Exactech Alteon Highly Polished Femoral Stem

K182462 · Exactech, Inc. · LZO · Nov 8, 2018 · Orthopedic

Device Facts

• Record ID: K182462
• Device Name: Exactech Alteon Highly Polished Femoral Stem
• Applicant: Exactech, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Nov 8, 2018
• 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 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 stock is present, and to restore mobility resulting from previous fusion. Exactech® Highly Polished Femoral Stems are intended for cemented fixation.

Device Story

Exactech® Alteon® Highly Polished Femoral Stem is a metallic hip prosthesis for cemented fixation. Device is implanted by orthopedic surgeons during primary or revision hip arthroplasty. Input is patient anatomy; device provides structural support for hip joint. Features include forged Cobalt Chromium Alloy (Co-28Cr-6Mo) construction, polished surface finish, 12/14 taper, and trapezoidal cross-section. Available in various lengths, offsets, and diameters to match patient anatomy. Used in clinical settings; provides stable femoral component for hip replacement, restoring mobility and joint function.

Clinical Evidence

Bench testing only. Testing included distal and proximal fatigue testing, range of motion analysis, and femoral head compatibility testing (burst, fatigue, post-fatigue burst, and pull-off). Pyrogen testing performed per USP <161>, USP <85>, and ANSI/AAMI ST72.

Technological Characteristics

Material: Forged Cobalt Chromium Alloy (Co-28Cr-6Mo). Design: Collarless, trapezoidal cross-section, distal taper, 12/14 taper neck. Surface: Highly polished. Sterilization: Provided sterile for single use. Conforms to recognized performance standards for total hip replacement devices.

Indications for Use

Indicated for skeletally mature individuals requiring primary hip replacement or revision due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip conditions, proximal femoral fractures, ankylosing spondylitis, or congenital hip dysplasia. Intended for cemented fixation.

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

• Avenir Cemented Hip Stem (K131884)

Submission Summary (Full Text)

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November 8, 2018

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Exactech®, Inc. Zach Sharrah Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

## Re: K182462

Trade/Device Name: Exactech® Alteon® Highly Polished 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: LZO, LWJ, KWL, KWZ, KWY Dated: September 7, 2018 Received: September 10, 2018

# Dear Zach Sharrah:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website

(http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Daniel S. Ramsey -S 2018.11.08 17:31:06 -05'00'

For 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

510(k) Number (if known) K182462

Device Name

Exactech® Alteon® Highly Polished 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 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 stock is present, and to restore mobility resulting from previous fusion.

Exactech® Highly Polished Femoral Stems are intended for cemented fixation.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Exactech® Alteon® Highly Polished Femoral Stem Traditional 510(k) – 510(k) Summary

| Sponsor: | Exactech®, Inc.<br>2320 NW 66th Court<br>Gainesville FL, 32653<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | FDA Establishment Number: 1038671 |
| Date: | September 7, 2018 |
| Contact Person: | Zach Sharrah<br>Sr. Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| Proprietary Name: | Exactech® Alteon® Highly Polished Femoral Stem |
| Common Name: | Femoral Hip Stem |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>non-porous uncemented prosthesis (21 CFR 888.3353, Class II,<br>Product Code: LZO) |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented<br>prosthesis (21 CFR 888.3360, Class II, Product Code: LWJ) |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented<br>prosthesis (21 CFR 888.3360, Class II, Product Code: KWL) |
| | Hip joint metal/polymer constrained cemented or uncemented<br>prosthesis (21 CFR 888.3310, Class II, Product Code: KWZ) |
| | Hip joint femoral (hemi-hip) metal/polymer cemented or<br>uncemented prosthesis (21 CFR 888.3390, Class II,<br>Product Code: KWY) |

# Legally Marketed Device to Which Substantial Equivalence Is Claimed:

| Name | Manufacturer | 510(k) Number |
|--------------------------|--------------|---------------|
| Avenir Cemented Hip Stem | Zimmer | K131884 |

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# Exactech® Alteon® Highly Polished Femoral Stem Traditional 510(k) - 510(k) Summarv

#### Indication for 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 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® Highly Polished Femoral Stems are intended for cemented fixation.

#### Device Description:

The Exactech® Alteon® Highly Polished Femoral Stem implants are manufactured from forged Cobalt Chromium Alloy (Co-28Cr-6Mo) with a polished neck finish and polished surface finish. The Alteon® Highly Polished Femoral Stems are available in different combinations of stem length, neck offset, and diameter to accommodate an array of patient anatomies. The femoral stem has a 12/14 taper and has a trapezoidal cross-sectional stem geometry with a distal taper.

Alteon® Highly Polished Femoral Stem implants are collarless femoral stems and are intended for cemented use only.

## Summary of Technological Characteristics:

The rationale for substantial equivalence of the proposed Exactech® Alteon® Highly Polished Femoral Stems to the predicate and reference devices is based on consideration of the following device use and characteristics:

- · Indications for Use. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device have similar Indications for Use statements. Both proposed and predicate device are indicated for osteoarthritis, rheumatic diseases, post-traumatic degenerative problems, and revision of failed previous reconstructions. Both proposed and predicate device are indicated for hemi or total hip arthroplasty.
- · Materials/Surface Finish/Coatings, Like the predicate device, the proposed Exactech® Alteon® Highly Polished Femoral Stem is a metallic implant with a highly polished surface finish for permanent implantation at the same site of the body.

· Design Features. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device share the same design features; 12/14 taper geometry, neck axis, standard and extended offsets, and offered in a collarless design.

- · Dimensions. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device have similar neck offset and stem length dimensions.
· Sterilization. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device are provided sterile for single use only.

· Performance Requirements. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device conform to recognized performance standards for total hip replacement devices.

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## Exactech® Alteon® Highly Polished Femoral Stem Traditional 510(k) - 510(k) Summarv

#### Non-Clinical Testing:

The following non-clinical testing has been performed to demonstrate that the Exactech® Alteon® Highly Polished Femoral Stems perform as intended and are substantially equivalent to the identified predicate devices:

- Distal Fatigue Testing ●
- Proximal Fatigue Testing
- Range of Motion Analysis
- o Femoral Head Compatibility Testing including; burst testing, fatigue testing, post-fatigue burst testing, and pull-off
- · Geometry Comparison of Alteon® HPS to Alteon® HA Femoral

Stem

Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to ensure the proposed Exactech® Alteon® Highly Polished Femoral Stems 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:

Based on consideration of Indications for Use, technological characteristics, and results of nonclinical testing referenced in this submission. it is concluded that the proposed Exactech® Alteon® Highly Polished Femoral Stems are substantially equivalent to the cited cleared predicate devices.