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 proposed Exactech Alteon HA Femoral Stems are intended for press-fit hip arthroplasty.

The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V ELI (per ASTM F136, ASTM F620) with a grit blast surface and HA coating (per ISO 13779-2). The stem has a 12/14 taper. The Alteon HA 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 compatible with the same femoral components as the predicate:

Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392)
Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)
Exactech BIOLOX forte Alumina Femoral Heads (K032964, K051682)
Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters (K103012,K121392)
AcuMatch L-series Unipolar endoprostheses (K010081)
AcuMatch L-Series Bipolar Endoprostheses (K013211) .
The Alteon HA Femoral Stems are compatible with the same acetabular components as the predicate:
AcuMatch A-Series Acetabular Shells and Liners (K993082, K042906)
AcuMatch A-Series Acetabular GXL Liners (K051556)
AcuMatch A-Series Acetabular Cups, All-polyethylene, Cemented (K963313)
Novation Crown Cup Acetabular Shells and Liners (K070479, K100269, K121392, K141960)
Novation Crown Cup Acetabular Shells with InteGrip (K102975)
Novation Crown Cup Constrained Liners and Rings (K071676)
Exactech Integrip Acetabular Shells (K122798)
Exactech Novation and AcuMatch E-HXL Acetabular Liners (K173583)
Exactech Alteon Acetabular Cup System (K182502)

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a medical device called "Alteon® HA Femoral Stems." It's important to understand that a 510(k) is a submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device, not a study proving device performance against specific acceptance criteria in the context of an AI/software device.

Therefore, the requested information pertaining to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/software device is not applicable to this FDA submission. This submission is for a physical orthopedic implant (a femoral stem for hip replacement), not a "device" in the sense of an AI algorithm or diagnostic software.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on proving performance against specific acceptance criteria for a new, innovative diagnostic or AI-driven capability.

Here's a breakdown based on the context of the provided document, addressing why many of the requested fields cannot be filled:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the context of performance metrics for an AI/software device. The "acceptance" here is the FDA's determination of substantial equivalence.
- Reported Device Performance: The document describes non-clinical testing performed to show the new HA coating does not negatively impact the device's essential characteristics, maintaining equivalence to the predicate. Performance is demonstrated through engineering analyses (Range of Motion, Stem Neck Fatigue, Distal Stem Fatigue) and characterization of the new HA coating, ensuring it meets standards like ISO 21535:2007, ASTM F2068-2015, ISO 7206-6:2013, ISO 7206-4:2010, ISO 13779-2, and USP <161>, USP <85>, ANSI/AAMI ST72. No quantitative performance metrics in the sense of sensitivity, specificity, etc., for a diagnostic task are provided or relevant.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This is not applicable. The "test set" in the context of this 510(k) refers to the physical devices undergoing mechanical and chemical testing. There's no data set of patient images or information from which "data provenance" would be relevant.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. There is no ground truth, expert consensus, or image review involved for this type of medical device submission. The "ground truth" for a mechanical implant is its physical and chemical properties and mechanical integrity, which are assessed through engineering tests, not expert medical review.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This refers to adjudication of medical image interpretations, which is not part of this submission. Mechanical testing results are objective measurements against established standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is for AI-powered diagnostic devices. The device in question is a physical orthopedic implant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is for AI algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the sense of a clinical ground truth for a diagnostic device. The "truth" for this device's performance is adherence to established engineering and material standards.
The sample size for the training set:
- Not applicable. There is no AI model or "training set" for this physical implant.
How the ground truth for the training set was established:
- Not applicable. There is no AI model or "training set" for this physical implant.

Summary of Relevant Information from the Document (Re-framed to align with the FDA 510(k) context):

The submission is for the Alteon® HA Femoral Stems, demonstrating substantial equivalence to the predicate device K162732 Exactech® Alteon® HA Femoral Stems. The key difference is the hydroxyapatite (HA) coating material/process.

The "study" conducted for this submission involves non-clinical testing and engineering analyses to demonstrate that the proposed device performs as intended and is substantially equivalent to the predicate.

Non-Clinical Tests and Analyses Done:

Engineering analysis of Range of Motion (ROM): Per ISO 21535:2007.
Engineering analysis of Stem Neck Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-6:2013.
Engineering analysis of Distal Stem Fatigue Testing: Per ASTM F2068-2015 and ISO 7206-4:2010.
HA coating characterization: Per ISO 13779-2 and FDA Guidance document, "510(k) Information Needed for Hydroxyapatite Coated Orthopaedic Implants," dated February 1997.
Bacterial endotoxins: Per USP <161>, USP <85>, and ANSI/AAMI ST72.

Conclusion from Testing:
The non-clinical testing and analysis found that the difference in the applied HA coating does not change the intended use, safety, or performance requirements of the proposed devices, nor does it adversely affect their safety or effectiveness. This supports the claim of substantial equivalence to the predicate device. No clinical testing was submitted.

