← Product Code [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH) · K033342

# SCORPIO KNEE SYSTEM - TIBIAL INSERTS (K033342)

_Howmedica Osteonics Corp. · JWH · Jan 15, 2004 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K033342

## Device Facts

- **Applicant:** Howmedica Osteonics Corp.
- **Product Code:** [JWH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH.md)
- **Decision Date:** Jan 15, 2004
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3560
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Scorpio® Knee System tibial insert components are for use in total knee arthroplasty for 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 with the ligamentous structures can be returned to adequate function and stability; and/or revision of previous unsuccessful knee replacement or other procedure.

## Device Story

Scorpio Knee System tibial inserts are orthopedic implants used in total knee arthroplasty. These components replace the bearing surface of the proximal tibia to relieve pain, instability, and restricted motion caused by degenerative bone disease, trauma, or previous implant failure. The device is intended for single-use and requires implantation with bone cement. The modification involves redesigned dimensions to improve hyperextension and a new claim for the CR insert to provide sufficient constraint when the posterior cruciate ligament is absent or non-functioning. Surgeons implant these devices in a clinical/OR setting to restore joint function and stability.

## Clinical Evidence

Bench testing only. No clinical data provided. Testing included range of constraint, tibial insert post stress, and contact stress/area analysis to demonstrate equivalence.

## Technological Characteristics

Polymer/metal/polymer semi-constrained cemented prosthesis. Tibial insert component. Designed for total knee arthroplasty. Materials and specifications not detailed beyond classification as a polymer/metal/polymer system.

## Regulatory 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® Knee System - Tibial Inserts ([K033342](/device/K033342.md))

## Submission Summary (Full Text)

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| K033342                       |
|-------------------------------|
| 510(k) Premarket Notification |

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## JAN 1 5 2004

## Summary of Safety and Effectiveness

| Contact Person:        | Denise Duchene<br>Sr. Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>59 Route 17 South<br>Allendale, NJ 07401<br>(201) 831-5612 (Phone)<br>(201) 831-6038 (FAX)                                                                                                                                                                                                                                                                                                                                                                     |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date:                  | September 17, 2003                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |
| Device:                | Scorpio <sup>®</sup> Knee System - Tibial Inserts                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| Classification:        | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-<br>constrained; Cemented prosthesis - Class II -21 CFR 888.3560                                                                                                                                                                                                                                                                                                                                                                                                                      |
| Predicate Devices:     | Scorpio <sup>®</sup> Knee System - Tibial Inserts                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
| Indications for Use:   | The Scorpio <sup>®</sup> Knee System tibial insert components are for use in<br>total knee arthroplasty for painful, disabling joint disease of the<br>knee resulting from degenerative arthritis, rheumatoid arthritis or<br>post-traumatic arthritis; post-traumatic loss of knee joint<br>configuration and function; moderate varus, valgus or flexion<br>deformity in with the ligamentous structures can be returned to<br>adequate function and stability; and/or revision of previous<br>unsuccessful knee replacement or other procedure. |
| Proposed Modification: | Redesign of the tibial insert component dimensions to provide for<br>improved hyperextension. In addition, to provide a claim for the<br>CR insert that indicates it provides sufficient constraint for use<br>when the posterior cruciate ligament (PCL) is absent or non-<br>functioning.                                                                                                                                                                                                                                                        |
| Device Description:    | The device includes the tibial insert components of a total knee<br>system. These components are used for the replacement of the<br>bearing surface of the proximal tibia to relieve pain, instability and<br>the restriction of motion due to degenerative bone disease,<br>including osteoarthritis, rheumatoid arthritis, failure of other<br>devices or trauma.                                                                                                                                                                                |
| Summary of Data:       | A risk analysis and Research and Development testing have been<br>performed to demonstrate equivalence of the proposed products to<br>the predicate devices. The testing includes range of constraint<br>testing, analysis of tibial insert post stress and contact stress/area<br>analysis. The results demonstrate equivalence.                                                                                                                                                                                                                  |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2004

Ms. Lorraine T. Montemurro Regulatory Affairs Manager Stryker Howmedica Osteonics 59 Route 17 South Allendale, New Jersey 07401

Re: K033342 Trade/Device Name: Scorpio® Knee System - Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, patellofemorotibial. polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: October 15, 2003 Received: October 17, 2003

Dear Ms. Montemurro:

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 adultcration.

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 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); labcling (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. Lorraine T. Montemurro

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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millerson

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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Konzade 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Scorpio® Knee System – Tibial Inserts

Indications for Use:

The Scorpio® Knec 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; .
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint;
- Absent or non-functioning posterior cruciate ligament. .

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">X</span> |                      |
|------------------|---------------------------------------------------|----------------------|
|                  | OR                                                | Over-the-Counter Use |
|                  | (Per 21 CFR 801.109)                              |                      |

for Mark N Millan

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K033342](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/JWH/K033342)

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