ZIMMER PATELLOFEMORAL JOINT PROSTHESIS

K070695 · Zimmer, Inc. · KRR · Jun 7, 2007 · Orthopedic

Device Facts

• Record ID: K070695
• Device Name: ZIMMER PATELLOFEMORAL JOINT PROSTHESIS
• Applicant: Zimmer, Inc.
• Product Code: KRR · Orthopedic
• Decision Date: Jun 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

-Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint; -The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation); -History of patellar dislocation or patella fracture; -Dysplasia-induced degeneration This device is intended for cemented use only.

Device Story

Zimmer Patellofemoral Joint (PFJ) Prosthesis; knee prosthesis component designed to replicate femoral patellar groove anatomy. Incorporates NexGen knee system frontal profile geometry for patella tracking; accommodates resurfaced and unresurfaced patellas. Available in five sizes; left and right configurations. Implanted by orthopedic surgeons in clinical settings to address patellofemoral joint degeneration or failure of previous surgeries. Device provides mechanical replacement of articulating surface; intended for cemented fixation. Benefits include restoration of joint function and stability for patients with specified arthritic or traumatic conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Non-clinical performance testing demonstrated the device meets requirements and is as safe and effective as the predicate devices.

Technological Characteristics

Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis. Design replicates femoral patellar groove anatomy using NexGen knee system frontal profile geometry. Five sizes available in left/right configurations. Cemented fixation.

Indications for Use

Indicated for patients with osteoarthritis, traumatic arthritis, polyarthritis, severe chondrocalcinosis of the patellofemoral joint, dysplasia-induced degeneration, history of patellar dislocation or fracture, or salvage of failed prior surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). Intended for cemented use only.

Regulatory Classification

Identification

A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.

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)) Applications for Orthopedic Devices,” and (v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and (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 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and (viii) 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 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and (viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”

Predicate Devices

• Stryker Compartmental Knee System (K052917)
• Natural-Knee® II Patellofemoral Joint Prosthesis (K002356)
• NexGen® Knee Gender Solutions Female Femoral Components (K060370)

Submission Summary (Full Text)

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K070695

# JUN - 7 2007

# Summary of Safety and Effectiveness

| Submitter: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley<br>Senior Associate, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | June 4, 2007 |
| Trade Name: | Zimmer® Patellofemoral Joint Prosthesis |
| Common Name: | Knee Prosthesis Component |
| Classification Name<br>and Reference: | Knee joint patellofemoral polymer/metal semi-<br>constrained cemented prosthesis<br>21 CFR § 888.3540 |
| Predicate Device: | Stryker Compartmental Knee System, manufactured<br>by Howmedica Osteonics Corp., K052917, cleared<br>December 27, 2005<br><br>Natural-Knee® II Patellofemoral Joint Prosthesis,<br>manufactured by Zimmer, Inc., K002356, cleared<br>October 30, 2000<br><br>NexGen® Knee Gender Solutions Female Femoral<br>Components, manufactured by Zimmer, Inc.,<br>K060370, cleared April 28, 2006 |
| Device Description: | The Zimmer Patellofemoral Joint (PFJ) Prosthesis is<br>designed to closely replicate the anatomic features<br>of the patellar groove on the femur. The implant's<br>articulating surface incorporates the NexGen® knee<br>system's frontal profile geometry for optimal patella<br>tracking for both resurfaced and unresurfaced<br>patellas. The construct of the PFJ prosthesis<br>accommodates a wide range of patients, both female<br>and male. Five sizes in left and right configurations |
| Intended Use: | -Osteoarthritis, traumatic arthritis, polyarthritis,<br>and/or severe chondrocalcinosis of the<br>patellofemoral joint;<br>-The salvage of previously failed surgical attempts<br>(e.g., arthroscopy, lateral release, cartilage<br>transplantation);<br>-History of patellar dislocation or patella fracture;<br>-Dysplasia-induced degeneration<br>This device is intended for cemented use only. |
| Comparison to Predicate Device: | The Zimmer Patellofemoral Joint Prosthesis is<br>packaged, manufactured, and sterilized using the<br>same materials and processes as the predicate<br>devices. The subject device also has the same<br>intended use and similar fixation methods as the<br>predicate devices. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>Non-clinical testing demonstrated that the Zimmer<br>Patellofemoral Joint Prosthesis met performance<br>requirements and is as safe and effective as the<br>predicate devices. |

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are being offered for this implant.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### JUN - 7 2007

Zimmer, Inc. % Ms. Dalene T. Binkley M.S., RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K070695 Trade/Device Name: Zimmer® Patellofemoral Joint Prosthesis Regulation Number: 21 CFR 888.3540 Regulation Name: Knee joint patellofemoral polymer/metal semi-constrained Cemented prosthesis Regulatory Class: Class II Product Code: KRR Dated: March 12, 2007 Received: March 13, 2007

Dear Ms. Binkley:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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

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Page 2 – Ms. Dalene T. Binkley M.S., RAC

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your devices as described in your Section 510(k) rms lotter will and my Jorve FDA finding of substantial equivalence of your devices to a legally premation notificate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please If you desire specific acreed 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 general informational and Consumer Assistance at toll-free number [phone] or [phone] or on the Internet address http://www.fda.gov/odrh/industry/support/index.html.

Sincerely yours,

Carbone Buehr

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

K070695

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

Device Name:

Zimmer® Patellofemoral Joint Prosthesis

Indications for Use:

-Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe

chondrocalcinosis of the patellofemoral joint;

chondrocalchiosis of the patchoremoral joints,
-The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation),

-History of patellar dislocation or patella fracture;

-Dysplasia-induced degeneration

This device is intended for cemented use only.

Prescription Use _X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

tenbas breens

Division of General, Restorative, and Neurological Devices

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510(k) Number k070695

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