STRYKER COMPARTMENTAL KNEE SYSTEM

K052917 · Howmedica Osteonics Corp. · NPJ · Dec 27, 2005 · Orthopedic

Device Facts

• Record ID: K052917
• Device Name: STRYKER COMPARTMENTAL KNEE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: NPJ · Orthopedic
• Decision Date: Dec 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 an 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.

Device Story

Stryker Compartmental Knee System comprises sterile, single-use patellofemoral, femoral, and tibial components; derived from existing Howmedica Osteonics knee systems. Used by surgeons in clinical settings for patellofemoral and/or unicondylar arthroplasty. Components implanted using bone cement; allows physician to combine components to address specific patient anatomy where single-device solutions are insufficient. Benefits include restoration of joint function and pain relief for patients with localized knee disease.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material compatibility with previously cleared components.

Technological Characteristics

System consists of metal and polymer components for cemented implantation. Design utilizes existing components from Howmedica Osteonics knee systems. Single-use, sterile, semi-constrained prosthesis.

Indications for Use

Indicated for patients with degenerative arthritis of distal femur/patella, history of patellar dislocation/fracture, failed prior knee surgery, moderately disabling osteo- or post-traumatic arthritis, revision of unsuccessful prior procedures, or as alternative to tibial osteotomy where bone stock is inadequate for other techniques.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Submission Summary (Full Text)

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## DEC 2 7 2005

# 510(k) Summary of Safety and Effectiveness Stryker® Compartmental Knee System

#### Submission Information

| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>325 Corporate Drive<br>Mahwah, NJ 07430 |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] |
| Date Summary Prepared: | December 9, 2005 |
| Device Identification<br>Proprietary Name:<br>Common Name:<br>Proposed Regulatory Class: | Stryker® Compartmental Knee System<br>Knee Prosthesis Components<br>Class II |

## Classification Name, Reference and Product Code:

Classificanon Name, Netal, Semi-constrained, Cemented Prosthesis, 21 CFR §888.3530, 87 NPJ Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis, 21 CFR 888.3540, 87 KRR Riles John Patononomal por J. Mon-Constrained, Cemented, Metal Polymer, 21 CFR 888.3520, 87 HSX I Tosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer, 21 CFR §888.3530, 87 HRY

### Description:

The Stryker® Compartmental Knee System consists of sterile, single-use components intended for r ne our new - Companiside of the patellofemoral joint and/or the condyle region(s) of the femoral rophoominent of the system includes patellofemoral, femoral, and tibial components from currently marketed Howmedica Osteonics' 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.

#### Indications for Use

The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral and/or The only ar 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 companents 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 an unicompartmental knee prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, or .

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- 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.

#### Substantial Equivalence:

Substantial Equivalent to its predicates for patellofemoral arthroplasty and femorotibial The device is substantially equivalent to this promaterials, and operational principles. The analyses armonstrate that the components from these systems are compatible when used for patellofemoral and/or femorotibial replacement.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 2005

Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430

K052917 Re:

Trade/Device Name: Stryker Compartmental Knee System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: NPJ, KRR, HSX, HRY Dated: December 13, 2005 Received: December 13, 2005

Dear Ms. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocation of 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 commerce provided 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). and Cosmetic Free (110) keep the device, subject to the general controls provisions of the Act. The r ou may , the so received 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 docs 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

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#### Page 2 - Ms. Vivian Kelly

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quart) Bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxilation control po begin marketing your device as described in your Section 510(k) I ms letter will and w you to ough finding of substantial equivalence of your device to a legally prematication. The PDF intentig sification 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 If you desire specific darioliance 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 other general micronational 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. Melkerson

to

Acting 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: Stryker® Compartmental Knee System

Indications for Use:

The Stryker® Compartmental Knee System is intended to be used in cemented patellofemoral The Our your which - Compariminents where conditions exist that cannot be addressed by a and of annoonal the femorotibial or patellofemoral regions of the knee. The indications for single device to treat and remorederer of 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 knee prosthesis,
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, or .
- r is an atternation 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 | AND/OR | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

| 510(k) Number | K052917 |
|---------------|---------|
|---------------|---------|

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