BIO-MODULAR SHOULDER SYSTEM

K030710 · Biomet, Inc. · KWT · Jun 4, 2003 · Orthopedic

Device Facts

• Record ID: K030710
• Device Name: BIO-MODULAR SHOULDER SYSTEM
• Applicant: Biomet, Inc.
• Product Code: KWT · Orthopedic
• Decision Date: Jun 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3650
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The components of Bio-Modular® Shoulder System included in this submission are intended for total shoulder joint arthroplasty. Indications for use include: 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 2) Rheumatoid arthritis 3) Revision where other devices or treatments have failed 4) Correction of functional deformity 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

Device Story

Bio-Modular Shoulder System is a modular total shoulder replacement prosthesis. Components include humeral stem, modular humeral head, and glenoid component (metal-backed or all-polyethylene). Humeral stem features biplaner taper for stress transfer, lateral fin for rotational stability, and collar to minimize subsidence. Proximal stems are circumferentially porous coated for biological fixation. Reverse Morse taper allows attachment of modular, offset, or bi-polar humeral heads. Metal-backed glenoid components use central peg and optional screws for fixation; all-polyethylene components are for cemented use. Device is implanted by orthopedic surgeons in a clinical/OR setting to replace the shoulder joint, restore function, and alleviate pain from degenerative disease, arthritis, or fractures.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing demonstrating mechanical performance under expected clinical conditions and characterization of the porous surface.

Technological Characteristics

Modular shoulder prosthesis consisting of humeral stem, modular heads, and glenoid components. Materials include metal and polymer. Features include reverse Morse taper, biplaner taper, lateral fin, and circumferential porous coating for biological fixation. Cemented or uncemented application depending on component type. No software or electronic components.

Indications for Use

Indicated for patients requiring total shoulder joint arthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, revision of failed prior treatments, functional deformity, proximal humerus fractures, or complex conditions like cuff arthropathy.

Regulatory Classification

Identification

A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,” (vii) F 1378-97 “Specification for Shoulder Prosthesis,” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Bio-Modular® Shoulder System (K872454, K915596, K992119, K992899, K002998)
• Global® Advantage Shoulder System (K914695, K943300, K974044, K981487, K011047)

Submission Summary (Full Text)

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K030710

p. 1/2

JUN - 4 2003

Image /page/0/Picture/3 description: The image shows the logo for Biomet Orthopedics, Inc. The word "BIOMET" is in a bold, sans-serif font, with the letters connected. Below the word "BIOMET" is the phrase "ORTHOPEDICS, INC." in a smaller, serif font.

## Summary of Safety and Effectiveness

| Applicant or Sponsor: | Biomet Orthopedics, Inc.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0588 |
|-----------------------|---------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Sandborn Beres<br>Senior Regulatory Specialist<br>Phone: [phone]<br>FAX: [phone] |

Trade Name: Bio-Modular® Shoulder System

Common Name: Total shoulder replacement components

#### Classification Name:

- 1. Prosthesis, Shoulder, Non-constrained, Metal/Polymer, Cemented (21 CFR Section 888.3650)
- 2. Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Cemented (21 CFR Section 888.3660)
- 3. Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Uncemented (21 CFR Section 888,3670)
- 4. Prosthesis, Shoulder, Homi-, Humeral, Metallic, Cemented or Uncemented (21 CFR Section 888.3690)

## Legally Marketed Device to which Substantial Equivalence is claimed:

- The Bio-Modular® Shoulder System cleared by 510(k)s K872454, K915596, ● K992119, K992899 and K002998.
- The Gobal® Advantage Shoulder System cleared by 510(k)s K914695, ● K943300, K974044, K981487 and K011047.

Device Description: The Bio-Modular® Shoulder System consists of a humeral stem that is used in conjunction with a modular head and a metal backed or all polyethylene glenoid component. The Humeral Component is available in various lengths and porous coating levels. The Bio-Modular® Humeral stern features a biplaner taper to promote stress transfer down the length of the stem. Each stem has a lateral fin to provide rotational stability. Holes in the fin provide the surgeon with the option of suture attachment during fracture reconstruction. A collar minimizes subsidence. The stems are circumferentially porous coated proximally to provide fixation by tissue ingrowth.

| MAILING ADDRESS | P.O. Box 587<br>Warsaw, IN 46581-0587 |
|-----------------|---------------------------------------|
|-----------------|---------------------------------------|

| SHIPPING ADDRESS | Airport Industrial Park<br>Warsaw, IN 46580 |
|------------------|---------------------------------------------|
|------------------|---------------------------------------------|

| OFFICE | 219.267.6639 |
|--------|-------------------|
| FAX | 219.267.8137 |
| E-MAIL | [e-mail] |

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The proximal portions of the humeral stems feature a reverse Morse taper for attachment of the modular humeral head. Offset and Bi-Polar humeral heads are also available.

Modular, metal backed glenoid components are available for total shoulder replacement. These devices feature a central peg and the option of using screws for immediate fixation and porous coating to provide biological fixation when used without bone cement. All polyethylene glenoid components are available for cemented application.

Intended Use: The components of Bio-Modular® Shoulder System included in this submission are intended for total shoulder joint arthroplasty. Indications for use include:

- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 3) Revision where other devices or treatments have failed
- 4) Correction of functional deformity
- 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
- 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

Summary of Technologles: The materials, surface finishes and processing of the Bio-Modular® Shoulder System are similar to the predicate device.

Non-Clinical Testing: Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions. A full characterization of the porous surface has been provided.

Clinical Testing: None provided.

All trademarks are property of Biomet, Inc. except for the following: Gobal is a trademark of DePuv. Inc.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 4 2003

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Orthopedics, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K030710

Trade/Device Name: Bio-Modular® Shoulder System Regulation Number: 21 CFR 888.3650, 888.3660, 888.3670, 888.3690 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis; Shoulder joint metal/polymer semi-constrained cemented prosthesis; Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis; and Shoulder joint humeral (hemishoulder) metallic uncemented prosthesis Regulatory Class: II

Product Code: KWT, KWS, MBF, and HSD Dated: March 4, 2003 Received: March 6, 2003

Dear Ms. Beres:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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

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## Page 2 - Ms. Patricia Sandborn Beres

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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Merle A. Millican

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

#### Device Name: Bio-Modular® Shoulder System

#### Indications For Use:

- 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- 2) Rheumatoid arthritis
- 3) Revision where other devices or treatments have failed
- 4) Correction of functional deformity
- 5) Fractures of the proximal humerus, where other methods of treatment are deemed inadequate
- 6) Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate

Devices with surface coatings are indicated for cemented or uncemented biological fixation application. Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Division of General, Restorative

510(k) Number