MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT

K091069 · Medacta International S.A. · HWC · Jun 1, 2009 · Orthopedic

Device Facts

• Record ID: K091069
• Device Name: MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT
• Applicant: Medacta International S.A.
• Product Code: HWC · Orthopedic
• Decision Date: Jun 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System. The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - avascular necrosis of femoral condyle - post traumatic loss of joint configuration - primary implantation failure.

Device Story

Medacta Bone Screws provide supplemental fixation for tibial components of the Evolis Total Knee System. Screws are titanium alloy (Ti6-Al4-V); 6.5 mm thread diameter; available in 20-45 mm lengths. Used by orthopedic surgeons during total knee arthroplasty procedures in clinical settings. Screws are implanted into bone to secure the tibial component, enhancing stability in patients with sufficient bone stock. Benefit includes improved fixation of the knee prosthesis.

Clinical Evidence

Bench testing only. Conformance to ASTM F543-07 Standard Specification and Test Methods for Metallic Bone Screws was verified. No clinical data provided.

Technological Characteristics

Material: Titanium alloy (Ti6-Al4-V) per ISO 5832-3:1996. Thread diameter: 6.5 mm. Lengths: 20-45 mm (5 mm increments). Mechanical testing per ASTM F543-07. Non-sterile/sterile status not specified. No software or electronic components.

Indications for Use

Indicated for patients requiring total knee arthroplasty due to severe joint pain/disability from arthritis (traumatic, rheumatoid, polyarthritis), avascular necrosis of the femoral condyle, post-traumatic joint loss, or primary implantation failure, provided there is sufficient sound bone to support the Evolis Total Knee System components.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Plus Cancellous Bone Screws (K011719)
• Evolis Total Knee System (K081023)

Submission Summary (Full Text)

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K091069

Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of a stylized black triangle on the left, followed by the word "Medacta" in black sans-serif font. Below the word is a horizontal line, and below that is the word "International" in a smaller font, followed by a plus sign.

JUN - 1 2009

# Traditional 510(k) Summary

Manufacturer:

MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone [phone] FAX [phone]

Contact Person:

Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: [phone] Fax: [phone] email: [e-mail]

May 27, 2009 Date Prepared:

# DEVICE INFORMATION

| Trade/Proprietary Name: | Medacta Bone Screws |
|-------------------------|----------------------------------------------------------------------------------|
| Common Name: | Bone Screws |
| Classification Name: | Screw, Fixation, Bone<br>21 CFR 888.3560<br>Class II<br>Device Product Code: JWH |
| Predicate Devices: | K011719 Plus Cancellous Bone Screws<br>K081023 Evolis Total Knee System |

Product Description:

The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System. The Medacta Bone Screws have a thread diameter of 6.5 mm. The Medacta Bone Screws come in six lengths from 20 mm to 45 mm in increments of 5 mm.

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K091069

The Medacta Bone Screws are made of titanium alloy (Ti6-Al4-V) according to ISO5832-3:1996, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4-vanadium alloy.

#### Indications for Use:

The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System.

The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

- Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid arthritis or polyarthritis
- avascular necrosis of femoral condyle .
- post traumatic loss of joint configuration ●
- primary implantation failure. �

#### Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Druq and Cosmetic Act. Performance testing of the Medacta Bone Screws was conducted in accordance with international standards and FDA guidance documents. The bone screws were tested and found to be in conformance with ASTM F543-07 Standard Specification and Test Methods for Metallic Bone Screws.

#### Comparison with Predicate Device

The Medacta Bone Screws have the same indications for use and contraindications as the Evolis predicate device system with which they are intended to work. The Medacta Bone Screws are made of the same type of material as the Plus predicate device. They come in the same thread diameter as the Plus predicate and come in lengths within the range of the predicate device screw lengths.

#### Conclusion:

The data and information provided in this submission support the conclusion that the Medacta Bone Screws are substantially equivalent to its predicate devices. Plus Cancellous Bone Screws with respect to technological characteristics. The Medacta Bone Screws have the same indications for use as the Evolis Total Knee System with which they are intended to work. Actual device performance as tested conforms to applicable standards and FDA guidance.

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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 features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDACTA International SA % Ms. Natalie J. Kennel Consultant 13721 Via Tres Vista San Diego, California 92129

JUN - 1 2009

Re: K091069

Trade/Device Name: Medacta Bone Screws Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis

Regulatory Class: II Product Code: JWH, HWC Dated: May 29, 2009 Received: June 28, 2009

Dear Ms. Kennel:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Natalie J. Kennel

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely yours,

Oarbaro Buchet

Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K091069

# Indications for Use Statement

# 510(k) Number (if known): K091069

Device Name: Medacta Bone Screws

#### Indications for Use:

The Medacta Bone Screws are intended to provide additional bone fixation of the tibial components of the Evolis Total Knee System.

The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

- Severely painful and/or disabled joint as a result of arthritis, traumatic . arthritis, rheumatoid arthritis or polyarthritis
- avascular necrosis of femoral condyle .
- post traumatic loss of joint confiquration .
- primary implantation failure.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brimm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K091069