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 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.

AI/ML Overview

This document describes the Exactech® Alteon® Monobloc Revision Stem and its line extensions. It is a 510(k) premarket notification, indicating that the device is being submitted for clearance based on its substantial equivalence to a predicate device, not through a study proving it meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. This submission focuses on comparing the new device to a previously cleared device (K150066) to demonstrate substantial equivalence based on design, materials, and non-clinical testing, rather than a clinical study evaluating diagnostic performance.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

This document does not specify general "acceptance criteria" in the way one would for a diagnostic or AI device's performance (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate device through non-clinical testing.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (Non-Clinical Testing)
Fatigue Performance: Must perform comparably to the predicate device and meet relevant engineering standards for fatigue strength.	Fatigue testing was performed to demonstrate that the Exactech Alteon Monobloc Revision Stem line extensions perform as intended and are substantially equivalent to the identified predicate devices. (No specific numerical results or thresholds are provided in this summary.)
Range of Motion: Must allow for a comparable range of motion to the predicate device.	Range of motion analysis was performed. (No specific numerical results are provided in this summary.)
Pyrogenicity: Must meet recommended limits for pyrogens for devices labeled as sterile.	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. (No specific numerical results are provided in this summary.)
Design Features and Geometry: Must be identical or acceptably similar where differences are justified and not affecting safety or effectiveness.	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. (Note: The line extensions offer longer stem lengths, reduced neck offsets, and intermediately sized stem diameters, which are considered variations within existing design principles and are justified by the "array of patient anatomies" they accommodate, not presenting a new risk).
Materials and Surface Finishes: Must be identical or acceptably similar.	Both the proposed and predicate devices are identical per: Materials and surface finishes.
Intended Use and Indications for Use: Must be identical.	Both the proposed and predicate devices are identical per: The Indications for Use, The intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This document does not refer to a "test set" in the context of clinical data or AI performance evaluation. The "testing" refers to non-clinical, bench-top engineering tests (fatigue, range of motion, pyrogenicity). The sample sizes for these engineering tests are not specified in this summary.
Data Provenance: Not applicable as no clinical data or patient-specific data is involved in this summary for demonstrating substantial equivalence. The data comes from internal laboratory testing.

3. 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. "Ground truth" usually refers to a definitive diagnosis or outcome for clinical data. This submission is based on non-clinical engineering testing, not expert interpretation of clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to clinical data review by experts, not to non-clinical engineering tests.

5. 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 device is an orthopedic implant, not a diagnostic imaging device or an AI-powered tool. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the accepted engineering standards for performance and material properties (e.g., USP <161>, USP <85>, ANSI/AAMI ST72 for pyrogen testing, and general industry standards for fatigue strength and range of motion for hip implants). This is not clinical ground truth.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set ground truth."

Summary

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

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

Sponsor:	Exactech®, Inc.2320 N.W. 66th CourtGainesville, FL 32653
	Phone: (352) 377-1140Fax: (352) 378-2617
	FDA Establishment Number 1038671
Contact:	Zach SharrahRegulatory Affairs SpecialistTelephone: (352) 377-1140Fax: (352) 378-2617
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:

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.

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.