AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM

K110865 · Tornier, Inc. · KWS · Apr 27, 2011 · Orthopedic

Device Facts

• Record ID: K110865
• Device Name: AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
• Applicant: Tornier, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Apr 27, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Aequalis Ascend Modular Anatomic 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

Device Story

Modular shoulder prosthesis system; components include distal stem, anatomic metaphysis, and assembly screw. Assembled in OR by surgeon; mates with existing humeral heads and glenoid replacements. Distal stem and metaphysis made of Ti-6Al-4V ELI; assembly screw made of CoCrMo alloy with UHMWPE plug to prevent loosening. Single-use components; humeral stem for cemented or cementless use; glenoid component for cemented use. Provides structural replacement for diseased or damaged shoulder joints; restores function and reduces pain.

Clinical Evidence

Bench testing only.

Technological Characteristics

Modular shoulder prosthesis. Materials: Ti-6Al-4V ELI (ASTM F136) for stem/metaphysis; CoCrMo alloy (ASTM F1537) for assembly screw; UHMWPE (ASTM F648/ISO 5834-2) plug. Single-use. Cemented or cementless humeral stem; cemented glenoid component.

Indications for Use

Indicated for patients with shoulder joint disability due to rheumatoid arthritis, non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), functional deformity, humeral head fractures, or traumatic arthritis.

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 Inc. Aequalis Ascend Modular Anatomic Shoulder System (K102924)

Reference Devices

• Tornier Ascend Monolithic Humeral Heads (K071147)
• Tornier Aequalis Glenoid replacements (K063081)
• Tornier Affiniti Glenoid replacements (K060988)

Submission Summary (Full Text)

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K110865

# SECTION 5

# 510(k) SUMMARY Summary of Safety and Effectiveness information

# Tornier Inc. Aequalis Ascend Modular Anatomic Shoulder System

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

- 1) Device name
Aequalis Ascend Modular Anatomic Shoulder System Trade name: Shoulder Prosthesis Common name: Classification Number/ Classification name/Product code:

- . Shoulder joint, humeral (hemi-Shoulder), metallic uncemented prosthesis are class II devices under 21 CFR 888.3690 (product code HSD) and are classified by the Orthopedic Devices Panel
- 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

## 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 100 Cummings Center, Suite 444C, Beverly, MA 01915, U.S.A Phone: [phone] ext: 617 1 978-232-9998 Fax: [e-mail]

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

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- 4) Classification Device class: Classification panel: Product code:
Class II Orthopedic HSD; KWT; KWS

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

· Tornier Inc. Aequalis Ascend Modular Anatomic Shoulder System K102924

# 6) Device description

The Aequalis Ascend Modular Anatomic Shoulder system is supplied in separate sterile packages which will be assembled in the operating room. The system is comprised of the following components:

- The Modular Distal Stem ●
- The Modular Anatomic Metaphysis .
- The Modular Anatomic Assembly Screw. .

This assembly will mate with existing; FDA cleared Tornier Ascend Monolithic Humeral Heads (K071147) which were designed to articulate with FDA cleared Tornier Aequalis and Affiniti Glenoid replacements (K063081 and K060988 respectively).

This submission corresponds to a change made to the Aequalis Ascend Modular Anatomic Shoulder System (previously cleared in 510(k) K102924).

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### 7) Materials

- The Modular Distal Stem and Modular Anatomic Metaphysis components are manufactured . from Titanium according to ASTM F 136 Standard Specification for Wrought Titanium -6Aluminum - 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
- The Modular Anatomic Assembly Screw is manufactured from Cobalt Chromium Molybdenum . alloy according to ASTM F-1537 Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants
- The Modular Anatomic Assembly Screw includes an Ultra High Molecular Weight . Polyethylene (UHMWPE) plug to prevent loosening. The material of the screw is accordance to ASTM F648 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants or ISO-5834-2. Implants for surgery -- Ultra-high-molecular-weight polyethylene -- Part 2: Moulded forms

#### 8) Indications for Use

- The Aequalis Ascend Modular Anatomic Shoulder System is indicated for use . as a replacement of Shoulder joints disabled by:
- Rheumatoid arthritis with pain O

KII 0865

- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and O avascular necrosis)
- Correction of functional deformity O
- Fractures of the humeral head 0
- Traumatic arthritis ্

#### Notes:

- All components are single use .
- The humeral stem is intended for cemented or cementless use .
- The glenoid component is intended for cemented use o

#### 9) Summary of technologies

The modifications made to the proposed Tornier Aequalis Ascend Modular Anatomic Shoulder System were verified and validated by performing bench testing. The results of the testing allow us to conclude that the proposed Aequalis Ascend Modular Anatomic Shoulder System described in this submission does not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

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

Tornier, Inc. % Mr. Brahim Hadri Senior Regulatory Affairs Specialist 100 Cummings Center. Suite 444C Beverly, Massachusetts 01915

APR 2 7 2011

Re: K110865

Trade/Device Name: Aequalis® Ascend™ Modular Anatomic 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: March 25, 2011 Received: March 29, 2011

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, Trug, 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,

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## Page 2 - Mr. Brahim Hadri

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 device-related adverse events) (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 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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely vours.

Ak-y B. Rin h

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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# Indications for Use

510(k) Number (if known): ذَهال؟ || OSS || OS

#### Aequalis® Ascend™ Modular Anatomic Shoulder System Device Name:

#### Indications for Use

- . The Aequalis Ascend Modular Anatomic Shoulder System is indicated for use as a replacement of Shoulder joints disabled by:
- Rheumatoid arthritis with pain 0
- Non-inflammatory degenerative joint disease (i.e. osteoarthritis and 0 avascular necrosis)
- Correction of functional deformity 0
- Fractures of the humeral head 0
- Traumatic arthritis O

## Notes:

- All components are single use ●
- The humeral stem is intended for cemented or cementless use
- The glenoid component is intended for cemented use .

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)

for M. Malkerson

(Division Sign-Off) (Division Sign-gical. Orthopedic, Divisionative Devices

510(k) Number K110865

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Special 510(k) Submission:

Tornier Inc. Aequalis Ascend Modular Anatomic Shoulder System

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