Exactech Alteon Monobloc Revision Stem

K181532 · Exactech, Inc. · LZO · Sep 4, 2018 · Orthopedic

Device Facts

• Record ID: K181532
• Device Name: Exactech Alteon Monobloc Revision Stem
• Applicant: Exactech, Inc.
• Product Code: LZO · Orthopedic
• Decision Date: Sep 4, 2018
• Decision: SESE
• Submission Type: Special
• 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. - Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. - Press-fit femoral stems and acetabular cups are intended for press-fit fixation. - Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Story

Distally tapered, press-fit femoral prosthesis; used in total or hemi hip arthroplasty; features 12/14 trunnion. Line extensions provide longer stem lengths, reduced neck offsets, and intermediate diameters to accommodate varied patient anatomies. Implanted by orthopedic surgeons in clinical settings. Device restores hip joint function; provides stability for patients with degenerative hip conditions or fractures. Substantially equivalent to existing Alteon Monobloc Revision Stems.

Clinical Evidence

Bench testing only. Fatigue testing and range of motion analysis performed. Pyrogen testing conducted per USP <161>, USP <85>, and ANSI/AAMI ST72.

Technological Characteristics

Distally tapered, press-fit femoral stem; 12/14 trunnion. Materials and surface finishes identical to predicate. Sterilization per FDA guidance.

Indications for Use

Indicated for skeletally mature individuals requiring primary or revision hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degeneration, proximal femoral fractures, ankylosing spondylitis, congenital hip dysplasia, or to restore 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 Alteon Monobloc Revision Stem (K150066)

Submission Summary (Full Text)

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September 4, 2018

Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.

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

Re: K181532

Trade/Device Name: Exactech® Alteon® Monobloc Revision 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 Dated: August 13, 2018 Received: August 14, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 2018.09.04 13:55:13 -04'00'

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) K181532

#### Device Name

Exactech® Alteon® Monobloc Revision 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.

- · Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- · Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
- · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

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

| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# Exactech® Alteon® Monobloc Revision Stem Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness

| Sponsor: | Exactech®, Inc.<br>2320 N.W. 66th Court<br>Gainesville, FL 32653 |
|-------------------|---------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| | FDA Establishment Number 1038671 |
| Contact: | Zach Sharrah<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | 6 June 2018 |
| Proprietary Name: | Exactech® Alteon® Monobloc Revision Stem |
| Common Name: | Total Hip Arthroplasty – Femoral Components |

## Classification Name:

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (CFR 888.3353, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, Class II, Product Code LZO)

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

| Name | Manufacturer | 510(k) Number |
|----------------------------------------|----------------|---------------|
| Exactech Alteon Monobloc Revision Stem | Exactech, Inc. | K150066 |

## Indications 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.

- . Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. ●
- . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

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# Exactech® Alteon® Monobloc Revision Stem Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness

## Device Description:

The Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The Alteon Monobloc Revision Stem system is intended to treat typical Total Hip Arthroplasty primary and revision cases. Compared to predicate Alteon Monobloc Revision Stems implants, proposed Alteon Monobloc Revision Stem line extension implants offer a longer stem length option, a reduced neck offset option, and options for intermediately sized stem diameters to accommodate an array of patient anatomies.

Both the proposed and predicate devices are identical per:

- · The Indications for Use
- · The intended use
- · Design features and geometry
- · Materials and surface finishes
- · Implantation methods
- · Compatibility

# Non-Clinical Testing:

The following non-clinical testing has been performed to demonstrate that the Exactech Alteon Monobloc Revision Stem line extensions perform as intended and are substantially equivalent to the identified predicate devices:

- Fatigue testing
- Range of motion analysis ●

Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to ensure the proposed Alteon Monobloc Revision Stem line extension components 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:

Detailed feature comparison and results of testing referenced in this submission demonstrate the proposed Exactech Alteon Monobloc Revision Stem line extensions are substantially equivalent to the cited cleared predicate Exactech Alteon Monobloc Revision Stem devices.