U2 Total Knee System- Additional Sizes

K150829 · United Orthopedic Corporation · JWH · Sep 25, 2015 · Orthopedic

Device Facts

• Record ID: K150829
• Device Name: U2 Total Knee System- Additional Sizes
• Applicant: United Orthopedic Corporation
• Product Code: JWH · Orthopedic
• Decision Date: Sep 25, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• 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 can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cemented use only.

Device Story

The U2 Total Knee System is a size extension of a previously cleared knee prosthesis. It consists of femoral components and tibial inserts (including XPE and ultracongruent options) used in total knee arthroplasty. The device is implanted by an orthopedic surgeon in a clinical setting to replace damaged joint surfaces. It functions as a semi-constrained cemented prosthesis to restore joint mechanics, reduce pain, and improve function. The device is a single-use implant. Clinical benefit is derived from the restoration of knee joint configuration and stability in patients with severe arthritis or joint deformity.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on non-clinical bench testing, including range of motion, contact area/pressure (femorotibial and femoropatellar), joint constraint, fatigue compression of the femoral component, locking strength of the tibial insert, fatigue performance of the tibial insert spine, and material properties of the XPE tibial insert.

Technological Characteristics

Semi-constrained cemented knee prosthesis. Materials are identical to predicate U2 system (metal/polymer). Components include femoral component, tibial insert, XPE tibial insert, and ultracongruent insert. Design is a size extension of existing cleared system. Sterilization and manufacturing methods remain unchanged.

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 deformities (valgus, varus, flexion). Also indicated for salvage of failed surgical attempts if knee can be balanced/stabilized. Contraindications: not specified beyond requirement for skeletal maturity and cemented use.

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

• UNITED U2 Total Knee System (K051640)
• UNITED U2 XPE Total Knee System (K103733)
• UNITED U2 Femoral Component, PS, #7 (K120507)
• UNITED Tibial inserts, #7 (K131864)
• UNITED Ultracongruent Insert (K132752)
• UNITED U2 Femoral Component, CR, Cemented (K140073)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.

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

September 25, 2015

United Orthopedic Corporation Fang-Yuan Ho Regulatory Affairs Manager Number 57, Park Avenue 2, Science Park Hsinchu 300 Taiwan

Re: K150829 Trade/Device Name: U2 Total Knee System-Additional Sizes Regulation Number: 21 CFR 888.3650 Regulation Name: Knee joint patellofemorobial polymer/metal semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 20, 2015 Received: March 30, 2015

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

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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.

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/Resourcesfor You/Industry/default.htm. 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 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 yours,

## Mark N. Melkerson -S

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):

### Device Name: U2 Total Knee System-Additional Sizes

### 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 can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cemented use only.

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ 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)

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# ೪ U2 Total Knee System—Additional Sizes

### 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<br>Regulation and Document Management |
| Date prepared | March 20, 2015 |
| Name of Device | |
| Trade Name | U2 Total Knee System—Additional Sizes |
| Common Name | Total Knee Prosthesis |
| Classification Name and<br>Regulation | Knee joint patellofemorotibial polymer/metal/polymer<br>semi-constrained cemented prosthesis under 21CFR §888.<br>3560 |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | JWH |
| Predicate Device | 1. “UNITED” U2 Total Knee System (K051640)<br>2. “UNITED” U2 XPE Total Knee System (K103733)<br>3. “UNITED” U2 Femoral Component, PS, #7 (K120507)<br>4. “UNITED” Tibial inserts, #7 (K131864)<br>5. “UNITED” Ultracongruent Insert (K132752)<br>6. “UNITED” U2 Femoral Component, CR, Cemented (K140073) |

### Device Description:

This subjected device includes femoral component, tibial insert, XPE tibial insert and

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### 0 U2 Total Knee System-Additional Sizes

510(k) Summary

ultracongruent insert. It is a size extension to the cleared "UNITED" U2 Total Knee System (K051640, K120507, K131864, K103733, K132752, and K140073). The indications, materials, design of this subject device are identical to the cleared "UNITED" U2 Total Knee System except for its dimension.

#### 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 can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cemented use only.

### Comparison to Predicate Device:

U2 Total Knee System, Additional Sizes has the same basic design, intended use, materials and the same manufacturing method as device of the "United" U2 Total Knee System (K051640, K120507, K131864, K103733, K132752 and K140073). The only difference between the cleared and subjected device is dimension.

### 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 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.

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#### g U2 Total Knee System—Additional Sizes

- Range of Motion a.
- Contact Area and Contact Pressure on Femorotibial Joint b.
- Contact Area and Contact Pressure on Femoropatellar Joint c.
- Constraint of Femoroltibial Joint d.
- Fatigue Compression Test of Femoral Component e.
- Locking Strength of Tibial Insert f.
- Fatigue Performance of Tibial Insert Spine g.
- Materials Properties of U2 XPE Tibial Insert h.

### ● Clinical Performance Data/Information

None provided as a basis for substantial equivalence.