Alteon Acetabular Cup System

K182502 · Exactech, Inc. · LPH · Mar 13, 2019 · Orthopedic

Device Facts

• Record ID: K182502
• Device Name: Alteon Acetabular Cup System
• Applicant: Exactech, Inc.
• Product Code: LPH · Orthopedic
• Decision Date: Mar 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• 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 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

The Exactech Alteon Acetabular Cup System consists of metallic acetabular cups with Asymmatrix porous coating and UHMWPE liners (blended with vitamin E) for total hip arthroplasty. The system is designed for press-fit fixation. The device is used by orthopedic surgeons in a clinical/surgical setting. It functions as a prosthetic hip component to replace diseased or damaged hip joints, restoring mobility and reducing pain. The system is available in various sizes and geometries to accommodate patient anatomy. The device is implanted using standard surgical techniques and instrumentation. Benefits include improved joint function and stability for patients requiring hip replacement.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing and engineering analyses, including wear, impingement, range of motion, and mechanical disassembly testing (ASTM F1820-13). Pyrogen testing was performed per USP <161>, USP <85>, and ANSI/AAMI ST72.

Technological Characteristics

Metallic acetabular cups with Asymmatrix porous coating for press-fit fixation. Liners are Type 1 ultra-high molecular weight polyethylene (UHMWPE) blended with vitamin E. Mechanical testing performed per ASTM F1820-13. Sterility and pyrogen testing per USP <161>, USP <85>, and ANSI/AAMI ST72.

Indications for Use

Indicated for skeletally mature individuals undergoing primary hip replacement for osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative hip problems, 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/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Exactech AcuMatch® A-Series (K993082)
• Exactech Novation® Crown Cup (K070479)
• Exactech Novation® Crown Cup Line Extensions (K100269)
• Exactech E-HXL AcuMatch and Novation Acetabular Liners (K173583)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 13, 2019

Exactech, Inc Patrick Hughes Regulatory Affairs Manager 2320 NW 66th CT Gainesville, Florida 32653

Re: K182502

Trade/Device Name: Exactech® Alteon® Acetabular Cup System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, JDI, OQI Dated: February 14, 2019 Received: February 15, 2019

Dear Patrick Hughes:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 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 (OS) 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 mediation-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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

# Daniel S. Ramsey -S 2019.03.13 15:50:59 -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) K182502

Device Name Exactech® Alteon® Acetabular Cup System

#### 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 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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## Exactech® Alteon® Acetabular Cup System Traditional 510(k) K182502 510(k) Summary of Safety and Effectiveness

- Exactech, Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: [phone] [phone] Fax:

FDA Establishment Number 1038671

- Contact: Patrick Hughes Regulatory Affairs Manager
- Date: March 13, 2019

510(k) submission Number: K182502

Trade or Proprietary or Model Name(s): Exactech® Alteon® Acetabular Cup System

Common Name: Total Hip Prosthesis Acetabular Component

Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Product Code: LPH, JDI, OQI

Classification Panel: Orthopedic

Regulation Number 888.3358

Device Class II

#### Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---------------|-----------------------------------------------------------|---------------|
| K993082 | Exactech AcuMatch® A-Series | Exactech, Inc |
| K070479 | Exactech Novation® Crown Cup | Exactech, Inc |
| K100269 | Exactech Novation® Crown Cup Line Extensions | Exactech, Inc |
| K173583 | Exactech E-HXL AcuMatch and Novation<br>Acetabular Liners | Exactech, Inc |

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# Exactech® Alteon® Acetabular Cup System Traditional 510(k) K182502 510(k) Summary of Safety and Effectiveness

## 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.
- o Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

## Device Description:

Proposed Exactech Alteon Acetabular Cup System implants are acetabular components intended for use as part of total hip arthroplasty. Alteon Acetabular Cup System implants share key design features, materials, Indications for Use statements, geometry, and compatibility with other Exactech acetabular components marketed under the brand names AcuMatch and Novation.

The Alteon Acetabular Cup System includes metallic acetabular cups that feature an Asymmatrix™ porous coating, intended to make the devices compatible with press-fit total hip arthroplasty. Like predicate AcuMatch and Novation liners, Alteon XLE liners are manufactured from Type 1 ultra-high molecular weight polyethylene (UHMWPE) blended with vitamin E. Both cups and liners are available in a range of sizes and geometries intended to give surgeons options for meeting the needs of a range of patient anatomies.

The proposed devices operate using the same fundamental scientific technology, have the same intended use and design features, employ the same materials of construction, are offered in the same product size scopes, and are implanted using a similar surgical technique and the same or similar instrumentation. The only modifications proposed by this submission are dimensional.

## Testing Description:

This submission references mechanical testing results and engineering analyses for:

- . Wear
- Impingement
- Offset pull-out disengagement per ASTM F1820-13 .
- Axial disassembly per ASTM F1820-13 ●
- . Torque-out disassembly per ASTM F1820-13
- o Range of motion

Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSVAAMI ST72 to ensure the proposed Truliant 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.

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# Exactech® Alteon® Acetabular Cup System Traditional 510(k) K182502 510(k) Summary of Safety and Effectiveness

# Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate proposed Alteon Acetabular Cup System devices are substantially equivalent to cited cleared predicate AcuMatch and Novation acetabular cups and liners.