BIOPRO POLAR HEAD

K100761 · Biopro, Inc. · KWY · Dec 3, 2010 · Orthopedic

Device Facts

• Record ID: K100761
• Device Name: BIOPRO POLAR HEAD
• Applicant: Biopro, Inc.
• Product Code: KWY · Orthopedic
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BioPro Bipolar Head is intended for use in combination with a BioPro PSL femoral stem for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: • Femoral neck and trochanteric fractures of the proximal femur • Osteonecrosis of the femoral head • Revision procedures where other devices or treatments for this indications have failed

Device Story

Bipolar hip prosthesis for hemiarthroplasty; used with BioPro PSL femoral stem. Components: cobalt chrome outer shell, UHMWPE liner, UHMWPE retention ring, Ti-6Al-4V spring. Outer diameters 38-60mm; inner diameters mate with 22mm or 28mm femoral heads. Device replaces femoral head to restore hip joint function. Implanted by orthopedic surgeons in clinical/OR settings. Provides articulation for patients with femoral fractures or osteonecrosis; improves mobility and reduces pain by replacing damaged femoral head surface.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is based on bench testing, including push-out and lever-out strength testing and heat tolerance testing of the locking ring spring.

Technological Characteristics

Materials: Cobalt chrome shell, UHMWPE liner (ASTM F-648), Ti-6Al-4V Eli spring. Dimensions: 38-60mm outer diameter. Sterilization: ETO. Mechanical design: Bipolar head with interference-fit retaining ring and spring mechanism. No software or electronics.

Indications for Use

Indicated for primary or revision hip hemiarthroplasty in patients with femoral neck/trochanteric fractures, osteonecrosis of the femoral head, or failed prior treatments.

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

• BioPro Bipolar Head (K082705)
• K082468
• K945793
• K931655
• K100151

Submission Summary (Full Text)

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## 510K Summary K100761

.

| Submitter | BioPro, Inc.<br>2929 Lapeer Rd<br>Port Huron, MI | Contact | David Mrak<br>Director of Product Development<br>810-982-7777 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------------|
| Preparation Date: | August 23, 2010 | | DEC - 3 2010 |
| Device Name | | | |
| Common Name | Hemi-Hip prosthesis, uncemented | | |
| Trade Name | BioPro Bipolar Head | | |
| Classification Name | Hip joint femoral (hemi-hip) metal/polymer cemented<br>or uncemented prosthesis orthopedic (OR) | | |
| Regulatory Class | Class II per 21CFR 888.3390 | | |
| Product Code | KWY | | |
| Legally Marketed<br>Predicate Device(s) | K082705 (BioPro Bipolar Head)<br>K082468, K945793, K931655, K100151 | | |
| Device Description | The BioPro Bipolar Head consist of a factory assembled Ultra High<br>Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome<br>outer shell and UHMWPE retention ring with a Ti-6Al-4v spring. These<br>bipolar heads include outer diameters ranging from 38-60mm, in 1mm<br>increments, to properly fit the patient anatomy. The smaller bipolar<br>heads (38-42 mm) have an inner diameter that mates with a 22mm<br>diameter femoral head; the larger bipolar heads (43-60mm) have an<br>inner diameter that mates with a 28mm diameter femoral head. The<br>BioPro Bipolar Head may be used in conjunction with a BioPro PSL<br>femoral stem (K872535 and K871462) for hemiarthroplasty. | | |
| Indications for Use | The indications have not changed from the predicate. The BioPro<br>Bipolar head is intended for use in combination with the BioPro PSL<br>femoral stem for primary or revision hemiarthroplasty of the hip. This<br>prosthesis may be used for the following conditions, as appropriate:<br>• Femoral neck and trochanteric fractures of the proximal femur<br>• Osteonecrosis of the femoral head<br>• Revision procedures where other devices or treatments for this<br>indications have failed | | |
| Predicate Device<br>comparison | The BioPro Bipolar Head is identical to the BioPro Bipolar head cleared<br>in K082705 with the following exceptions:<br>• The UHMWPE (ASTM F-648) retaining ring in the acetabular<br>component was modified to increase the amount of<br>interference/overlap between the retaining ring and the head | | |

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- A retaining Spring (Ti-6Al-4V Eli) was added to the UHMWPE . retaining ring.
Technological Characteristics

Non-Clinical Test Summary ...

The device is identical to the Omni Life Science Bipolar head 510k 100151 and is manufactured to the same standards and technical drawings

The following tests were conducted:

- . Push-out and lever out testing. Push-out and lever out strengths were within the range of legally marketed bipolar designs.
- Locking ring spring storage heat tolerance test (150 deg. F) .
- ETO sterilization validation 10°6 ●

Clinical Test Summary

No Clinical studies were performed

Conclusions

The BioPro Bipolar head is a substantially equivalent device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

DEC 0 3 2010

BioPro Inc. % Mr. David Mrak Director of Product Development 2929 Lapeer Road Port Huron, Michigan 48060

Re: K100761 Trade/Device Name: BioPro Bipolar Heads Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY Dated: September 28, 2010 Received: September 29, 2010

Dear Mr. Mrak:

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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Page 2 – Mr. David Mrak

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark McMullen

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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## Indications for Use

510(k) Number (if known): K100761

Device Name: BioPro Bipolar Head

Indications for Use:

The BioPro Bipolar Head is intended for use in combination with a BioPro PSL femoral stem for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

- Femoral neck and trochanteric fractures of the proximal femur; .
- Osteonecrosis of the femoral head: .
- Revision procedures where other devices or treatments for these . indications have failed.

Prescription Use X (Per 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)

Omitu for nxn
(Division Sign Off)

(Division Sign-G Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K100761