ASCEND SHOULDER SYSTEM

K120794 · Tornier, Inc. · KWS · Apr 13, 2012 · Orthopedic

Device Facts

• Record ID: K120794
• Device Name: ASCEND SHOULDER SYSTEM
• Applicant: Tornier, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Apr 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascend Shoulder System consists of a humeral stem (offered in two versions: Titanium Plasma Spray coated and un-coated version), a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled by: Rheumatoid arthritis with pain . Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) . Correction of functional deformity . Fractures of the humeral head . Traumatic arthritis . Revision of other devices if sufficient bone stock remains . All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

Device Story

Shoulder prosthesis system comprising humeral stem (titanium plasma spray coated or uncoated), humeral head, and optional polyethylene glenoid; used for hemiarthroplasty or total shoulder replacement. Intended for patients with intact/reconstructable rotator cuff to restore mobility/stability and relieve pain. Implanted by orthopedic surgeons in clinical settings. Humeral stem designed for cementless fixation; glenoid for cemented fixation. System provides mechanical replacement of diseased/damaged shoulder joint components.

Clinical Evidence

Bench testing only; includes coating validation, stem strength testing, and cadaveric evaluation.

Technological Characteristics

Materials: Titanium plasma spray (Ti PS) coated or uncoated humeral stem, polyethylene glenoid. Design: Modular shoulder prosthesis (humeral stem, head, glenoid). Fixation: Cementless (stem), cemented (glenoid). Single-use components.

Indications for Use

Indicated for patients with intact or reconstructable rotator cuff requiring shoulder joint replacement due to rheumatoid arthritis, non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), functional deformity, humeral head fractures, traumatic arthritis, or revision of prior devices with sufficient bone stock.

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

• Tornier Ascend Shoulder System (K113413)
• Biomet Comprehensive Shoulder System (K060692)

Submission Summary (Full Text)

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# APR 1 3 2012

# SECTION 5: SPECIAL 510(K) PREMARKET NOTIFICATION

## Summary of Safety and Effectiveness information

## Tornier Inc. Ascend Shoulder System

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

#### 1) Device name

| Trade name: | Ascend Shoulder System |
|--------------|------------------------|
| Common name: | Shoulder Prosthesis |

#### Classification Number/ Classification name/Product code:

- · Shoulder joint metal/polymer non-constrained cemented prosthesis are class II devices under 21 CFR 888.3650 (product code KWT) and are classified by the Orthopedic Devices Panel
- · Shoulder joint metal/polymer semi-constrained cemented prosthesis are class II devices under 21 CFR 888.3660 (product code KWS) and are classified by the Orthopedic Devices Panel
- · Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis are class II devices under CFR 888.3690 (product code HSD) and are classified by the Orthopedic Devices Panel

### 2) Submitter

Tornier Inc. 7701 France Avenue South; Suite 600 Edina, MN 55435 Registration Number: 9100540

#### 3) Company contact

Brahim Hadri Sr. Regulatory affairs Specialist 7701 France Avenue South, Suite 600 Edina. MN 55435 USA Telephone: [phone] Fax: [phone] Email: [e-mail]

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#### 4) Classification

Device class: Classification panel: Product code:

Class II Orthopedic KWT; KWS; HSD;

#### 5) Legally Marketed Device to which Equivalence is Claimed:

- Primary Predicate: Tornier Ascend Shoulder System: K113413 .
- Secondary Predicate: Biomet Comprehensive Shoulder System: K060692 .

#### 6) Device description

The Ascend Shoulder System consists of a humeral stem Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.

### The present device submission corresponds to changes made to the version of the device cleared in 510(k) K113413.

#### 7) Indications for Use

The Ascend Shoulder System consists of a humeral stem (offered in two versions: Titanium Plasma Spray coated and un-coated version), a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled bv:

- Rheumatoid arthritis with pain .
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
- Correction of functional deformity ●
- Fractures of the humeral head .
- Traumatic arthritis .
- Revision of other devices if sufficient bone stock remains .

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

#### 8) Summary of technologies

The modified Ascend Shoulder System was subjected to non-clinical testing such as coating validation; stem strength and cadaveric evaluation. The results of these non-clinical tests allow us to conclude that the Ascend Shoulder System described in this submission is substantially equivalent and as safe and effective as the original device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Tornier, Incorporated % Mr. Brahim Hadri Senior Regulatory Affairs Specialist 7701 France Avenue South, Suite 600 Edina, Minnesota 55435

APR 1 3 2012

Re: K120794

Trade/Device Name: Ascend™ Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD Dated: March 15, 2012 Received: March 15, 2012

Dear Mr. Hadri:

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 or car) i vith 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 Or FF art 607), as the (21 CFR 803); good manufacturing practice requirements as set

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### Page 2 - Mr. Brahim Hadri

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Emil Keith

J-Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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K120794

## INDICATIONS FOR USE

## 510(k) Number (if known):

Ascend™ Shoulder System Device Name:

#### Indications for Use

The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain.

The Ascend Shoulder System is indicated for use as a replacement of shoulder joints disable by:

- Rheumatoid arthritis with pain .
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
- Correction of functional deformity .
- Fractures of the humeral head .
- Traumatic arthritis ●
- Revision of other devices if sufficient bone stock remains ●

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

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

AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120774

Special 510(k) Submission: Tornier Inc. Ascend Shoulder System