SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING

K020703 · Howmedica Osteonics Corp. · JWH · Nov 13, 2002 · Orthopedic

Device Facts

• Record ID: K020703
• Device Name: SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
• Applicant: Howmedica Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scorpio® CR and PS Femoral Components with Titanium Plasma Spray Coating and the Scorpio Tibial Tray with Titanium Plasma Spray Coating are intended for single-use, and are intended to be marketed for cemented fixation only. These femoral components and tibial tray are intended to be used with Osteonics tibial inserts and patellar components in total knee arthroplasty.

Device Story

Scorpio CR and PS femoral components and tibial tray are orthopedic implants for total knee arthroplasty. Subject devices feature titanium plasma spray coating on interior/inferior surfaces to facilitate cemented fixation; replaces MicroStructured porous coating used in predicate devices. Tibial tray design includes 0.75mm increased plate thickness and modified screw hole configuration for greater angulation. Implants are used by orthopedic surgeons in clinical settings to restore knee joint function. Device provides mechanical support and stability for patients with degenerative or post-traumatic joint disease. Clinical benefit derived from improved joint mechanics and pain relief.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Cobalt Chromium (CoCr) alloy substrate with commercially pure (CP) titanium plasma spray coating. Design: Semiconstrained cemented prosthesis. Tibial tray features 0.75mm increased thickness and modified screw hole configuration. Sterilization: Not specified. Connectivity: N/A. Software: N/A.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of joint function, moderate varus/valgus/flexion deformity, or revision of previous knee replacement. Posterior stabilized components are indicated for ligamentous instability or absent/non-functioning posterior cruciate ligament. Contraindicated in patients with active/latent knee infection, mental/neuromuscular disorders risking instability, compromised bone stock, skeletal immaturity, severe instability due to collateral ligament loss, or obesity.

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).

Predicate Devices

• Scorpio CR (K974556)
• Scorpio PS (K962152)
• Osteonics Series 7000 Total Knee System (K910990)
• MCK Total Knee System (Biomet, Inc.)

Reference Devices

• Howmedica Osteonics femoral stems

Submission Summary (Full Text)

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## NOV 1 3 2002

### 510(K) SUMMARY

# Scorpio® CR and PS Femoral Components and Scorpio® Tibial Tray with Titanium Plasma Sprayed Coating

The Scorpio CR and PS Femoral Components with Titanium Plasma Spray Coating, and the Scorpio® Tibial Tray with Titanium Plasma Spray Coating, are substantially equivalent to the predicate Cobalt Chromium alloy (CoCr) MicroStructured® Scorpio® CR (#K974556) and PS (#K962152) femoral components, and the MicroStructured® standard tibial trays of the Osteonics® Series 7000 Total Knee System (#K910990) in all material and design aspects. The following reflect the new characteristics of the subject components:

- The interior surfaces of the subject Scorpio® CR and PS femoral components with 미 Titanium Plasma Spray Coating receive a titanium plasma spray coating instead of the MicroStructured® porous coating. All other design features of the femoral components are identical to the predicate devices.
- For the Scorpio Tibial Tray with Titanium Plasma Spray Coating, the inferior 미 surface of the tibial tray receives a titanium plasma spray coating (as opposed to a MicroStructured® porous coating), and the keel of the tray receives a thin titanium plasma spray coating. The plate of the subject tibial tray is 0.75mm thicker than that of the predicate tibial tray, and has been filled in with cobalt chromium alloy. Also, the screw hole configuration on the titanium plasma sprayed trays has been modified to allow greater angulation of the screws.

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K020703 p 2-1

The plasma-sprayed commercially pure ("CP") Titanium coating is identical to the coating used on the predicate Howmedica Osteonics® femoral stems. The combination of a CoCr substrate and a plasma sprayed CP Titanium coating on a knee component is substantially equivalent to the CoCr substrate/Titanium alloy coating metal combination employed by the legally marketed predicate MCK® Total Knee System manufactured by Biomet, Inc.

