Exactech® Alteon® HA Femoral Stem

K162732 · Exactech, Inc. · MEH · Apr 26, 2017 · Orthopedic

Device Facts

• Record ID: K162732
• Device Name: Exactech® Alteon® HA Femoral Stem
• Applicant: Exactech, Inc.
• Product Code: MEH · Orthopedic
• Decision Date: Apr 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.

Device Story

Exactech Alteon HA Femoral Stem is a hip prosthesis component for press-fit fixation in primary hip replacement surgery. Device is manufactured from Ti-6Al-4V alloy featuring a polished neck, grit-blasted surface, and hydroxyapatite (HA) coating on the stem body. Design includes trapezoidal cross-section, distal taper, and vertical/horizontal grooves to facilitate bone integration. Available in multiple lengths with standard/extended neck offsets and collarless configurations. Intended for use by orthopedic surgeons in clinical settings. Device replaces damaged femoral head/neck to restore hip joint function and mobility. Not intended for use with bone cement.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including distal fatigue testing, proximal fatigue testing, and range of motion analysis. Pyrogen testing was conducted per USP <161>, USP <85>, and ANSI/AAMI ST72.

Technological Characteristics

Material: Ti-6Al-4V. Surface: Grit blast with HA coating. Geometry: Trapezoidal cross-section, distal taper, vertical/horizontal grooves. Connection: 12/14 taper. Fixation: Press-fit (uncemented). Sterilization: Not specified, but testing follows ANSI/AAMI ST72.

Indications for Use

Indicated for skeletally mature individuals requiring primary hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip conditions, or proximal femoral fractures. Also indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed reconstructions with sufficient bone stock, and restoration of mobility after fusion.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Exactech Novation Element Press-Fit Femoral Stem (K153649)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending downward from the bottom profile.

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

April 26, 2017

Exactech, Inc. Thomas McNamara, RAC Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

Re: K162732 Trade/Device Name: Exactech® Alteon® HA Femoral Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: MEH Dated: February 27, 2017 Received: March 1, 2017

Dear Mr. McNamara:

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. Isting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K162732

p.1/1

Device Name

Exactech® Alteon® HA Femoral Stem

#### Indications for Use (Describe)

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Exactech Alteon HA femoral stems are intended for press-fit fixation.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# Exactech® Alteon® HA Femoral Stems Traditional 510(k) - 510(k) Summary

| Sponsor: | Exactech®, Inc<br>2320 NW 66th Court<br>Gainesville FL, 32653 |
|-------------------|-----------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| | FDA Establishment Number 1038671 |
| Date: | April 25, 2017 |
| Contact Person: | Thomas McNamara, RAC<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| Proprietary Name: | Exactech® Alteon® HA Femoral Stems |
| Common Name: | Femoral Stem |

#### Classification Name:

Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis, 21 CFR 888.3353, Class II, Product Code MEH

### Legally Marketed Device to Which Substantial Equivalence Is Claimed:

| Name | Manufacturer | 510(k) Number |
|------------------------------------------------------|---------------|---------------|
| Exactech Novation Element Press-<br>Fit Femoral Stem | Exactech, Inc | K153649 |

### Indication for Use:

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, theumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Exactech Alteon HA femoral stems are intended for press-fit fixation.

### Device Description

The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V with a polished neck region, grit blast surface and HA coating on the stem body. The stem has a 12/14 taper. The Alteon HA Femoral Stems Femoral Stems are available in various lengths with standard and

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## Exactech® Alteon® HA Femoral Stems Traditional 510(k) - 510(k) Summary

extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.

The Alteon HA Femoral Stems are intended for press-fit applications and are not intended for use with bone cement.

### Testing:

An engineering analysis was conducted to evaluate the mechanical properties of the proposed Alteon HA Femoral Stems, including:

- Distal Fatigue Testing ●
- Proximal Fatigue Testing ●
- Range of Motion Analysis ●

Pyrogen testing was conducted in accordance with USP <161>. USP <85>. and ANSVAAMI ST72 to meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.

### Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Exactech Alteon HA Femoral Stems are substantially equivalent to the cleared Exactech Novation Element Press-Fit Femoral Stem.