DURACON TOTAL KNEE SYSTEM

K032163 · Howmedica Osteonics Corp. · MBH · Sep 12, 2003 · Orthopedic

Device Facts

• Record ID: K032163
• Device Name: DURACON TOTAL KNEE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MBH · Orthopedic
• Decision Date: Sep 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duracon® Total Knee System 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 with and without the use of bone cement.

Device Story

Duracon® Total Knee System consists of femoral, tibial, and patellar components for total knee arthroplasty; replaces bearing/articulating surfaces of distal femur and proximal tibia. Used to relieve pain, instability, and motion restriction caused by degenerative bone disease, trauma, or prior device failure. Components allow for fixation with or without bone cement. Implanted by orthopedic surgeons in clinical/hospital settings. Benefits include restoration of knee function and pain relief.

Clinical Evidence

No clinical data. Equivalence supported by bench testing including porous coating characterization, baseplate fatigue testing, contact area/stress analyses, range of motion/constraint testing, locking mechanism testing, and UHMWPe material property verification per FDA guidance.

Technological Characteristics

Metal/polymer porous-coated uncemented prosthesis. Components include femoral, tibial, and patellar parts. Materials include UHMWPe. Testing performed per Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses (Jan 16, 2003).

Indications for Use

Indicated for patients requiring total knee arthroplasty to relieve pain and restore function due to noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), rheumatoid arthritis, functional deformity, revision of failed prior treatments, post-traumatic joint anatomy loss (patellofemoral 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® Total Knee System (K032163)

Submission Summary (Full Text)

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Duracon® Total Knee System

SEP 1 2 2003

K032163

## Summary of Safety and Effectiveness

| Contact Person: | Denise Duchene<br>Sr. Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>59 Route 17 South<br>Allendale, NJ 07401<br>[phone] (Phone)<br>[phone] (FAX) |
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| Date: | June 24, 2003 |
| Device: | Duracon® Total Knee System |
| Classification: | Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated;<br>Uncemented prosthesis - Class II - 21 CFR 888.3565 |
| Predicate Devices: | Duracon® Total Knee System |
| Indications for Use: | The Duracon® Total Knee System components are for use in total<br>knee 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.<br><br>These products are intended to achieve fixation with and without<br>the use of bone cement |
| Proposed Modification: | Additional indication for use of product without bone cement. |
| Device Description: | The device includes femoral, tibial and patellar components of a<br>total knee system. These components are used for the replacement<br>of the bearing and/or articulating surfaces of the distal femur,<br>proximal tibia to relieve pain, instability and the restriction of<br>motion due to degenerative bone disease, including osteoarthritis,<br>rheumatoid arthritis, failure of other devices or trauma. |

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K032163

## 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, baseplate fatigue testing, 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 results demonstrate that the Duracon Total Knee System meets the requirements of this document.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2003

Ms. Denise Duchene Senior Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401

Re: K032163 Trade/Device Name: Duraco® Total Knee System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. Product Code: MBH Dated: July 11, 2003 Received: July 21, 2003

Dear Ms. Duchene:

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. Denise Duchene

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,

Miriam C. Provost

Col 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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K032163 510(k) Number (if known):

Device Name: Duracon® Total_Knee System

Indications for Use:

The Duracon® Total Knee System 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 with and without the use of bone cement.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Prescription Use

OR Over-the-Counter Use (Per 21 CFR 801.109)

Miriam C. Provost
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K032163