U2 FEMORAL COMPONENT, CR, POROUS COATED

K140075 · United Orthopedic Corp. · MBH · Jun 13, 2014 · Orthopedic

Device Facts

• Record ID: K140075
• Device Name: U2 FEMORAL COMPONENT, CR, POROUS COATED
• Applicant: United Orthopedic Corp.
• Product Code: MBH · Orthopedic
• Decision Date: Jun 13, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery. For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only. For porous coated femoral component: This device is a single use implant and intended for cementless use only.

Device Story

U2 Femoral Component is a porous-coated, uncemented knee prosthesis component. It serves as a replacement for the femoral condyle in total knee arthroplasty. The device is manufactured from Co-Cr-Mo alloy; the inner surface features Co-Cr-Mo beads for porous coating to facilitate biological fixation. It is available in seven sizes (#1-#7) and left/right configurations. The device is implanted by an orthopedic surgeon during knee replacement surgery. It functions as a mechanical load-bearing implant to restore joint configuration and function. The device is intended for cementless use. It provides a stable articulating surface for the knee joint, aiming to reduce pain and improve mobility in patients with severe joint degeneration.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including range of motion, contact area and pressure on femorotibial and femoropatellar joints, subluxation testing, and fatigue compression testing of the femoral component.

Technological Characteristics

Material: Co-Cr-Mo alloy (ASTM F75). Design: Porous-coated femoral component for cementless fixation. Dimensions: Seven sizes (#1-#7), AP/ML 52-76mm/80mm. Configuration: Left and right. Energy source: None (mechanical implant). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring knee arthroplasty for pain relief or improved function due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, pseudogout, posttraumatic joint loss, or failed prior surgical attempts.

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

• United U2 Total Knee System (K051640)
• Smith & Nephew Genesis II Total Knee System (K030612)

Submission Summary (Full Text)

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JUN 1 3 2014

#### 0 U2 Femoral Component, CR, Porous Coated

510(k) Summary

### 510(k) Summary of Safety and Effectiveness

| Submitter Information | |
|-------------------------|----------------------------------------------------------------------------------------------------------|
| Name | United Orthopedic Corporation |
| Address | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan |
| Phone Number | [phone] ext. 2212 |
| Fax Number | [phone] |
| Name of Contact Person | Fang-Yuan Ho |
| | Regulation and Document Management |
| Date prepared | January 10, 2014 |
| Name of Device | |
| Trade Name | U2 Femoral Component, CR, Porous Coated |
| Common Name | Femoral Component |
| Classification Name and | Knee joint patellofemorotibial metal/polymer |
| Regulation | porous-coated uncemented prosthesis under 21CFR §<br>888.3565 |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | MBH |
| Predicate Device | 1. “United” U2 Total Knee System (K051640)<br>2. “Smith & Nephew” Genesis II Total Knee System (K030612) |

#### Device Description:

U2 Porous Coated Femoral Component-CR Type is manufactured from Co-Cr-Mo alloy confirming to ASTM F75. The inner surface is porous coated with Co-Cr-Mo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of

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#### U2 Femoral Component, CR, Porous Coated

cleared U2 Total Knee System (K051640), except adding size #7.

#### Intended Use:

The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

#### Comparison to Predicate Device:

U2 Porous Coated Femoral Component-CR Type has the same materials, design, manufacturing and sterilization method as the femoral component of "United" U2 Total Knee System (K051640), except adding size #7. Besides, the basic design, size distribution, intended use of the subjected device and the method of fixation are similar with the femoral component of "Smith & Nephew" Genesis II Total Knee System (K030612).

#### Performance Data:

#### · Non-clinical Performance

This 510(k) submission was prepared in accordance with the Agency's. " Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and

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# ( U2 Femoral Component, CR, Porous Coated

#### 510(k) Summary

Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA". Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective.

- Range of Motion a.
- · b. Contact Area and Contact Pressure on Femorotibial Joint
- Contact Area and Contact Pressure on Femoropatellar Joint C.
- d. Subluxation of Femoroltibial Joint
- Fatigue Compression Test of Femoral Component e.
- Clinical Performance Data/Information

None provided as a basis for substantial equivalence.

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Image /page/3/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a human figure with outstretched arms, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 13, 2014

United Orthopedic Corporation Fang-Yuan Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu 300 Taiwan

K140075 Re:

Trade/Device Name: U2 Femoral Component, CR, Porous Coated Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH Dated: March 24, 2014 Received: March 25, 2014

Dear Fang-Yuan Ho,

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

... . ...

Sincerely vours.

## Lori A. Wiggins

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indication for Use

510 (k) Number (if known): K140075

Device Name: U2 Femoral Component, CR, Porous Coated

### Indications for Use:

The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L Hanley, Ph, D. Division of Orthopedie Devices

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