SCORPIO TOTAL KNEE SYSTEM

K033972 · Howmedica Osteonics Corp. · MBH · Apr 12, 2004 · Orthopedic

Device Facts

• Record ID: K033972
• Device Name: SCORPIO TOTAL KNEE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MBH · Orthopedic
• Decision Date: Apr 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scorpio® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; post-traumatic loss of knee joint configuration and function; moderate varus, valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability; revision of previous unsuccessful knee replacement or other procedure. Additional indications for the posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; absent or non-functioning posterior cruciate ligament. These products are intended to achieve fixation with and without the use of bone cement

Device Story

Scorpio® Total Knee System consists of femoral, tibial, and patellar components designed for total knee arthroplasty. Device replaces articulating surfaces of distal femur, proximal tibia, and patella to relieve pain and restore motion. Used in clinical settings by orthopedic surgeons. Implantation performed with or without bone cement. System provides mechanical stability and restores joint function for patients with degenerative bone disease or trauma. Benefits include pain relief and improved mobility.

Clinical Evidence

Bench testing only. Testing included porous coating characterization, baseplate fatigue testing, contact area/stress analyses, range of motion/constraint testing, locking mechanism testing, and UHMWPE material property evaluation in accordance with FDA Class II Special Controls Guidance.

Technological Characteristics

Metal/polymer, porous-coated, uncemented prosthesis. Components include femoral, tibial, and patellar implants. Materials include UHMWPE. Testing performed per Class II Special Controls Guidance for Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses.

Indications for Use

Indicated for patients requiring total knee arthroplasty due to degenerative, rheumatoid, or post-traumatic arthritis; post-traumatic loss of joint function; or moderate varus, valgus, or flexion deformity with stable ligaments. Also indicated for revision of failed knee replacements. Posterior stabilized components indicated for ligamentous instability or absent/non-functioning posterior cruciate ligament. Single use only.

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

• Scorpio® Total Knee System

Submission Summary (Full Text)

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Scorp10® Total Knee System

## APR 1 2 2004

510(k) Premarket Notification K033972

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## Summary of Safety and Effectiveness

| 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: | December 4, 2003 |
| Device: | Scorpio® Total Knee System |
| Classification: | Knee Joint; Patellofemorotibial; Metal/polymer; Porous-coated;<br>Uncemented prosthesis - Class II - 21 CFR 888.3565 |
| Predicate Devices: | Scorpio® Total Knee System |
| Indications for Use: | The Scorpio® Total Knee System components are for use in total<br>knee arthroplasty to relieve pain and restore knee function for<br>indications such as: painful, disabling joint disease of the knee<br>resulting from degenerative arthritis, rheumatoid arthritis or post-<br>traumatic arthritis; post-traumatic loss of knee joint configuration<br>and function; moderate varus, valgus or flexion deformity in which<br>the ligamentous structures can be returned to adequate function<br>and stability; revision of previous unsuccessful knee replacement<br>or other procedure. Additional indications for the posterior<br>stabilized components include: ligamentous instability requiring<br>implant bearing surface geometries with increased constraint;<br>absent or non-functioning posterior cruciate ligament.<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 and patella to relieve pain, instability and the<br>restriction 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, baseplate fatigue testing, contact area / stress analyses; range of motion range / range of constraint testing; locking mechanism testing; and 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 Scorpio® Total Knee System mects the requirements of this document.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 2004

Ms. Denise Duchene Srenior Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430

Re: K033972 Trade/Device Name: Scorpio® Total Knee System Regulation Numbers: 21 CFR 888.3565 Regulation Names: Knee joint, patellofemorotibial metal/polymer, porous-coated uncemented prosthesis Regulatory Class: II Product Codes: MBH Dated: March 23, 2004 Received: March 24, 2004

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 rcclassified 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, labcling, 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 Fedcral 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,

Sincerely, yours,

Mark A. Mcpherson

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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K033972 510(k) Number (if known):

Device Name: Scorpio® Total Knee System

Indications for Use:

The Scorpio Total Knec 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:

- Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis
- Post-traumatic loss of knee joint configuration and function .
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability;
- Revision of previous unsuccessful knee replacement or other procedure; .

Additional indications for the posterior stabilized components include:

- Ligamentous instability requiring implant bearing surface gcometrics with increased . constraint
- Absent or non-functioning postcrior cruciate ligament t

These components are single use only and are intended for implantation with and without bone cement.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of D Division of General, Restorative. and New ological D Prescription Use OR (Per 21 CFR 801.109)