ANATOMICA HUMERAL STEM/HEAD COMPONENTS

K990137 · Sulzer Orthopedics, Inc. · KWS · Feb 18, 1999 · Orthopedic

Device Facts

• Record ID: K990137
• Device Name: ANATOMICA HUMERAL STEM/HEAD COMPONENTS
• Applicant: Sulzer Orthopedics, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Feb 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Anatomica Humeral Stem/Head is intended for cemented use in treatment of the following: 1. Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis. 2. Omarthrosis. 3. Rheumatoid arthritis. 4. Revision of shoulder prosthesis. 5. Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

Device Story

Anatomica Humeral Stem/Head is a cemented shoulder prosthesis for proximal humerus replacement. System comprises forged stainless steel (ISO 5832-9) humeral stem and cast CoCrMo alloy (ISO 5832-4) humeral heads. Stem features trumpet-shaped proximal aspect for metaphyseal fit, lateral fin for rotational stability, and suture/wire holes for tuberosity attachment. Slit-ball head mechanism allows variable angle fixation via impact screw and expansion cone; traumatology cone available for fracture cases. Heads available in multiple sizes/heights with eccentric female recess. Device implanted by orthopedic surgeons in clinical/OR settings. Provides joint articulation to restore function and reduce pain in arthritic or traumatized shoulders.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing performed to verify device survival under physiologic loading conditions. No clinical data provided.

Technological Characteristics

Materials: Forged stainless steel alloy (ISO 5832-9) for stem; cast CoCrMo alloy (ISO 5832-4) for heads. Design: Cemented, semi-constrained prosthesis. Features: Slit-ball head fixation mechanism with expansion/traumatology cones for variable angle positioning. Stem sizes: 4. Head sizes: 40-52mm diameter. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring shoulder joint replacement due to degenerative, posttraumatic, or rheumatoid arthritis, omarthrosis, or revision of shoulder prosthesis. Includes traumatology applications using specific traumatology cone.

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

• Sulzer Orthopedics Select Shoulder Titanium Humeral Prosthesis
• Sulzer Orthopedics Select Shoulder CoCr Humeral Stem Prosthesis
• Orthomet/3M Modular Neer II Shoulder System
• Zimmer Fenlin Total Shoulder
• Smith & Nephew Richards Cofield Shoulder
• Kirschner/Biomet Atlas Shoulder
• Kirschner/Biomet Mod II-C Shoulder
• Biomet Bio-Modular Total Shoulder
• Depuv Global Total Shoulder System

Submission Summary (Full Text)

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2/18/99

K990137

## 510(k) SUMMARY

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Anatomica Humeral Stem/Heads.

| Manufacturer: | Sulzer Orthopedics Ltd.<br>Grabenstrasse 25<br>CH 6341 Baar, Switzerland |
|-------------------------|-----------------------------------------------------------------------------------------|
| US Designated Agent: | Sulzer Orthopedics Inc.<br>9900 Spectrum Drive<br>Austin, Texas 78717<br>[phone] |
| Date: | January 15, 1998 |
| Contact Person: | Mitchell A. Dhority, RAC<br>Manager, Regulatory Affairs |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented<br>prosthesis - 21 CFR 888.3660 |
| Common/Usual Name: | Humeral Stem and Head Components |
| Trade/Proprietary Name: | Sulzer Orthopedics Anatomica Humeral Stem/Head |

### PRODUCT DESCRIPTION

#### Humeral Stem

The Anatomica Humeral Stem Component is intended for replacement of the proximal portion of the humerus.

The Anatomica Humeral Stem is a metallic humeral component manufactured from forged stainless steel alloy (ISO 5832-9). It is available in four sizes which are determined by the diameter of the stem. The proximal aspect of the stem is "trumpet shaped" to match the metaphysis of the humeral shaft. Rotational stability is ensured by a proximal fin on the lateral Two holes in the fin and one in the medial stem body allow for attachment of the aspect. tuberosities via sutures/wires.

The stem features a slit-ball head fixed at an angle of 135°. An impact screw and expansion cone are inserted through a shaft in the lateral aspect of the stern and into the slit-ball head at the time of surgery. This forces the slit-ball feature to spread open allowing fixation of one of the humeral heads used with the system. The use of the slit ball has the advantage of allowing fixation of the head in a variety of angles. A traumatology cone identical to the expansion cone, except with positioning pegs for head placement, is also available.

#### Humeral Heads

The heads are manufactured from cast CoCrMo alloy (ISO 5832-4). They are available in 10

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sizes with diameters ranging from 40-52mm (in 2mm increments). Sizes 48, 50 and 52mm are offered in two head heights. The spherical female recess for attachment to the slit-ball head of the stem is situated eccentrically to the radius of the humeral head. This recess also features two internal holes for defining position in fracture cases (used in conjunction with the traumatology cone).

#### SPECIFIC DIAGNOSTIC INDICATIONS

The Anatomica Humeral Stem/Head is intended for cemented use in treatment of the following:

- 1. Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- 2. Omarthrosis.
- 3. Rheumatoid arthritis.
- Revision of shoulder prosthesis. 4.
- 5. Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

#### SUBSTANTIAL EQUIVALENCE

The Anatomica Humeral Prosthesis is similar to the Sulzer Orthopedics Select Shoulder Titanium Humeral Prosthesis, the Sulzer Orthopedics Select Shoulder CoCr Humeral Stem Prosthesis, the Orthomet/3M Modular Neer II Shoulder System, the Zimmer Fenlin Total Shoulder, the Smith & Nephew Richards Cofield Shoulder, the Kirschner/Biomet Atlas Shoulder, the Kirschner/Biomet Mod II-C Shoulder, the Biomet Bio-Modular Total Shoulder, and the Depuv Global Total Shoulder System.

Static and Dynamic Testing indicated that the device would survive physiologic loading.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles that are connected to each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1999

Mr. Mitchell A. Dhority Manager, Regulatory and Clinical Affairs Sulzer Orthopedics Inc. 9900 Spectrum Drive Austin, Texas 78717

K990137 Re: Anatomica Humeral Stem/Head Components Trade Name: Regulatory Class: III KMS Product Code: January 12, 1999 Dated: Received: January 14, 1999

Dear Mr. Dhority:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 1 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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#### Page 2 - Mr. Mitchell A. Dhority

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) Number (if known): | K990137 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Anatomica Humeral Stem/Heads

# Indications for Use:

The Anatomica Humeral Stem/Head is intended for cemented use in treatment of the following:

and the control of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contrib

- Advanced wear and tear of the shoulder joint resulting from degenerative, 1. posttraumatic or rheumatoid arthritis.
- Omarthrosis. 2.
- 3. Rheumatoid arthritis.
- Revision of shoulder prosthesis. 4.
- Traumatology: the only cone to be used in traumatological indications is the 5. traumatology cone.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K990137 |

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