BIOPRO BIPOLAR HEAD, MODELS 18130-18152

K082705 · Biopro, Inc. · KWY · Dec 15, 2008 · Orthopedic

Device Facts

• Record ID: K082705
• Device Name: BIOPRO BIPOLAR HEAD, MODELS 18130-18152
• Applicant: Biopro, Inc.
• Product Code: KWY · Orthopedic
• Decision Date: Dec 15, 2008
• 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 Hip System femoral stem for uncemented primary or revision arthroplasty 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.

Device Story

BioPro Bipolar Head is a hip prosthesis component for uncemented primary or revision arthroplasty. Device consists of a cobalt chrome outer shell, UHMWPE liner, and UHMWPE retention ring. It functions as a self-aligning bipolar head, mating with a femoral stem. Used by orthopedic surgeons in clinical settings. The device provides a bearing surface for hip joint movement, replacing the femoral head to restore joint function and mobility in patients with fractures or osteonecrosis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Outer shell: Cobalt chromium (ASTM F75). Liner/retention ring: UHMWPE (ASTM F648). Sterilization: EtO. Design: Bipolar, self-aligning, eccentric head. Dimensions: 38-60 mm outer diameter (1 mm increments). Assembly: Snap-fit liner with retention ring. No software or electronic components.

Indications for Use

Indicated for patients requiring primary or revision hip arthroplasty due to femoral neck/trochanteric fractures or osteonecrosis of the femoral head, where other treatments have failed.

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

• Pivot Bipolar Femoral Head (K050966)
• PLUS Bipolar Prosthesis (K982447)

Submission Summary (Full Text)

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# KOB2705 (pg1/2)

## 510K Summary

DEC 1 5 2008

## BioPro Bipolar Head

## August 25, 2008

BioPro, Inc. 17 17th Street Port Huron, MI 48060

Contact: David Mrak Director of Product Dev. [phone]

### 2. Device Name

1. Submitter:

BioPro Bipolar Head Proprietary Name: Hip prosthesis, uncemented Common Name: Hip joint femoral metal/polymer cemented or uncemented Classification Name: prosthesis Class II per 21 CFR §888.3390 Requlatory Class:

### 3. Intended Use

The BioPro Bipolar Head is intended for use in combination with a BioPro femoral stem for uncemented primary or revision arthroplasty 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.

### 4. Device Description

The BioPro Bipolar Head consists of a factory assembled UHMWPE liner in a cobalt chrome outer shell, and UHMWPE retention ring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have with a == iiim ater that mates with a 28 mm diameter femoral head. The BioPro Bipolar an infor diamotor that may be a BioPro femoral stem (K882146) for arthroplasty.

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## 5. Predicate Device Comparison

Substantial equivalence is claimed to the Pivot Bipolar Femoral Head (1882146) Substantial equivalorio is claimot to the PLUS Bipolar Prosthesis (K982447) distributed by Ortho Dovelopment and Smith & Nephew). The following table distributed by Tus Orthopadules (non-Shiken the BioPro Bipolar Head and these predicate devices:

| | BioProBipolar<br>Head | Ortho<br>Development Pivot<br>Bipolar Head | Plus Orthopedics<br>PLUS Bipolar<br>Prosthesis |
|-----------------------------------|----------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(k) Number | Pending | K050966 | K982447 |
| FDA Product Code | KWY | KWY | KWY |
| DESIGN | | | |
| Head-Liner-Shell | CoCr-UHMWPE-<br>CoCr | CoCr-UHMWPE-<br>CoCr | CoCr-UHMWPE-<br>CoCr |
| Head Outer<br>Diameter | 38 to 60 mm in<br>1 mm increments | 38 to 60 mm in<br>1 mm increments | 43 to 60 mm in<br>1 mm increments |
| Self-aligning<br>(eccentric head) | Yes | Yes | Yes |
| Liner Inner Diameter | 22.225 or 28 mm | 22.225 or 28 mm | 28 mm |
| Liner-Head<br>Assembly | Head snap-fit into<br>bipolar liner | Head snap-fit into<br>bipolar liner | Head held in by<br>retention ring |
| UHMWPE retention<br>ring | Yes | Yes | Yes |
| MATERIALS | | | |
| Outer shell | Cobalt chromium<br>(ASTM F75) | Cobalt chromium<br>(ASTM F75) | Cobalt chromium<br>(ASTM F75) |
| Liner and retention<br>ring | UHMWPE (ASTM<br>F648), EtO<br>sterilized (not<br>highly crosslinked) | UHMWPE (ASTM<br>F648), gamma<br>sterilized (not highly<br>crosslinked) | UHMWPE (ASTM<br>F648), EtO<br>sterilized (not<br>highly crosslinked) |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

#### Public Health Service

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

BioPro, Inc. % Mr. David Mrak Director of Product Development 17 Seventeenth St. Port Huron, Michigan 48060

## DEC 1 5 2008

Re: K082705

Trade/Device Name: BioPro Bipolar Head, Models 18130 - 18152 Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis

Regulatory Class: II Product Code: KWY Dated: August 15, 2008 Received: September 16, 2008

Dear Mr. Mrak:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed for we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 to sund in the encreation of the enactment date of the Medical Device Amendments, or to Conninered phor to May 20, 1976, Lie accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Free) that to her ice, subject to the general controls provisions of the Act. The r ou may, ulciclore, thanker and act include requirements for annual registration, listing of general controls provisions of the rise, 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 If your device is classified the world . Existing major regulations affecting your device can thay be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Court of I courts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDF is issualles or on device complies with other requirements of the Act that TDA has made a determinations administered by other Federal agencies. You must of any I cucha statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Fart 807), idocimig (21 CFR Part 820); and if applicable, the electronic for the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. David Mrak

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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millman

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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# Indications for Use

KD827056pg1/1) 510(k) Number (if known):

Device Name: BioPro Bipolar Head

Indications for Use:

The BioPro Bipolar Head is intended for use in combination with a BioPro PSL Hip System femoral stem for uncemented primary or revision arthroplasty 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)

Niel R.P. Oden for

Page 1 of

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

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