological Characteristics with the Predicate Device

The Aequalis PerFORM+ Shoulder System has the same intended use and fundamental scientific technology as the predicate device. The design differences do not affect safety or effectiveness or raise new issues of safety or effectiveness.

#### Non-Clinical Performance Data VIII.

The following performance data were provided in support of the substantial equivalence determination.

| Validation and / or<br>Verification Method | Acceptance Value / Criteria | Results |
|--------------------------------------------|----------------------------------------------|------------|
| Loosening Test | No Loosening detected at completion of test. | Acceptable |
| Shear testing | Comparable to the predicate device design. | Acceptable |
| Tensile (pull out) testing | Comparable to the predicate device design. | Acceptable |
| Endotoxin | $ ≤ 20 EU / device $ | Acceptable |

# Performance Data

#### IX. Clinical Study

Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.

#### X. Conclusions

The Aequalis PerFORM+ Shoulder System described in this section has the same intended use and the same fundamental scientific technology as the cleared Aequalis Shoulder System. Based on the testing presented for the design differences between the subject and predicate devices, Tornier concludes that subject device is substantially equivalent to the predicate device.