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 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.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device, the Exactech® Alteon® Highly Polished Femoral Stem. It is not an AI/ML device, and therefore, the requested information regarding acceptance criteria, study details, and AI-specific metrics (such as MRMC studies, standalone performance, training set details, or expert ground truth adjudication) is not applicable.

The document discusses the device's substantial equivalence to a predicate device (Avenir Cemented Hip Stem, K131884) based on its indications for use, technological characteristics, and non-clinical testing.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the way one might for an AI device's performance metrics (e.g., specific sensitivity/specificity thresholds). Instead, it describes performance requirements through non-clinical testing designed to demonstrate that the device performs as intended and is substantially equivalent to predicate devices.

Acceptance Criteria (Implied by testing)	Reported Device Performance (Demonstrated by testing)
Mechanical integrity under fatigue loads (distal and proximal)	Testing performed to demonstrate performance as intended.
Proper range of motion	Range of Motion Analysis performed.
Femoral head compatibility (burst strength, fatigue, post-fatigue burst, pull-off)	Femoral Head Compatibility Testing performed.
Geometric similarity to existing stems	Geometry Comparison of Alteon® HPS to Alteon® HA Femoral Stem performed.
Sterility and absence of pyrogens	Pyrogen testing conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72; meets recommended limits per FDA guidance.
Conformance to recognized performance standards for total hip replacement devices	Device conforms to recognized performance standards.

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

This information is not applicable as the studies described are non-clinical (mechanical and material testing), not clinical studies involving patient data or a "test set" in the context of AI. The tests involve physical samples of the device.

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

This information is not applicable. Ground truth, in the context of device performance, is established through standardized engineering tests and material science principles, not expert consensus on diagnostic or prognostic classifications.

4. Adjudication Method:

Not applicable for non-clinical, engineering-based testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is not an AI algorithm. The performance described is for a physical medical prosthetic.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established by engineering standards, material properties, and biomechanical principles. For instance, the pyrogen testing relies on established biological assay standards (USP, ANSI/AAMI ST72) to determine the absence of pyrogens. Mechanical tests like fatigue testing rely on established engineering methodologies to assess durability under simulated physiological loads.

8. Sample Size for the Training Set:

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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.2320 NW 66th CourtGainesville FL, 32653Phone: (352) 377-1140Fax: (352) 378-2617
	FDA Establishment Number: 1038671
Date:	September 7, 2018
Contact Person:	Zach SharrahSr. Regulatory Affairs SpecialistTelephone: (352) 327-1140Fax: (352) 378-2617
Proprietary Name:	Exactech® Alteon® Highly Polished Femoral Stem
Common Name:	Femoral Hip Stem
Classification Name:	Hip joint metal/ceramic/polymer semi-constrained cemented ornon-porous uncemented prosthesis (21 CFR 888.3353, Class II,Product Code: LZO)
	Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis (21 CFR 888.3360, Class II, Product Code: LWJ)
	Hip joint femoral (hemi-hip) metallic cemented or uncementedprosthesis (21 CFR 888.3360, Class II, Product Code: KWL)
	Hip joint metal/polymer constrained cemented or uncementedprosthesis (21 CFR 888.3310, Class II, Product Code: KWZ)
	Hip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis (21 CFR 888.3390, Class II,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:

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.

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.