3DKNEE POROUS COATED FEMORAL COMPONENT

K032905 · Encore Orthopedics, Inc. · MBH · Jul 6, 2004 · Orthopedic

Device Facts

• Record ID: K032905
• Device Name: 3DKNEE POROUS COATED FEMORAL COMPONENT
• Applicant: Encore Orthopedics, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Jul 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function. This device is for uncemented use only.

Device Story

3DKnee™ Porous Coated Femoral Component; orthopedic implant for total knee replacement. Manufactured from CoCr alloy; features porous CoCrMo bead coating for uncemented fixation. Available in 7 sizes; left/right configurations. Designed to match tibial insert condyles for congruency. Used by orthopedic surgeons in clinical settings for primary or revision arthroplasty. Relieves knee pain; restores joint function. Implanted via surgical procedure.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate device.

Technological Characteristics

Material: CoCr alloy (ASTM F75). Surface: Porous CoCrMo beads (ASTM F75). Configuration: 7 sizes (2-12), left/right. Fixation: Uncemented. Design: Femoral component matching tibial insert condyles.

Indications for Use

Indicated for patients requiring primary or revision total knee arthroplasty with minimal bone loss and intact collateral ligaments. Conditions include noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis), avascular necrosis of femoral condyle, post-traumatic joint loss (patellofemoral erosion/dysfunction/prior patellectomy), moderate valgus/varus/flexion deformities, rheumatoid arthritis, and fractures unmanageable by other techniques.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• 3DKnee™ (K020114)

Submission Summary (Full Text)

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# Summary of Safety and Effectiveness

K032905
Page 1 of 1

Encore Medical, L.P. 9800 Metric Blvd Austin, TX 78758 512-834-6237

Trade Name: 3DKnee™ Porous Coated Femoral Component

Common Name: Porous Coated Femoral Component

Classification Name: Knee joint patellofemoraotibial metal/polymer porous coated uncemented prosthesis per 21 CFR888.3565.

# Indications:

This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function. This device is for uncemented use only.

# Description:

The 3DKnee™ porous coated femoral component is manufactured from CoCr alloy conforming to ASTM F75. The inner surface is porous coated with CoCrMo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in 7 sizes (2-12) and is provided in left and right configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is the same design as the 3DKnee™ cleared in K020114.

# Substantial Equivalence

The 3DKnee™ porous femoral component is similar in design, materials and indications to the 3DKnee™ (K020114).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 2004

Ms. Debbie De Los Santos Supervisor, Regulatory/Clinical Services Encore Medical, L.P. 9800 Metric Boulevard Austin, Texas 78758

Re: K032905

Trade/Device Name: 3DKnee Porous Coated Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: September 12, 2003 Received: September 22, 2003

Dear Ms. De Los Santos:

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 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

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Page 2 – Ms. Debbie De Los Santos

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" (21 CFR 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,

for Miriam C. Provost

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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510(k) Number (if known):

Device Name: 3DKnee™ Porous Coated Femoral Component

Indications For Use:

# 3DKnee™ Porous Coated Femoral Component Indications For Use

This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.

- Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis ●
- Avascular necrosis of the femoral condyle 체
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral 피 erosion, dysfunction or prior patellectomy
- 1 Moderate valgus, varus or flexion deformities
- 제 Rheumatoid arthritis
- Treatment of fractures that are unmanageable using other techniques. 트

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

Miriam C. Provost

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

**510(k) Number** K032905

Concurrence of CDRH, Office of Device Evaluation (ODE)

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OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)