UNITED U2 BIPOLAR IMPLANT

K101670 · United Orthopedic Corp. · KWY · Oct 8, 2010 · Orthopedic

Device Facts

• Record ID: K101670
• Device Name: UNITED U2 BIPOLAR IMPLANT
• Applicant: United Orthopedic Corp.
• Product Code: KWY · Orthopedic
• Decision Date: Oct 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

U2 Bipolar Implant is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement 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 degenerative joint disease such as rheumatoid arthritis; correction of function deformity; revision procedures where other treatments or devices have failed; treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Story

U2 Bipolar Implant is a hemiarthroplasty device for hip replacement; consists of outer metal shell with permanently assembled bearing insert; features factory-assembled stopper ring and metal wire. Primary articulation occurs at femoral head/inner polyethylene bearing interface; secondary articulation at outer shell/acetabulum interface. Available in 41-73 mm outer diameters; compatible with 26mm, 28mm, or 36 mm femoral heads. Used by orthopedic surgeons in clinical settings for hip reconstruction. Device provides dual-mobility articulation to restore joint function and reduce wear. Highly polished outer metal surfaces articulate with patient's acetabulum.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included evaluation of locking mechanism integrity and range of motion.

Technological Characteristics

Bipolar endoprosthesis; metal/polymer construction. Features a locking ring mechanism for the polyethylene liner. Available in 41-73 mm outer diameters. Designed for use with 26mm, 28mm, or 36 mm femoral heads. Minimum polyethylene thickness of 5mm at load-bearing area. Highly polished outer metal shell.

Indications for Use

Indicated for skeletally mature patients requiring cemented or cementless hip replacement due to non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, painful hip dysplasia), inflammatory degenerative joint disease (rheumatoid arthritis), functional deformity, revision of failed treatments, or proximal femur fractures (nonunion, femoral neck, trochanteric) with head involvement.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.

Predicate Devices

• UNITED U1 Hip System – Bipolar (K050269)
• Wright GLADIATOR Bipolar System (K062693)

Submission Summary (Full Text)

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K101670

OCT - 8 2010

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: | Fang-Yuan Ho, |
| | Regulatory Affairs Manager |
| | Phone:[phone] ext. 212 |
| | Fax:[phone] |
| Date Prepared: | June 11, 2010 |

## Device Identification

| Device Name: | U2 Bipolar Implant |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bipolar endoprosthesis |
| Classification Name<br>and Reference : | Hip Joint femoral (Hemi-Hip) Metal/Polymer Cemented or<br>Uncemented Prosthesis per 21CFR 888.3390. This falls under<br>the Orthopedics panel. |
| Predicate Device: | 1. "UNITED" U1 Hip System – Bipolar (K050269)<br>2. "Wright" GLADIATOR Bipolar System (K062693) |

#### Device Description:

"UNITED" U2 Bipolar Implant, designed with a simple one-step assembly interface between femoral head and U2 Bipolar Implant, is a hemiarthroplasty design. U2 Bipolar Implant consists of an outer shell into which a bearing insert has been permanently assembled. The bearing insert has a factory assembled stopper ring and metal wire. The assembled prosthesis provides for primary articulation at the femoral

UOC-FDA-014

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# 0 U2 Bipolar Implant (K 101670)

head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner. The outer metal surfaces of the bipolar hip prosthesis are highly polished for articulation with the patient's acetabulum. Components are available in a range of sizes to fit varying anatomical requirements.

U2 Bipolar Implant are offered in 41-73 mm outer diameters and is designed to be used with either 26mm, 28mm, or 36 mm femoral heads, depending on the inner diameter liner. The minimum thickness of the polyethylene at its thinnest point at a load bearing area of the liner is at lest 5.mm in U2 Bipolar Implant.

### Intended Use

U2 Bipolar Implant is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement 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 degenerative joint disease such as rheumatoid arthritis; correction of function deformity; revision procedures where other treatments or devices have failed; treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

#### Basis for Substantial Equivalence:

The safety and effectiveness of U2 Bipolar Implant are substantially equivalent to the previously cleared U1 Hip System -- Bipolar (K050269), except for an extension in the size distribution and increasing stopper ring design. In addition, the subject device is also substantial equivalence to the "Wright" GLADIATOR Bipolar System (K062693).

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These two devices both use a locking ring mechanism.

## Performance Test - Bench:

The following tests were performed:

- 1. The integrity of locking mechanism
- Range of motion evaluation 2.

**UOC-FDA-014**

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Scrvice

OCT 0 8 2010

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

United Orthopedic Corporation % Ms. Fang-Yuan Ho 57 Park Ave Science Park Hsinchu, TW 300

Re: K101670

Trade/Device Name: U2 Bipolar Implant Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented Regulatory Class: Class II Product Code: KWY Dated: October 4, 2010 Received: October 7, 2010

Dear Ms. 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 Pederal 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, invince of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be nuth to book not midlers ing.

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 PDA'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: registroution and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of maniti device-rolated adverse events) (21 CFR 803); good manufacturing practice requirements as et

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Page 2 – Ms. Fang-Yuan Hol.

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 53)-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 the Courter for gover DA/CentersOffices/CDRH/CDRHOffices/ucm/15800, bttp://www.fov the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation ontitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDK regulation (2) 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 Small Manufacturers, International and Consumer Assistance at its tollillibe
1800) 638-2041 - 12011-7011 706-700 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcessforYou/Industry/default.htm.

Sincerely_yours.

Mark N. Melkerson

Director Division of Surgical, Orthopedic, and Restorative 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 Bipolar Implant

Indications for Use:

: 11 11 11

This device is intended for use in combination with UNITED Femoral System for comented or cementless hip replacement 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 degenerative joint disease such as theumatoid arthritis; correction of function deformity; revision procedures where other treatments or devices have failed; treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Prescription Use __x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

*Dand Kame for MXM*

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

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510(k) Number. K101670