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 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 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.

AI/ML Overview

This FDA 510(k) summary for the Exactech® Alteon® HA Femoral Stem focuses on demonstrating substantial equivalence to an existing predicate device (Exactech Novation Element Press-Fit Femoral Stem), rather than proving the device meets specific performance criteria through a clinical study or an AI-driven evaluation.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance is not included in this document. This type of information is typically associated with the evaluation of artificial intelligence/machine learning (AI/ML) devices, diagnostics, or other devices requiring direct performance validation against clinical outcomes or expert labels.

The provided document describes a traditional 510(k) submission for a Class II medical device (hip joint prosthesis). For such medical devices, "acceptance criteria" primarily relate to:

Mechanical performance: Ensuring the device can withstand physiological loads and wear over time.
Biocompatibility: Confirming the materials are safe for implantation.
Sterility: Verifying the device is sterile when packaged.
Design and manufacturing controls: Ensuring consistent quality.

The "study that proves the device meets the acceptance criteria" in this context refers to benchtop engineering testing, not clinical trials or diagnostic performance studies involving human subjects' data interpretation.

Summary of what is present in the document related to "acceptance criteria" and "proof":

Acceptance Criteria and Proof (as per this 510(k) document)

The document outlines engineering analyses conducted to prove the device's mechanical properties. These are the de facto acceptance criteria for this type of device in a 510(k) submission seeking substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Type of Testing)	Reported Device Performance (Implied "Meets Standards")
Distal Fatigue Testing	Results demonstrate substantial equivalence
Proximal Fatigue Testing	Results demonstrate substantial equivalence
Range of Motion Analysis	Results demonstrate substantial equivalence
Pyrogen Testing	Met recommended limits per FDA's Guidance Document

Note: The document states "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." This implies that the performance in these tests was comparable to or better than the predicate device, thus meeting the unstated acceptance thresholds for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified for the engineering tests. For mechanical testing, this typically refers to the number of physical samples of the device tested, not patient data.
Data Provenance: The tests are inherently prospective as they are specifically conducted for the regulatory submission. The "data" are generated in a laboratory setting (benchtop testing), not from patient populations. Country of origin for data is not applicable in the sense of patient demographics; the tests would be performed in a controlled environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. Ground truth in the context of diagnostic AI/ML algorithms relies on human expert consensus or clinical outcomes. For this mechanical device, "ground truth" is established by standard engineering principles, test methodologies (e.g., ISO standards, ASTM standards), and regulatory guidelines. The "experts" would be the engineers and technicians conducting the tests and the regulatory specialists evaluating the data.

4. Adjudication Method for the Test Set:

Not Applicable. Adjudication is relevant for conflicting interpretations of clinical data, especially in image-based diagnostics. For mechanical engineering tests, results are typically quantitative and objective measurements (e.g., cycles to failure, deflection, etc.).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

No. An MRMC study is specific to evaluating the diagnostic performance of human readers, often comparing performance with and without AI assistance. This device is a mechanical implant, not a diagnostic tool, so such a study is not relevant.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No. This refers to the standalone performance of an AI algorithm. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used:

Engineering Standards and Predicate Device Performance. The "ground truth" for this submission is established by demonstrating that the new device performs mechanically at least as well as the legally marketed predicate device when tested according to recognized engineering standards and methods. It's a comparative performance, not a clinical outcome or pathological diagnosis.

8. The Sample Size for the Training Set:

Not Applicable. "Training set" refers to data used to train AI/ML algorithms. This is a traditional medical device, not an AI/ML product.

9. How the Ground Truth for the Training Set was Established:

Not Applicable. See point 8.

In conclusion, this document demonstrates that the Exactech® Alteon® HA Femoral Stem meets the requirements for substantial equivalence for a 510(k) submission based on benchtop engineering testing, not clinical study data for diagnostic performance.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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®, Inc2320 NW 66th CourtGainesville FL, 32653
	Phone: (352) 377-1140Fax: (352) 378-2617
	FDA Establishment Number 1038671
Date:	April 25, 2017
Contact Person:	Thomas McNamara, RACRegulatory Affairs SpecialistTelephone: (352) 327-1140Fax: (352) 378-2617
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-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

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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.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
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.(b)
Classification. Class II.