APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)

K100151 · Omnlife Science · KWY · May 28, 2010 · Orthopedic

Device Facts

• Record ID: K100151
• Device Name: APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)
• Applicant: Omnlife Science
• Product Code: KWY · Orthopedic
• Decision Date: May 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented 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.

Device Story

Apex Hip System Bipolar Head is a hemi-hip prosthesis for uncemented primary or revision hemiarthroplasty. Device consists of a factory-assembled UHMWPE liner within a cobalt chrome outer shell, a UHMWPE retention ring, and a Ti-6Al-4V spring. Outer diameters range from 38 to 60 mm; inner diameters mate with 22 mm or 28 mm femoral heads. Used in conjunction with Apex Hip System femoral stem. Operated by orthopedic surgeons in clinical/surgical settings. Device functions as a prosthetic replacement for the femoral head to restore hip joint function in patients with fractures or osteonecrosis. Output is a mechanical articulation surface for the hip joint, aiding patient mobility and pain relief.

Clinical Evidence

No clinical data. Bench testing only, including push-out and lever-out mechanical testing and heat tolerance testing for the locking ring spring.

Technological Characteristics

Materials: UHMWPE (ASTM F-648), Cobalt Chrome, Ti-6Al-4V Eli. Bipolar head design with factory-assembled liner and retention ring. Dimensions: 38-60 mm outer diameter. Sterilization: ETO (SAL 10^-6).

Indications for Use

Indicated for patients requiring uncemented primary or revision hemiarthroplasty of the hip due to femoral neck and trochanteric fractures of the proximal femur, osteonecrosis of the femoral head, or failed prior treatments/devices.

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

• Apex Hip System Bipolar Head (K082468)
• K945793
• K931655

Submission Summary (Full Text)

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OMNI life science Apex Hip System Bipolar Head

| Submitter | OMNI life science, Inc.<br>50 O'Connell Way<br>E. Taunton MA 02718 |
|------------------|--------------------------------------------------------------------|
| Contact | Robert Zoletti<br>VP Regulatory Affairs<br>774-226-1845 |
| Preparation Date | April 8, 2010 |

MAY 2 8 2010

| Device Name | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Hemi-hip prosthesis, uncemented |
| Trade Name | Apex Hip System Bipolar Head |
| Classification Name | Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis<br>Orthopedic (OR) |
| Regulatory Class | Class II per 21 CFR §888.3390 |
| Product Code | KWY |
| Legally Marketed<br>Predicate Device(s) | Apex Hip System Bipolar Head<br>K 082468, K945793, K931655 |
| Device Description | The Apex Hip System Bipolar Head consists of a factory assembled Ultra High<br>Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell and<br>UHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outer<br>diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient<br>anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates<br>with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm)<br>have an inner diameter that mates with a 28 mm diameter femoral head. The Apex<br>Hip System Bipolar Head may be used in conjunction with an Apex Hip System<br>femoral stem (K060072) for hemiarthroplasty. |
| Indications for Use | The indications have not changed from the predicate. The Apex Hip System Bipolar<br>Head is intended for use in combination with an Apex Hip System femoral stem for<br>uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be<br>used for the following conditions, as appropriate:<br><ul><li>Femoral neck and trochanteric fractures of the proximal femur;</li><li>Osteonecrosis of the femoral head;</li><li>Revision procedures where other devices or treatments for these indications have failed.</li></ul> |
| Predicate Device<br>Comparison | The Apex Hip System Bipolar Head is identical to the Apex Hip System Bipolar Head<br>cleared in K082468 with the following exceptions:<br><ul><li>The UHMWPE (ASTM F-648) retaining ring in the Acetabular component was modified to increase the amount of interference/overlap between the retaining ring and the head.</li><li>A Retaining Spring (Ti-6Al-4V Eli) was added to the UHMWPE Retaining Ring.</li></ul> |
| Non-Clinical Test<br>Summary | The following tests were conducted:<br><ul><li>Push-out and lever-out testing.</li><li>Locking ring spring storage heat tolerance test (150°F).</li><li>ETO sterilization validation, SAL 10⁶</li></ul> |
| Clinical Test<br>Summary | No clinical studies were performed. |
| Conclusions | The Apex Hip System Bipolar head is substantially equivalent to the predicate device. |

rage

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is oriented to follow the curve of the circle.

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

OMNI Life Science, Inc. % Mr. Robert Zoletti VP Regulatory Affairs 175 Paramount Drive Raynham, MA 02767

MAY 2 8 2010

#### Re: K100151

Trade/Device Name: Apex Hip System Bipolar Head 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: May 21, 2010 Received: May 26, 2010

Dear Mr. Robert Zoletti:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 -Mr. Robert Zoletti

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 CER.Part.803.), please go-to_

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 yours,

Mark A. Wilkerson

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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# K100151

# Indications for Use

### 510(k) Number (if known): K100151

Device Name: Apex Hip System Bipolar Head

Indications For Use:

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented 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 |
|-----------------------------|---|
| (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)

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

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