ASCENSION MODULAR TOTAL SHOULDER SYSTEM

K100448 · Ascension Orthopedics, Inc. · KWS · Aug 30, 2010 · Orthopedic

Device Facts

• Record ID: K100448
• Device Name: ASCENSION MODULAR TOTAL SHOULDER SYSTEM
• Applicant: Ascension Orthopedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Aug 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement 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 indicates 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). Shoulder Hemiarthroplasty is also indicated for: 1. Ununited humeral head fractures. 2. Avascular necrosis of the humeral head. 3. Rotator cuff arthropathy. 4. Deformity and/or limited motion. The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.

Device Story

Modular shoulder prosthesis system; includes proximal bodies, humeral stems, humeral heads, and all-polyethylene glenoid components. Components connect via Morse-type taper. Humeral heads (CoCrMo alloy) available in concentric/eccentric configurations; glenoid components (UHMWPE) available in keeled/pegged designs. Used by orthopedic surgeons in clinical settings for joint replacement. Provides mechanical bearing surface to replace damaged articular surfaces; restores joint function; reduces pain. Humeral component supports cemented or uncemented fixation; glenoid component requires cement.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included axial disassembly force of taper connections, bending taper fatigue endurance, and dynamic evaluation of glenoid loosening.

Technological Characteristics

Modular shoulder prosthesis. Materials: Cobalt-chrome-molybdenum (CoCrMo) alloy for humeral heads; Ultra-high molecular weight polyethylene (UHMWPE) for glenoid components. Connection: Morse-type taper. Fixation: Humeral component (cemented/uncemented); Glenoid component (cemented).

Indications for Use

Indicated for patients with severely painful/disabled shoulder joints due to osteoarthritis, traumatic/rheumatoid arthritis, proximal humerus fracture-dislocations, ununited humeral head fractures, avascular necrosis, rotator cuff arthropathy, or deformity/limited motion requiring hemi or total shoulder replacement.

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

• Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System (K032126/K063578)
• Osteonics' All Polyethylene Glenoid Shoulder Keeled Components (K962082)

Submission Summary (Full Text)

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K100448

510(k) Summary

| SUBMITTER NAME: | Ascension Orthopedics, Inc.<br>8700 Cameron Road<br>Austin, TX 78754-3832 | AUG 30 2010 |
|-----------------|------------------------------------------------------------------------------------------|-------------|
| 510(k) CONTACT: | Stanley J. Harris<br>Phone: [phone] x1545 | |
| DATE: | August 26, 2010 | |
| TRADE NAME: | Ascension® Modular Total Shoulder System | |
| COMMON NAME: | Hemi- or Total shoulder | |
| CLASSIFICATION: | 21 CFR 888.3690 Shoulder joint humeral (hemi-shoulder)<br>metallic uncemented prosthesis | |
| | 21 CFR 888.3660, Shoulder joint metal/polymer semi-<br>constrained cemented prosthesis | |
| PRODUCT CODE: | HSD and KWS | |
| PANEL: | Orthopedic | |

#### PREDICATE DEVICES:

K032126/K063578 - Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System

K962082: Osteonics' All Polyethylene Glenoid Shoulder Keeled Components

# DEVICE DESCRIPTION:

The Modular Total Shoulder System consists of a line of proximal bodies, humeral stems, humeral heads and all polyethylene glenoid components. The body, stem and humeral head may be used by themselves, as a hemiarthroplasty, if the natural numeral nead may befficient bearing surface, or in conjunction with the glenoid, as a gronold proximal bodies and humeral stems are manufactured from total replacemont: "The and connect together via a Morse type taper. The humeral theads are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and are offered in both concentric and eccentric configurations. The humeral head may onered in both contral glenoid bone if it is of sufficient quality, or against the all antionate against the naturanid. The glenoid is manufactured from ultra high polycthylone oomonton gronone (UHMVPE) and is offered in a keeled and pegged molecular weight porychylons (Ornaare designed to function with both the concentric and eccentric heads.

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# INTENDED USE:

The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement 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 indicates 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).

Shoulder Hemiarthroplasty is also indicated for:

- 1. Ununited humeral head fractures.
- 2. Avascular necrosis of the humeral head.
- 3. Rotator cuff arthropathy.
- 4. Deformity and/or limited motion.

The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.

### SUMMARY OF TECHNOLOGIES:

There are no significant differences between the Ascension® Modular Total Shoulder System, to the Smith & Nephew/Plus Orthopedics PROMOS Modular Shoulder System (K032126/K063578) currently being marketed which would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and intended use.

#### SUBSTANTIAL EQUIVALENCE:

Substantial equivalence was based upon testing and a geometrical comparison of the subject and predicate devices. Tests performed to substantiate equivalence were: axial disassembly force of taper connections, bending taper fatigue endurance, and dynamic evaluation of glenoid loosening. Geometrical comparisons were between the subject device, Ascension TITAN Modular Total Shoulder System and predicate devices: Smith & Nephew/PLUS PROMOS Modular Shoulder System (K032126, uons578) and the Osteonics' All Polyethylene Glenoid Shoulder Keeled Components (K962082).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a stylized serpent winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the caduceus.

Public Health Service

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

Ascension Orthopedics, Inc. % Mr. Stanley J. Harris Vice President, Clinical/Regulatory Affairs 8700 Cameron Road, Suite 100 Austin, Texas 78754

AUG 30 2010

Re: K100448

Trade/Device Name: Ascencion® Modular Total Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS. HSD Dated: August 10, 2010 Received: August 17, 2010

Dear Mr. Harris:

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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Mr. Stanley J. Harris

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.

Sincerely vours.

Sincerely yours,

Carbare Buere

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 Statement

K100448 510(k) Number.

Ascension® Modular Total Shoulder System Device Name:

## Indications for Use:

The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement 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 indicates 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).
Shoulder Hemiarthroplasty is also indicated for:

- 1. Ununited humeral head fractures.
- 2. Avascular necrosis of the humeral head.
- 3. Rotator cuff arthropathy.
- 4. Deformity and/or limited motion.

The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.

Prescription Use x (Part 21 CFR 801Subpart B)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Knutar der Mom

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

510(k) Number KJ 00448

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