VERSA-DIAL HUMERAL HEAD

K040610 · Biomet Manufacturing, Inc. · KWS · Jun 4, 2004 · Orthopedic

Device Facts

• Record ID: K040610
• Device Name: VERSA-DIAL HUMERAL HEAD
• Applicant: Biomet Manufacturing, Inc.
• Product Code: KWS · Orthopedic
• Decision Date: Jun 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 tear arthropathy, where other methods of treatment may not be suitable or may be inadequate. The Versa-Dial™ Humeral Head Prosthesis is intended for use with the Comprehensive Humeral Fracture System, either cemented or uncemented (press-fit) use. The Versa-Dial™ Humeral Head Prosthesis is intended for use with the glenoid components of the Bio-Modular® Shoulder System, either all polyethylene for cemented use or porous coated for biological fixation (with optional screw fixation) use.

Device Story

Versa-Dial™ Humeral Head Prosthesis; metallic articulating surface component for shoulder arthroplasty. Used in conjunction with Comprehensive Humeral Fracture System or Bio-Modular® Shoulder System. Implanted by orthopedic surgeons in clinical/surgical settings. Functions as humeral head replacement; supports cemented or uncemented (press-fit) fixation. Provides structural articulation for shoulder joint; restores joint function; addresses degenerative disease, fractures, and revision cases. Benefits patient through pain relief and improved joint mobility.

Clinical Evidence

Bench testing only; no clinical data required.

Technological Characteristics

Material: Co-Cr-Mo alloy (ASTM F 75). Form factor: Humeral head prosthesis. Fixation: Cemented or uncemented (press-fit).

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, proximal humerus fractures, or complex clinical management issues (e.g., cuff tear arthropathy) where other treatments are inadequate or failed.

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

• Comprehensive Humeral Fracture System (K023063)
• Bio-Modular® Shoulder System (K030710)

Submission Summary (Full Text)

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K040610

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BIOMET

JUN 0 4 2004

#### 510(k) Summary

| Applicant/Sponsor: | Biomet Manufacturing Corp. | |
|--------------------|-------------------------------------|--|
| Contact Person: | Gary Baker<br>Regulatory Specialist | |
| Proprietary Name: | Versa-Dial™ Humeral Head Prosthesis | |
| Common Name: | Shoulder Prosthesis | |

#### Classification Name:

Classification Name.
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented (21 CFR 5888 3650). Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Cemented (21 CFR §888.3660). Frosthesis, Shoulder, Semi-Colliance, Non-Constrained or Semi-Constrained, Porous Coated, Uncemented Prosthesis (21 CFR §888.3670). Oncemented Frosmess (21 CFR 300013070).
Shoulder Joint, Humeral, (Hemi-Shoulder), Metallic, Uncemented Prosthesis (21 CFR §888.3690).

# Legally Marketed Devices To Whicb Substantial Equivalence Is Claimed:

- 1. Comprehensive Humeral Fracture System Biomet Inc. (K023063)
- 2. Bio-Modular® Shoulder System (K030710)

Device Description: The Versa-Dial™ Humeral Head Prosthesis is a metallic humeral head Device Description as the articulating surface component of the Comprehensive Humeral Fracture designed to lunchon as the arrounting oncess coted were and incorporates the glemoid Stein (R02005) for elater ochier System (K030710) that are either all polyethylene for component of the Dio-Modular "bhounder by chias (cical fixation with optional screw fixation) use. centioned use of them basited 107 assesser are manufactured of Co-Cr-Mo alloy conforming to ASTM F 75.

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

72

MAILING ADDRESS 12.0. 130x 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 F. Bell Drive Warsaw, IN 46582

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OFFICE 574.267.6639

FAX [phone]

E-MAIL וחסב שגרגת ולוח המחלול והרגולות ווי

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- 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, Difficult onlined meather the may not be suitable or may be inadequate.

Summary of Technologies: The Versa-Dial™ Humeral Head Prosthesis is similar to or dentical in Summary of Technologics. The Versa Dial - He predicate Bio-Modular® Shoulder System
terms of material, function, labeling, and sizing to the predicate Bio-Modular (K030710), and the Comprehensive Humeral Fracture System (K023063).

Non-Clinical Testing:Mechanical testing was performed on the Verse - Dial™ Humeral Head Non-Chinesis. The testing indicated that the Versa-Dial™ Humeral Head Prosthesis is substantially equivalent to the predicate device.

Clinical testing was not required for this device. Clinical Testing:

All trademarks are property of Biomas, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes extending from its back, symbolizing growth and progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 0 4 2004

Mr. Gary Baker Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K040610

Ko-40010
Trade/Device Name: Versa-Dial™ Humeral Head Prosthesis 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, non-constrained or semiconstrained, porous-coated uncemented prosthesis; and Shoulder joint, humeral (hemi-shoulder), metallic, uncemented prosthesis

Regulatory Class: II Product Code: KWT, KWS, MBF, and HSD Dated: March 5, 2004 Received: March 8, 2004

Dear Mr. Baker:

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 mendments, 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 the rederar Food, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include connois 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 (1 mr), in its , i rise Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Mr. Gary Baker

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least be advised that I Dr o lectures of your device complies with other requirements of the Act that I Dri has made a assud regulations administered by other Federal agencies. You must of any I cacal statutes and registments, including, but not limited to: registration and listing (21 Comply with an the 70th 810 coldentials, with 801); good manufacturing practice requirements as set CITY art 607); adoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in alle quality of belief or visions (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) This letter will anow you to begin maing of substantial equivalence of your device to a legally premation of notication "The 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 n you desire specific acripliance 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 other general mionitational 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,

Sincerely yours,

Mark A. Millerson

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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### Statement of Indications For Use

510(k) Number (IF KNOWN): K040610

Device Name: Versa-Dial™ Humeral Head -

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 tear Difficult cinnoul mailing methods of treatment may not be suitable or may be inadequate.

The Versa-Dial™ Humeral Head Prosthesis is intended for use with the Comprehensive The Versa-Dial - Trainer either cemented or uncemented (press-fit) usc.

The Versa-Dial™ Humeral Head Prosthesis is intended for use with the glenoid The Velsa-Dai- Thumeral Includer System, either all polyethylene for cemented components of the "Ho-Modala" Biological fixation with optional screw fixation) use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <b>X</b> |
|---------------------------------------|------------------------------------------------------|
| OR | Over-the-Counter Use ______ (Optional Format 1-2-96) |

for

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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| 510(k) Number | K040610 |
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Commence of CDRH Office of Device Evaluation (ODE)