U2 ACETABULAR COMPONENT

K050262 · United Orthopedic Corp. · LWJ · Aug 15, 2005 · Orthopedic

Device Facts

• Record ID: K050262
• Device Name: U2 ACETABULAR COMPONENT
• Applicant: United Orthopedic Corp.
• Product Code: LWJ · Orthopedic
• Decision Date: Aug 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The U2 Acetabular Component is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia; - Inflammatory degenerative joint disease such as rheumatoid arthritis, 2. - Correction of function deformity, 3. - Revision procedures where other treatments or devices have failed; and 4. - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur เก with head involvement that is unmanageable using other techniques. The U2 Acetabular Component is designed for uncemented application and is single use only.

Device Story

Modular acetabular component for total hip replacement; used with United U1/U2 hip stems. Hemispherical metallic shell (forged Titanium alloy) with Ti plasma spray or HA/Ti plasma spray coating; UHMWPE liner. Optional Titanium cancellous bone screws for fixation. Implanted by orthopedic surgeons in clinical/hospital settings. Provides stable acetabular surface to restore hip function and reduce pain. Single-use, uncemented application.

Clinical Evidence

Bench testing only. Mechanical testing performed to evaluate static tensile and shear strengths of HA/Ti plasma spray coatings, and push-out, lever-out, and torque-out performance of the liner-cup locking mechanism.

Technological Characteristics

Hemispherical shell: forged Titanium alloy (ASTM F620). Liner: extruded UHMWPE (ISO 5834/1). Optional screws: Titanium (ASTM F136). Coatings: Ti plasma spray or HA/Ti plasma spray. Uncemented application. Modular design with 14 sizes.

Indications for Use

Indicated for skeletally mature patients requiring hip pain relief or improved function due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, revision procedures, or proximal femur fractures (nonunion, femoral neck, trochanteric) with head involvement.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

Predicate Devices

• UNITED U1 Hip Prosthesis (K994078)
• Howmedica Osteonics Trident® Hemispherical acetabular shells (AD and AD-HA) (K013676)
• Howmedica Osteonics Trident® Porous Titanium Acetabular Component (K010170)

Reference Devices

• U2 hip stem (K003237)

Submission Summary (Full Text)

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K050262

#### 9 U2 Acetabular Component

Summary

# 510(k) Summary of Safety and Effectiveness

| Submitted By: | United Orthopedic Corporation<br>No. 57, Park Ave. 2, Science Park, Hsinchu, 300, Taiwan<br>Tel: [phone]<br>Fax: [phone] |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | January 14th, 2005 |
| Contact person | Gene Huang / Regulatory Affairs |
| Device Name: | U2 Acetabular Component |
| Common Name: | Acetabular Component |
| Classification Name and<br>Reference: | 21CFR 888.3360 Hip Joint femoral (hemi-hip) metallic<br>cemented or uncemented prosthesis. |
| Predicate Device: | UNITED U1 Hip Prosthesis (K994078)<br>Howmedica Osteonics Trident® Hemispherical acetabular<br>shells (AD and AD-HA) (K013676)<br>Howmedica Osteonics Trident® Porous Titanium Acetabular<br>Component (K010170) |

### Device Description:

The U2 Acetabular Component is designated to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Component has 14 sizes, hemispherical design and without or with clustered bone screw holes for variable screw locking angle. The metallic shell is manufactured from forged Titanium alloy (ASTM F620) and its outer surface has two types of coating. Ti plasma spray and IIA/Ti plasma spray. The acetabular liner is machined from extruded UHMWPE bars (ISO 5834/1) and its minimum thickness is 4 18 mm to reduce contact stress. If supplemental bone screw fixation is deemed necessary, Titanium Cancellous Bone Screws (ASTM F136) can be inserted through the screw holes without interfering with the seating of the acetabular liner.

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#### 9 U2 Acetabular Component

### Intended Use:

The U2 Acetabular Component is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis, 2.
- Correction of function deformity, 3.
- Revision procedures where other treatments or devices have failed; and 4.
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur เก with head involvement that is unmanageable using other techniques.

The U2 Acetabular Component is designed for uncemented application and is single use only.

#### Mechanical test data:

The static tensile and shear strengths of HA/Ti plasma spray and the push-out, lever-out and torque-out test data for the liner-cup locking mechanism indicated that U2 Acetabular Component is substantial equivalent to the predicate devices.

## Substantial Equivalence Information:

The design concept, material composition, HA coating and locking mechanism of U2 Acetabular Component are similar with currently marketed predicate devices. The U2 Acetabular Component is substantial equivalent to the predicate devices, UNITED UI Hip system (K994078) and Howmedica Osteonics Trident® Hemispherical acetabular shells (AD and AD-HA) (K013676).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a stylized graphic of a human figure. The graphic is composed of three curved lines that form the silhouette of a person's head and shoulders. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Public Health Service

AUG 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gene Huang Manager Regulatory Affairs United Orthopedic Corporation _ . No. 57, Park Avenue 2, Science Park Hsinchu China (Taiwan) 300

Re: K050262

Trade/Device Name: U2 Acetabular Component Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II

Product Code: LWJ, MEH Dated: July 12, 2005 Received: July 15, 2005

Dear Mr. Huang:

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 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. Gene Huang

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you've organization of substantial equivalence of your device to a legally prematics notification "The 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 If you desire of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronal 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,

Mark Williamson

Mark N. Melkerson Acting 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): ___K050262

Device Name: _U2 Acetabular Component r

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Indications for Use:

This device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

- · Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
- · Inflammatory degencrative joint disease such as rheumatoid arthritis;
- Correction of function deformity; .
- Revision procedures where other treatments or devices have failed; and .
- Treatment of nonunion, femoral neck, and trochanteric fractures of the ● proximal femur with head involvement that are unmanageable using other techniques.

The U2 Acetabular Components are designed for uncemented application and single use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*ivision Sign-Off)
Division of General, Restorative
nd Neurological Devices

Number K050262

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