DISCOVERY ELBOW - X-SMALL

K090473 · Biomet Manufacturing Corp · JDC · Mar 25, 2009 · Orthopedic

Device Facts

• Record ID: K090473
• Device Name: DISCOVERY ELBOW - X-SMALL
• Applicant: Biomet Manufacturing Corp
• Product Code: JDC · Orthopedic
• Decision Date: Mar 25, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indications for use for the Discovery™ Elbow - X-Small 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. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods. The device is intended for use with bone cement.

Device Story

Total elbow prosthesis; consists of ulnar and humeral components; humeral articulation links through ulnar articulation. Humeral components available with/without flange; components available with smooth or roughened surfaces. X-Small size variant. Intended for cemented fixation. Used by orthopedic surgeons in clinical/surgical settings to replace diseased or fractured elbow joints; restores joint function and reduces pain.

Clinical Evidence

No clinical data provided; substantial equivalence based on non-clinical laboratory testing.

Technological Characteristics

Metal/polymer constrained cemented elbow prosthesis. Components include ulnar and humeral parts. Available with smooth or roughened surface finishes. X-Small size.

Indications for Use

Indicated for patients requiring total elbow arthroplasty due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, failed prior treatments/revisions, functional deformity, or acute/chronic fractures with humeral epicondyle involvement.

Regulatory Classification

Identification

An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,” (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,” (vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and (viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,” (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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,” (v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,” (vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,” (vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and (viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”

Predicate Devices

• Discovery™ Elbow (K013042)
• Discovery™ Elbow (K051975)

Submission Summary (Full Text)

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MAR 2 5 2009

Image /page/0/Picture/1 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a stylized font with a geometric design. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The text is black and the background is white.

### 510(k) Summary

| 510(k) Number: | K090473 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Preparation Date: | March 24, 2009 |
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Patricia Sandborn Beres<br>Senior Regulatory Specialist<br>Biomet Manufacturing Corp.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0578 |
| Proprietary Name: | Discovery™ Elbow - X-Small |
| Common Name: | Elbow Prosthesis |
| Classification Name: | Elbow joint metal/polymer constrained cemented prosthesis<br>(21 CFR 888.3150) |

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The predicate device is the Discovery™ Elbow, originally cleared through 510(k) K013042, on October 10, 2001 and modified on through 510(k) K051975 cleared on September 6, 2005.

Device Description: The Discovery™ Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. Placing the humeral articulation through the ulnar articulation links the ulnar and humeral component. The humeral components are available with or without a flange. The numeral and ulnar components are avialalbe with either a smooth or roughened surface. The components contained in this submission are X-Small in size.

Intended Use: The indications for use for the Discovery™ Elbow - X-Small 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,

Mailing Address PO Rox 587 Warsaw, IN 46581 0587 Toll Free: 800,348,9600 Ollice: 574 757 6639 Hain Fax: [phone] 1100000 11001

Skinning Address Frast 36-1 300 F Warsay IN 46597

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510(k) Summary K090473 - Discovery Elbow - X-Small Page 2

- 5. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods.
The device is intended for use with bone cement.

Summary of Technologies: The Discovery™ Elbow X-Small has similar or identical technologies to the predicate devices.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

## MAR 2 5 2009

Biomet Manufacturing Corp. % Ms. Patricia Sandborn Beres P.O. Box 587 Warsaw, Indiana 46581-0578

Re: K090473

Trade/Device Name: Discovery Elbow - X-Small Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: JDC Dated: February 20, 2009 Received: February 24, 2009

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 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.

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### Page 2 - Ms. Patricia Sandborn Beres

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

જિલ્લાઓ પૈકીના એક એવા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Discovery Elbow - X-Small

Indications For Use: The Discovery Elbow - X-Small is intended for cemented use in patients with the following conditions:

- 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. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods

Prescription Use X . (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

O. O. Rumm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K09047

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