SCORPIO NRG KNEE SYSTEM

K030978 · Howmedica Osteonics Corp. · JWH · Nov 20, 2003 · Orthopedic

Device Facts

• Record ID: K030978
• Device Name: SCORPIO NRG KNEE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Nov 20, 2003
• 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; and/or 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; 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; replaces bearing/articulating surfaces of distal femur and proximal tibia. Designed to relieve pain, instability, and motion restriction caused by degenerative bone disease, trauma, or previous device failure. Redesigned component dimensions provide increased range of motion compared to predicate Scorpio® systems. Intended for single-use implantation with bone cement by surgeons in clinical settings. Benefits include restored joint function and stability.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence demonstrated via risk analysis and R&D testing including range of motion, tibial insert post stress, and contact stress/area analysis.

Technological Characteristics

Total knee arthroplasty system; semi-constrained, cemented prosthesis. Materials: polymer/metal/polymer. Components: femoral and tibial inserts. Design features: modified dimensions for increased range of motion.

Indications for Use

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

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

Submission Summary (Full Text)

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## NOV 2 0 2003

## 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>[phone] (Phone)<br>[phone] (FAX) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | February 14, 2003 |
| Device: | Scorpio® NRG™ Knee |
| Classification: | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-<br>constrained; Cemented prosthesis - Class II -21 CFR 888.3560 |
| Predicate Devices: | Scorpio® Total Knee<br>Scorpio® Scorpio-flex™ Tibial Inserts |
| Indications for Use: | The Scorpio® NRG™ Knee System components are for use in total<br>knee arthroplasty for 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 with<br>the ligamentous structures can be returned to adequate function<br>and stability; and/or revision of previous unsuccessful knee<br>replacement or other procedure. |
| | Additional indications for the Posterior stabilized components<br>include:<br>Ligamentous instability requiring implant bearing surface<br>geometries with increased constraint; and/or an absent or non-<br>functioning posterior cruciate ligament. |
| Proposed Modification: | Redesign the femoral and tibial insert component dimensions to<br>provide for increased range of motion. |
| Device Description: | The device includes femoral components and tibial insert<br>components of a total knee system. These components are used for<br>the replacement of the bearing and/or articulating surfaces of the<br>distal femur, proximal tibia 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 range of constrained testing, analysis of tibial insert post stress and contact stress/area analysis. The results demonstrate equivalence.

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NOV 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Denise Duchene Sr. Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401

Re: K030978

·

Trade/Device Name: Scorpio NRG Knee System Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II

Product Codes: JWH Dated: August 21, 2003 Received: August 22, 2003

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 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.

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

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Page 2 - Ms. Denise Duchene

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), 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] (vr [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celua 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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510(k) Number (if known):
K030978

Device Name: Scorpio® NRG™ Knee System Components

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

Division Sign Off

(Division Sign-Off) Division of General, Restorative and Neurological Devices

(PLEASE DO NOT WRITE BELOW THIS LINE GE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use OR (Per 21 CFR 801.109)