UNITED U2 PATELLA

K082469 · United Orthopedic Corp. · JWH · Sep 26, 2008 · Orthopedic

Device Facts

• Record ID: K082469
• Device Name: UNITED U2 PATELLA
• Applicant: United Orthopedic Corp.
• Product Code: JWH · Orthopedic
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The U2 Patella 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 indicated for cemented use only.

Device Story

U2 Patella is a semi-constrained total knee prosthesis component; machined from extruded UHMWPE bar. Features three-pegged design for fixation to host patella; includes cement groove for cemented use. Subject device adds 41 mm and 44 mm diameters to existing U2 Total Knee System (previously 26-38 mm). Used by orthopedic surgeons in clinical knee arthroplasty procedures. Device provides mechanical replacement of patellar surface to reduce pain and restore joint function. Performance verified via patellofemoral contact area and lateral stability testing.

Clinical Evidence

Bench testing only. Performance data included patellofemoral contact area and lateral stability testing to demonstrate substantial equivalence.

Technological Characteristics

Material: Extruded UHMWPE. Design: Three-pegged dome-shaped patellar component. Dimensions: 41 mm and 44 mm diameters (added to existing 26-38 mm range). Fixation: Cemented use only. Sensing/Energy: None (mechanical implant).

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, or posttraumatic joint loss. Applicable for patients with patellofemoral erosion, dysfunction, prior patellectomy, or moderate valgus/varus/flexion deformities. Also indicated for salvage of failed prior surgeries if knee can be balanced/stabilized. Cemented use only.

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)

Submission Summary (Full Text)

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K682169

#### g U2 Patella: Additional Size

510(k) Summary

# 510(k) Summary of Safety and Effectiveness

## Submission Information

| Company: | United Orthopedic Corporation | |
|-----------------|------------------------------------------------------|--|
| Address: | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan | |
| Contact Person: | Rudy Chen, | |
| | Regulatory Affairs | |
| | Phone:[phone] ext. 331 | |
| | Fax:[phone] | |
| Date Prepared: | August 25, 2008 | |

## Device Identification

| Device Name: | U2 Patella |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Semi-constrained total knee prostheses |
| Classification Name<br>and Reference : | Knee joint patellofemorotibial polymer/metal/polymer<br>semi-constrained cemented prosthesis per 21CFR 888.3560.<br>This falls under the Orthopedics panel. |
| Predicate Device: | "UNITED" U2 Total Knee system, manufactured by United<br>Orthopedic Corporation, K051640, cleared March 01, 2006 |

## Intended Use

The U2 Patella 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

UOC-FDA-010

Page: Summary-1/2

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#### മ്മ U2 Patella: Additional Size

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 indicated for cemented use only.

## Device Description:

The subject "UNITED" U2 Patella is identical to the legal on-market patellar components in the U2 Total Knee System (available in sizes 26, 29, 32, 35, and 38 mm), except for its larger diameter (available in sizes 41 and 44 mm). The patellar component is machined from extruded UHMWPE bar. It has a three-pegged design for fixation to the host patella and cement groove designed for cemented use only. The radius of dome for the patella components in U2 Patella and U2 Total Knee System are both 23.8 mm. The diameter and length of the pegs of these two systems are 5.0 mm and 4.5 mm, respectively.

### Statement of Technological Comparison

The materials for the subject and predicate devices are identical. The design of the subject and predicate device is the same, except that the subject device has larger size: 41 and 44 mm diameter. The performance testing is sufficient to demonstrate that the subject and predicate devices are substantially equivalent with regard to design. The modification does not change the intended use or fundamental scientific technology.

### Performance Data:

Performance testing, including patellofemoral contact area and lateral stability testing of the U2 Patella, completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.

### Public Health Service

SEP 2 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

United Orthopedic Corporation % Mr. Rudy Chen Regulatory Affairs, Manager No. 57, Park Avenue 2, Science Park, Hsinchu 300, Taiwan

Re: K082469 Trade/Device Name: U2 Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH Dated: August 25, 2008 Received: August 27, 2008

Dear Mr. Chen:

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, 7 rug 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 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 - Mr. Rudy Chen

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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Mark N. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

082469

510 (k) Number (if known):

Device Name: _U2 Patella

## Indications for Use:

This device 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 patcllectorny, 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 system is designed for cemented use only.

| Prescription Use | x |
|------------------|---|
| AND/OR | |

ver-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)

Occurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off Division of General, Restorative. and Neurological Devi

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**510(k) Number**