DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING

K043374 · Howmedica Osteonics Corp. · MBH · Feb 16, 2005 · Orthopedic

Device Facts

• Record ID: K043374
• Device Name: DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING
• Applicant: Howmedica Osteonics Corp.
• Product Code: MBH · Orthopedic
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duracon® Knee System Patella components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: - Noninflammatory degenerative joint disease including osteoarthritis; traumatic arthritis or avascular necrosis; - Rheumatoid arthritis; - Correction of functional deformity; - Revision procedures where other treatments or devices have failed; - Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, - Irreparable fracture of the knee. These products are intended to achieve fixation without the use of bone cement.

Device Story

Duracon® Conversion and X-Small Patella components are orthopedic implants for total knee arthroplasty; designed to replace articulating surfaces of patella; relieve pain; restore motion; address degenerative bone disease, trauma, or failed prior implants. Device features Peri-Apatite® coating to facilitate cementless fixation to bone. Used in surgical settings by orthopedic surgeons. Output is physical restoration of joint anatomy; clinical decision-making based on patient need for joint replacement. Benefits include pain relief and improved joint function.

Clinical Evidence

Bench testing only. Testing included porous coating characterization, contact area/stress analysis, range of motion/constraint testing, locking mechanism testing, and UHMWPE material properties per Class II Special Controls Guidance. Safety testing performed for Peri-Apatite coating. No clinical data provided.

Technological Characteristics

Patellar components for total knee arthroplasty; metal/polymer construction; Peri-Apatite® coating for cementless fixation. Testing conducted per Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses (Jan 2003).

Indications for Use

Indicated for patients undergoing total knee arthroplasty requiring pain relief and restoration of knee function due to noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision of failed prior treatments, post-traumatic loss of joint anatomy (patello-femoral erosion/dysfunction/patellectomy), or irreparable knee fracture.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Duracon® Conversion and X-Small Symmetric Patella with Porous Coating for uncemented use

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 corporate Boulevard Rockville MD 20850

MAR 3 0 2005

Ms. Denise Duchene Sr. Regulatory Affairs Specialist Howrnedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

Re: K043374

Trade/Device Name: Duracon® Conversion and X-Small Patella with Peri-Apatite® Coating Regulation Numbers: 21 CFR 888.3565 Regulation Names: Knee joint, patellofemorotibial, metal/polymer porous coated uncemented prosthesis Regulatory Class: II Product Codes: MBH Dated: December 2,2004 Received: December 8,2004

Ms. Duchene:

This letter corrects our substantially equivalent letter of February 16, 2005 regarding the incorrect received date of January 8,2004. The correct received date is shown above.

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 (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 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

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#### Page 2- Ms. Denise Duchene

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 continue 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 Complianceat [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.

Styp A. Charles

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I of 1

510(k) Number (if known): K043374

Duracon® Conversion and X-Small Patella with Peri-Apatite® Coating Device Name:

Indications for Use:

The Duracon® Knee System Patella components included in this submission are intended for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as:

- Noninflammatory degenerative joint disease including osteoarthritis; traumatic arthritis or ● avascular necrosis;
- . Rheumatoid arthritis;
- Correction of functional deformity; .
- Revision procedures where other treatments or devices have failed; .
- Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, . dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee. ●

These products are intended to achicve fixation without the use of bone cement.

Prescription Usc

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Mark A. Milken

and Neimingica

ਾਂ ਅਤੇ ਅੰਗ੍ਰੇ ਦੇ ਬਲਵ

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# FEB | 6 2005

## Summary of Safety and Effectiveness

K 043374

| Contact Person: | Denise Duchene<br>Sr. Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Dr.<br>Mahwah, NJ 07430<br>[phone] (Phone)<br>[phone] (FAX) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 12,2004 |
| Device: | Duracon® Conversion and X-Small Symmetric Patella with Peri-<br>Apatite® Coating |
| Classification: | Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated;<br>Uncemented prosthesis - Class II - 21 CFR 888.3565 --Product<br>Code: MBH |
| Predicate Devices: | Duracon® Conversion and X-Small Symmetric Patella with Porous<br>Coating for uncemented use. |
| Indications for Use: | The Duracon® Patella components are for use in total knee<br>arthroplasty to relieve pain and restore knee function for<br>indications such as: noninflammatory degenerative joint disease<br>including osteoarthritis, traumatic arthritis or avascular necrosis;<br>rheumatoid arthritis; correction of functional deformity; revision<br>procedures where other treatments or devices have failed; post<br>traumatic loss of joint anatomy, particularly when there is patello-<br>femoral erosion, dysfunction or prior patellectomy; and,<br>irreparable fracture of the knee. |
| | These products are intended to achieve fixation without the use of<br>bone cement |
| Proposed Modification: | To add a Peri-Apatite® coating to the Conversion and X-Small<br>Symmetrical Patella components. |
| Device Description: | The device patellar components of a total knee system. These<br>components are used for the replacement of the articulating<br>surfaces of the patella to relieve pain, instability and the restriction<br>of motion due to degenerative bone disease, including<br>osteoarthritis, rheumatoid arthritis, failure of other devices or<br>trauma. |

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### Summary of Data:

A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes porous coating characterization, contact area / stress analyses; range of motion range of constraint testing; locking mechanism testing; UHMWPE material properties in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," dated January 16, 2003. The testing also includes safety testing for the Peri-Apatite coating. The results demonstrate that the Duracon Conversion Patella with Porous and Peri-Apatite coatings is safe and effective for use in total knee replacement without bone cement.