SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS

K051977 · Howmedica Osteonics Corp. · JWH · Oct 12, 2005 · Orthopedic

Device Facts

• Record ID: K051977
• Device Name: SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
• Applicant: Howmedica Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Oct 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio X3™ UHMWPE all polyethylene patellar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or cementless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio X3™ UHMWPE patellar components are intended for implantation with bone cement only. The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented Scorpio® TS femoral components and the cemented Scorpio® or Series 7000 tibial trays in primary or revision total knee arthroplasty. The Scorpio® Knee System components are for use in total knee arthroplasty as a result of: 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. Additional indications for Total Stabilized (TS) Components: Severe anteroposterior and medial/lateral instability of the knee.

Device Story

Scorpio® X3™ UHMWPE tibial inserts and patellar components are orthopedic implants for total knee arthroplasty. The device features UHMWPE material modified via a proprietary sequential crosslinking and annealing process. Tibial inserts are available in Cruciate Retaining, Posterior Stabilized, and Total Stabilizing designs; patellar components in Medialized, Concentric, Universal, Recessed, and Inset dome designs. Implants are used by orthopedic surgeons in clinical settings to replace bearing/articulating surfaces of the proximal tibia and patella. The device is intended to restore joint function and stability in patients with degenerative, rheumatoid, or post-traumatic arthritis, or following revision of previous unsuccessful procedures. The X3™ material modification aims to improve wear characteristics compared to standard UHMWPE.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and engineering analysis, including material properties characterization, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing, and finite element modeling of contact stresses.

Technological Characteristics

UHMWPE (Ultra-High Molecular Weight Polyethylene) tibial inserts and patellar components. Features proprietary sequential crosslinking and annealing process. Designs include Cruciate Retaining, Posterior Stabilized, and Total Stabilizing tibial inserts; various dome-shaped patellar components. Intended for use with cemented or cementless femoral and tibial tray components.

Indications for Use

Indicated for patients requiring primary or revision total knee arthroplasty due to painful, disabling joint disease (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of joint function, or moderate varus, valgus, or flexion deformity. Posterior Stabilized components indicated for ligamentous instability or absent/non-functioning posterior cruciate ligament. Total Stabilized components indicated for severe anteroposterior and medial/lateral instability.

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® Polyethylene Tibial Inserts and Scorpio® Polyethylene Patellar Components

Submission Summary (Full Text)

{0}------------------------------------------------

P. 1/2

# 510(k) Summary of Safety and Effectiveness

| Device: | Scorpio® X3™ UHMWPE Tibial Inserts and Scorpio®<br>X3™ UHMWPE Patellar Components |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | 21 CFR 888.3560 - Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis |
| | 21 CFR 888.3565 - Knee joint patellofemorotibial<br>metal/polymer porous-coated uncemented prosthesis |
| Product Code | 87 JWH, 87 MBH |
| Predicate Devices: | Scorpio® Polyethylene Tibial Inserts and Scorpio®<br>Polyethylene Patellar Components |
| Contact Person: | Karen Ariemma<br>Senior Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>[phone]<br>[phone] (FAX)<br>[e-mail] |

Date Summary Prepared: September 28, 2005

#### Device Description

The device includes tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the proximal tibia and patclla. The modification to the device subject of this premarket notification is the sequentially crosslinking and annealing of the UHMWPE material by a proprietary process. Tibial inserts will be made in Cruciate Retaining, Posterior Stabilized and Total Stabilizing designs. Patellar components will be made in Medialized Dome, Concentric Dome, Universal Dome, Recessed and Inset designs

#### Indications For Use

The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio® X3TM UHMWPE all polyethylene patellar components are intended to be used with cemented or cementless Scorpio femoral components, cemented or ccmcntless Series 7000 tibial tray components and cemented Scorpio® tibial tray components in primary or revision total knee arthroplasty. The all polyethylene Scorpio 6 X3™ UHMWPE patellar components are intended for implantation with bone cement only.

{1}------------------------------------------------

051977

The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented Scorpio TS femoral components and the cemented Scorpio or Series 7000 tibial trays in primary or revision total knec arthroplasty.

The Scorpio® Knee System components are for use in total knee atthroplasty as a result of:

- Painful, disabling joint disease of the knee resulting from degencrative athritis, 후 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. .

Additional indications for Total Stabilized (TS) Components:

- Severe anteroposterior and medial/lateral instability of the knee. .
### Summary of Data

Sunning you Data equivalence of the subject products to the predicate devices. Testing and analysis includes material properties characterization, wear testing, disassembly force evaluation, multi-axis fatigue testing, patella shear testing and finite element modeling of contact stresses.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

0CT 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karen Ariemma Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430

Re: K051977

Trade/Device Name: Scorpio Knee System-Tibial Inserts and Patellar Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH, MBH Dated: July 19, 2005 Received: July 21, 2005

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Docker on (c) f
referenced above and have determined the device is substantially equivalent (for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce uss stated in the energies in the Medical Device Amendments, or to devices that provision in the provisions 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 thereone, manier the act include requirements for annual registration, listing of devices, good controls pro risions one 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 rr your are rise 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 or any I 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.

{3}------------------------------------------------

## Page 2- Karen Ariemma

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter watification. 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/cdrl/industry/support/index.html.

Sincerely yours,

Mark N. Mello

Co Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# K051977

510(k) Number (if known): _

Device Name: Scorpio Knec System - Tibial Inserts and Patellar Components

Indications for Use:

The Scorpio® X3™ UHMWPE Cruciate Retaining and Posterior Stabilized tibial inserts and the Scorpio X3™ UHMWPE all polyethylene patcllar components are intended to be used with Scorpio X3 ™ UHM WFL all polychylono parents, cemented or cementless Senies 7000 tibian total local cemented of cementiess Scopio" ithink tibiable and components in primary or revision total knews are interested arthroplasty. The all polyethylene Scorpio X3M UHMWPE patellar components are intended for implantation with bone cement only.

The Scorpio® X3™ Total Stabilizer tibial inserts are intended to be used with the cemented The Scorpio" X31" Total Stannisci dollar inserts are theirder woo cores.
Scorpio" TS femoral components and the cemented Scorpio" or Series 7000 tibial trays in primary or revision total knee arthroplasty.

The Scorpio " Knee System components are for use in total kncc arthroplasty as a result of:

- 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. .
- Fost-traumance 1033 or know John version ity 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:

- hial intuceatous for I overlex oring implant bearing surface geometries with increased . constraint
- Absent or non-functioning posterior cruciate ligament. .

Additional indications for Total Stabilized (TS) Components:

- Severe anteroposterior and medial/lateral instability of the knee joint. .
Prescription Use X (Per 21 CFR 801.109)

OR

Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEBDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

2

Page 1 of l

(Division Sign-Off) Division of General, Restorative, and Neumlogical De

510(k) Number K051977