To reiterate, the framework provided in the request is designed for evaluating AI/software-as-medical-device (SaMD) products, which is not what the Alteon® HA Femoral Stems are.

Summary

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March 10, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Exactech, Inc. Pedro Ravelo Regulatory Affairs Specialist 2320 NW 66th Ct. Gainesville, Florida 32653

Re: K243839

Trade/Device Name: Alteon® HA Femoral Stems 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: December 11, 2024 Received: December 13, 2024

Dear Pedro Ravelo:

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 (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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

RYAN TROMBETTA -S

For: Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K243839

Device Name Alteon® HA Femoral Stems

Indications for Use (Describe)

Exactech Alteon HA femoral stems are intended for press-fit 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® HA Femoral Stems Traditional 510(k) - 510(k) Summary

Contact Details

Applicant Name:	Exactech, Inc.
Applicant Address:	2320 NW 66th Ct. Gainesville FL 32653 United States
Applicant Contact Telephone:	352-377-1140
Applicant Contact:	Mr. Pedro Ravelo
Applicant Contact Email:	pedro.ravelo@exac.com
Date Prepared:	07 March 2025
Device Name
Device Trade Name:	Alteon® HA Femoral Stems
Common Name:	Femoral Stem
Classification Name:	Hip joint metal/ceramic/polymer semi-constrained cementedor nonporous uncemented prosthesis
Regulation Number:	888.3353
Product Code(s):	MEH

Legally Marketed Predicate Devices

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K162732	Exactech® Alteon® HA Femoral Stems	MEH

Device Description Summary

The proposed Exactech Alteon HA Femoral Stems are intended for press-fit hip arthroplasty.

The Alteon HA Femoral Stems are compatible with the same femoral components as the predicate:

Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392) ●
Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)
Exactech BIOLOX forte Alumina Femoral Heads (K032964, K051682)
Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters (K103012,K121392) ●
AcuMatch L-series Unipolar endoprostheses (K010081) ●

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Exactech® Alteon® HA Femoral Stems Traditional 510(k) - 510(k) Summary

AcuMatch L-Series Bipolar Endoprostheses (K013211) .
The Alteon HA Femoral Stems are compatible with the same acetabular components as the predicate:
AcuMatch A-Series Acetabular Shells and Liners (K993082, K042906) ●
AcuMatch A-Series Acetabular GXL Liners (K051556)
AcuMatch A-Series Acetabular Cups, All-polyethylene, Cemented (K963313) ●
Novation Crown Cup Acetabular Shells and Liners (K070479, K100269, K121392, ● K141960)
Novation Crown Cup Acetabular Shells with InteGrip (K102975)
Novation Crown Cup Constrained Liners and Rings (K071676)
Exactech Integrip Acetabular Shells (K122798)
Exactech Novation and AcuMatch E-HXL Acetabular Liners (K173583) ●
Exactech Alteon Acetabular Cup System (K182502)

Intended Use/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, posttraumatic 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.

Indications for Use Comparison

The subject device and the predicate device have the same indications for use.

Technological Comparison

The subject device and the predicate have the same intended use and basic fundamental scientific technology. The rationale for substantial equivalence between the subject device and the predicate device is based on consideration of the following:

The subject and predicate devices have the same indications for use. ●
The subject and predicate devices are composed of the same or similar biocompatible materials.
The subject and predicate devices have the same design features. ●
The subject and predicate devices have the same dimensions.
The subject and predicate devices are provided sterile for single use only
The subject and predicate devices conform to the same recognized performance standards. ●

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Exactech® Alteon® HA Femoral Stems Traditional 510(k) - 510(k) Summary

The only difference between the subject device and the predicate device is the hydroxyapatite (HA) coating material/process applied to the stem.

Non-Clinical and/or Clinical Tests Summary & Conclusions

The following non-clinical testing and engineering analyses were conducted to demonstrate the proposed Alteon HA Femoral Stems perform as intended and are substantially equivalent to the identified predicate devices:

Engineering analysis of Range of Motion (ROM) per ISO 21535:2007 ●
Engineering analysis of Stem Neck Fatigue Testing per ASTM F2068-2015 and ISO 7206-6:2013
Engineering analysis of Distal Stem Fatigue Testing per ASTM F2068-2015 and ISO 7206-● 4:2010
HA coating characterization per ISO 13779-2 and FDA Guidance document, 510(k) . Information Needed for Hydroxyapatite Coated Orthopaedic Implants, dated February 1997
Bacterial endotoxins per USP <161>, USP <85> and ANSI/AAMI ST72

There is no clinical testing being submitted as part of this submission.

The difference in the applied HA coating does not change the intended use, safety, or performance requirements of the proposed devices, nor does it adversely affect their safety or effectiveness. This conclusion is based on consideration of nonclinical testing and analysis, including range of motion, fatigue, coating characterization, and biocompatibility assessments completed to establish substantial equivalence of the proposed devices to the 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.