#### Intended Use

The Scorpio® CR and PS Femoral Components with Titanium Plasma Spray Coating and the Scorpio Tibial Tray with Titanium Plasma Spray Coating are intended for singleuse, and are intended to be marketed for cemented fixation only. These femoral components and tibial tray are intended to be used with Osteonics tibial inserts and patellar components in total knee arthroplasty. These Scorpio® femoral components and the tibial tray are similar in design to the predicate Scorpio® CR and PS femoral components and Osteonics® Series 7000 tibial tray, with the exception the titanium plasma spray coating.

The following are the specific indications/contraindications for the Scorpio® CR and PS femoral components with Titanium Plasma Sprayed Coating, and the Scorpio® Tibial Tray with Titanium Plasma Sprayed Coating:

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510(k) Summary Scorpio® CR and PS Femoral Components and Tibial Tray with Titanium Plasma Spray Coating

#### Indications:

- . 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 Posterior Stabilized Components:

- Ligamentous instability requiring implant bearing surface geometries with increased ● constraint.
- . Absent or non-functioning posterior cruciate ligament.

#### Contraindications:

The contraindications for the subject devices include:

- . Any active or suspected latent infection in or about the knee joint.
- . Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
- Bone stock compromised by disease, infection or prior implantation which cannot ● provide adequate support and/or fixation to the prosthesis.
- . Skeletal immaturity

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510(k) Summary Scorpio® CR and PS Femoral Components and Tibial Tray with Titanium Plasma Spray Coating

- Severe instability of the knee joint secondary to the absence of collateral ligament . integrity and function.
- Obesity. An overweight or obese patient can produce loads on the prosthesis . which can lead to failure of the fixation of the device or to failure of the device itself.

Testing was provided to support the claim of substantial equivalence.

For further information contact: Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401 [phone] (Telephone) [phone] (Fax)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that appears to be three abstract shapes stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret F. Crowe Regulatory Affairs Consultant Stryker® Howmedica Osteonics 59 Route 17 South Allendale, New Jersey 07401

Re: K020703

Trade/Device Name: Scorpio® CR and PS Femoral Components and Tibial Tray with Titanium Plasma Spray Coating Regulation Number: 21 CFR §888.3560 Regulation Name: Knee joint, patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis

Regulatory Class: Class II Product Code: JWH Dated: August 22, 2002 Received: August 23, 2002

Dear Ms. Crowe:

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.

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Page 2 - Ms. Margaret F. Crowe -

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely vours.

L. Mark A. Mellmann

elia 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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#### INDICATIONS FOR USE

510(k) Number (if known): KO20203

Device Name: Scorpio® CR and PS Femoral Components and Scorpio® Tibial Tray with Titanium Plasma Spray Coating

#### Indications for Use:

The Scorpio® CR and PS Femoral Components with Titanium Plasma Spray Coating and the Scorpio Tibial Tray with Titanium Plasma Spray Coating are intended for single-use, and are intended to be marketed for cemented fixation only. These femoral components and tibial tray are intended to be used with Osteonics tibial inserts and patellar components in total knee arthroplasty.

The following are the specific indications/contraindications for the Scorpio® CR and PS femoral components with Titanium Plasma Sprayed Coating, and the Scorpio Tibial Tray with Titanium Plasma Sprayed Coating:

#### Indications:

- 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 Posterior Stabilized Components:

- Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.

#### Contraindications:

The contraindications for the subject devices include:

- Any active or suspected latent infection in or about the knee joint.
- Any mental or neuromuscular disorder which would create an unacceptable risk
- of prosthesis instability, prosthesis fixation failure or complications in postoperative care.

Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.

- Skeletal immaturity
Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.

Obesity. An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device itself.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109) ·

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Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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(Division Sign
Dision of Curl Rustorative
and Neurological Devices

510(k) Number K020703

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