SCORPIO NRG KNEE SYSTEM

K042343 · Howmedica Osteonics Corp. · JWH · Feb 9, 2005 · Orthopedic

Device Facts

• Record ID: K042343
• Device Name: SCORPIO NRG KNEE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scorpio® NRG™ Knee System 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; revision of previous unsuccessful knee replacement or other procedure. Additional indications for posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; and/or an absent or non-functioning posterior cruciate ligament.

Device Story

Scorpio® NRG™ Knee System consists of femoral and tibial insert components for total knee arthroplasty. Designed to replace bearing/articulating surfaces of distal femur and proximal tibia. Used to relieve pain, instability, and restricted motion caused by degenerative bone disease, trauma, or previous implant failure. Operates as a semi-constrained, cemented prosthesis. Surgeons implant device in clinical setting to restore joint function and stability. Benefits include improved range of motion via redesigned component dimensions. Device is mechanical; no software or electronic components involved.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence supported by risk analysis, range of constraint testing, and finite element analysis (contact stress/area and femoral fatigue).

Technological Characteristics

Semi-constrained, cemented knee prosthesis. Materials: polymer/metal/polymer. Components: femoral and tibial inserts. Design features modified dimensions for increased range of motion. Sterilization and specific material standards not detailed in provided text.

Indications for Use

Indicated for patients undergoing 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; requires bone cement.

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® Total Knee
• Scorpio® Scorpio-flex™ Tibial Inserts
• Duracon A/P Lipped Tibial Inserts

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness – K042343

| 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) |
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| Date: | November 10, 2004 |
| Device: | Scorpio® NRG™ Knee System |
| Classification: | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-constrained; Cemented prosthesis - Class II -21 CFR 888.3560<br>Product Code: 87 JWH |
| Predicate Devices: | Scorpio® Total Knee<br>Scorpio® Scorpio-flex™ Tibial Inserts<br>Duracon A/P Lipped Tibial Inserts |
| Indications for Use: | The Scorpio® NRG™ Knee System 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; revision of previous unsuccessful knee replacement or other procedure. Additional indications for posterior stabilized components include: ligamentous instability requiring implant bearing surface geometries with increased constraint; and/or an absent or non-functioning posterior cruciate ligament. |
| Proposed Modification: | Redesign the femoral and tibial insert component dimensions to provide for increased range of motion. |
| Device Description: | The device includes femoral components and tibial insert components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or 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 range of constraint testing, finite element analysis of contact stress/area and finite element analysis of femoral fatigue. The results demonstrate equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

FEB - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042343

K042343
Trade/Device Name: Scorpio® NRG™ Knee System (Cruciate Retaining Components) Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH

Dated: January 18, 2005 Received: January 19, 2005

Dear Ms. Duchene:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave decembers of egally marketed predicate devices marketed in interstate for use statuu in the cholosure) to regally management date of the Medical Device Amendments, or to
r Commerce prior to May 28, 1976, the enactment date of the Medical Food D commence 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 Act (Act) that do not require approvise the general controls provisions of the Act. The You may, ulciclore, market the device, basjes, basic include registration, listing of general controls provisions of the 110 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 If your device is classified (500 a0070) ins existing major regulations affecting your device can may be subject to such additional behind of the 21, Parts 800 to 898. In addition, FDA may be found in the Ooue of I cants concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation or our device complies with other requirements of the Act that TDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations commitives but not limited to: registration and issting (21 Comply with an the Ace STequirements, and manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) I mo reteet notification. The FDA finding of substantial equivalence of your device to a legally premainer noticate 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 11 you attire 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,
Mark McMillan

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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## K042343

510(k) Number (if known): __

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Scorpio® NRG™ 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 .
- I out trainians rous 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 Devices:

- nial indivations 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.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________

AND/OR

Over-the-Counter Use_

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General. Restorative. and Neurological Devices

Number K047343