STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION

K082567 · Howmedica Osteonics Corp. · HRY · Oct 3, 2008 · Orthopedic

Device Facts

• Record ID: K082567
• Device Name: STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
• Applicant: Howmedica Osteonics Corp.
• Product Code: HRY · Orthopedic
• Decision Date: Oct 3, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3530
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker® Compartmental Knee System Line Extension consists of sterile, single-usc devices intended for replacement of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The Stryker® Compartmental Knee System Line Extension includes Triathlon® PKR femoral condyle regions for cither the right or left knee.

Device Story

System of sterile, single-use orthopedic implants for patellofemoral and/or unicondylar knee arthroplasty; includes Triathlon® PKR femoral condyle components. Used by orthopedic surgeons in clinical settings to replace damaged joint surfaces. Implants are fixed using bone cement. Device allows surgeons to combine components from existing Howmedica Osteonics knee systems to address specific patient anatomy and pathology; provides mechanical restoration of joint function; reduces pain; improves mobility in patients with degenerative or post-traumatic joint disease.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use compatibility with existing marketed systems.

Technological Characteristics

Metal/polymer semi-constrained cemented knee prosthesis. Components sourced from existing Howmedica Osteonics knee systems. Single-use; requires bone cement for fixation.

Indications for Use

Indicated for cemented patellofemoral and/or unicondylar arthroplasty in patients with conditions unaddressable by a single device. Applicable for degenerative arthritis of distal femur/patella; history of patellar dislocation or fracture; failed previous surgeries (arthroscopy, tibial tubercle elevation, lateral release); moderately disabling osteo- or post-traumatic arthritis; revision of previous unsuccessful procedures; alternative to tibial osteotomy for unicompartmental osteoarthritis; or poor bone stock/deficiencies of femoral condyle/tibial plateau.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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K082567

# OCT 3 - 2008

### Summary of Safety and Effectiveness Stryker® Compartmental Knee System Line Extension

| Proprietary Name: | Stryker® Compartmental Knee System Line Extension |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Knee Prosthesis |
| Classification Name and Reference: | Knee joint femortotibial polymer/metal semi constrained cemented prosthesis. 21 CFR §888.3530 |
| | Knee joint patellofemoral polymer/metal semi constrained cemented prosthesis. 21 CFR §888.3540 |
| | Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. 21 CFR §888.3520 |
| | Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis. 21 CFR §888.3530 |
| Device Product Code: | 87 NPJ, 87 KRR, 87 HSX, 87 HRY |
| For Information Contact: | Francisco Haro, Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | September 3, 2008 |

#### Description:

The Stryker® Compartmental Knee System consists of sterile, single-use components intended for replacement of the femoral side of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Ostconics' knee systems for patellofemoral and unicondylar arthroplasty. The system allows the physician to choose the most appropriate option to treat the patient with patellofemoral arthroplasty and/or unicondylar arthroplasty as needed.

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#### Intended Use:

The Stryker® Compartmental Knee System Line Extension consists of sterile, single-usc devices intended for replacement of the patellofemoral joint and/or the condyle region(s) of the femoral joint as needed. The Stryker® Compartmental Knee System Line Extension includes Triathlon® PKR femoral condyle regions for cither the right or left knee.

#### Indications for Use:

The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knee System include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following conditions:

- . Degenerative arthritis in the distal femur and patella.
- Patients with a history of patellar dislocation or patella fracture, .
- . Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists,
- . Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knec prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, . or
- Where bone stock is of poor quality or inadequate for other reconstructive techniques . as indicated by deficiencies of the femoral condvle/tibial plateau.

These components are single use only and are intended for implantation with bone cement only.

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## Substantial Equivalence:

The device is substantially equivalent to its predicates for patellofemoral arthroplasty and femorotibial arthroplasty in regards to intended use, design, materials, and operational principles. The analysis demonstrated that the components from these systems are compatible when used for patellofemoral and/or femorotibial replacement.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined strands and a wing-like structure above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

OCT 3 - 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Francisco Haro Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K082567

Trade/Device Name: Stryker® Compartmental Knee System Line Extension Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Codes: IIRY, NPJ, HSX, KRR Dated: September 3, 2008 Received: September 4, 2008

Dear Mr. Francisco Haro:

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 l'ood, 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 gencral 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.

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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.

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 Biometrics' (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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mikkelson

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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K082567 510(k) Number (if known):

Device Name: Stryker® Compartmental Knec System Line Extension

Indications for Use;

The Stryker® Compartmental Knee System line extension is intended for use in cemented patellofemoral and/or unicondylar arthroplasty in patients where conditions exist that cannot be addressed by a single device to treat the femorotibial or patellofemoral regions of the knee. The indications for the different components of the Stryker® Compartmental Knec System line extension include conditions when the patellofemoral and/or condylar region(s) have been affected by one or more of the following conditions:

- . Degenerative arthritis in the distal femur and patella,
- . Patients with a history of patellar dislocation or patella fracture,
- . Patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists,
- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis,
- . Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, . or
- . Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.

These components are single use only and are intended for implantation with bone cement.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Mark Mill

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative,

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Division of Anesthesiology, General Hospital

Division of General, Restorative, and Neurological Devices

Infection Control, Dental Devices
510(k) Number:

510(k) Number