ASCEND SHOULDER SYSTEM

K113413 · Tornier, Inc. · KWS · Mar 9, 2012 · Orthopedic

Device Facts

• Record ID: K113413
• Device Name: ASCEND SHOULDER SYSTEM
• Applicant: Tornier, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Mar 9, 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, 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 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

Ascend Shoulder System is a modular orthopedic prosthesis comprising a humeral stem, mating humeral head, and optional all-polyethylene glenoid. Used for hemiarthroplasty or total shoulder replacement. Implanted by orthopedic surgeons in clinical/surgical settings to replace joints disabled by arthritis, trauma, or deformity. Provides increased mobility and pain relief. Humeral stem designed for cementless fixation; glenoid component for cemented fixation. All components are single-use. Device functions as a mechanical bearing surface to restore joint function.

Clinical Evidence

No clinical data. Evidence consists of bench testing (taper disassembly strength, mismatch evaluation, extraction testing) and cadaveric evaluation.

Technological Characteristics

Modular shoulder prosthesis. Materials: metal (humeral components) and polyethylene (glenoid). Humeral stem: cementless. Glenoid: cemented. Single-use. Mechanical bearing interface.

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

• Nexa Orthopedics Total Shoulder System (K071147)

Submission Summary (Full Text)

{0}------------------------------------------------

# 亿113413

### 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

Ascend Shoulder System Trade name: Shoulder Prosthesis Common name:

#### 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]

Page 11 of 75

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

Page 1 of 2

{1}------------------------------------------------

## KII 3413

| <b>4) Classification</b> | |
|--------------------------|----------------|
| Device class: | Class II |
| Classification panel: | Orthopedic |
| Product code: | KWT; KWS; HSD; |

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

- . Tornier (Nexa Orthopedics Total Shoulder System) Ascend Shoulder System: K071147
#### 6) Device description

The Ascend Shoulder System consists of a humeral stem, 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 svstem.

The present device submission corresponds to changes made to the version of the device cleared in 510(k) K071147.

#### 7) Indications for Use

The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polvethylene 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 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.

#### 8) Summary of technologies

The modified Ascend Shoulder System was subjected to non-clinical testing such as taper disassembly strength; mismatch evaluation; extraction testing 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.

Page 12 of 75

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

Page 2 of 2

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

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

MAR - 9 2012

Tornier Inc. % Mr. Brahim Hadri 7701 France Ave South Suite 600 Edina, Minnesota 55435

Re: K113413

Trade/Device Name: Ascend 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, KWT, HSD Dated: February 7, 2012 Received: February 8, 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 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

{3}------------------------------------------------

Page 2 – Mr. Brahim Hadri

I ago 2 - 14: Drama and (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 Jou doo!!! spee.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,

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

Enclosure

{4}------------------------------------------------

# ા 3-13

### 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 The Ascend Shounder Dystem vonelible on may be used by themselves, as a hemiarthroplasty, if the natural glenoid. The stem and nead insy of ace, or in conjunction with the glenoid, as a total natural gionold provides a Summers System is to be used only in patients with an intact or replacement. The risoend choulder 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 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 _ (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)

D.O.M.

(Division Sign-Off) Division Sign of Surgical, Orthopedic, and Restorative Devices

510(k) Number 上

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

Page 10 of 97