The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or posttraumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.

Exactech Alteon Bone Screws 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. Exactech Alteon Bone Screws 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.

The Exactech Alteon Bone Screws are also indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Device Description

The tibial tray implant and its porous structure is manufactured from Ti-6Al-4V titanium alloy using electron beam melting (EBM) technology. This product line represents a scope extension of the Truliant knee implant system. The previously cleared Alteon Bone Screws are now cleared for use with the TRULIANT Porous Tibial Trays.

AI/ML Overview

This document does not describe a study involving an algorithm or AI. It is a 510(k) summary for a medical device (TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws), which means it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data from non-clinical (mechanical) testing.

Therefore, many of the requested categories, such as "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission.

Here's an analysis based on the information provided, focusing on the mechanical performance data:

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

Test Mode	Standard Used	Acceptance Criteria (Implied)	Reported Device Performance
Tibial tray fatigue	ASTM F1800-12	Sufficient for intended use and substantially equivalent to predicates	Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices.
Shear fatigue of an EBM porous structure	ASTM F1160-14 (2017)	Sufficient for intended use and substantially equivalent to predicates	Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices.
Static shear of an EBM porous structure	ASTM F1044-05 (2017)	Sufficient for intended use and substantially equivalent to predicates	Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices.
Static tension of an EBM porous structure	ASTM F1147-95 (2017)	Sufficient for intended use and substantially equivalent to predicates	Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices.
Static compression of an EBM porous structure	ASTM E9-09 (2018)	Sufficient for intended use and substantially equivalent to predicates	Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices.
Porous coating characterization	ASTM F1854-15	Sufficient for intended use and substantially equivalent to predicates	Results deemed sufficient for intended use and substantially equivalent to legally marketed predicate devices.
Pyrogenicity testing	Not specified (standard)	Endotoxin limit less than 20 EU/device	Endotoxin limit is less than 20 EU/device

Note: The document states that "The results of this non-clinical testing show that the strength of the TRULIANT Porous Tibial Tray is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The specific numerical acceptance criteria (e.g., minimum load or cycles) and quantitative results for the mechanical tests are not provided in this 510(k) summary, but are implicitly met as per the FDA's clearance.

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

This information is not provided in the given text. For mechanical testing, sample sizes are typically determined by the relevant ASTM standards, but the exact numbers are not mentioned here. The data provenance is also not specified, as this is non-clinical lab testing rather than patient data.

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)

This is not applicable as the document describes mechanical and pyrogenicity testing, not studies requiring expert review for ground truth in the context of medical image analysis or clinical outcomes.

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

This is not applicable for the type of testing described. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, not for standardized mechanical 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

This is not applicable. This document describes the clearance of a physical medical device (tibial tray and bone screws) through non-clinical testing, not an AI-powered diagnostic or assistive tool.

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

This is not applicable. This document does not pertain to an algorithm.

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

For the mechanical tests, the "ground truth" would be the physical properties and performance of the device under controlled laboratory conditions as measured against established ASTM standards. For pyrogenicity, it's the measured endotoxin level. This is not "expert consensus", "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set" and thus no ground truth to establish for it in this context.

Summary

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November 26, 2018

Exactech, Inc. % Meredith May Vice President Empirical Consulting LLC 4628 Northpark Dr. Colorado Springs, Colorado 80918

Re: K182346

Trade/Device Name: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Codes: MBH, JWH Dated: August 24, 2018 Received: August 28, 2018

Dear Meredith May:

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.

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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 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 (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 (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel S. Ramsey -S 2018.11.26 11:34:06 -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K182346 Device Name

TRULIANT Porous Tibial Trav

Indications for Use (Describe)

All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration

Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known)
K182346
Device Name
Exactech® Alteon® Bone Screws

Indications for Use (Describe)

The Exactech Alteon Bone Screws are also indicated for use in skeletally mature individuals undergoing primary surgerv for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including
the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any
other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB number."

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510(K) SUMMARY

Submitter's Name:	Exactech, Inc.
Submitter's Address:	2320 N.W. 66th CourtGainesville, Florida 32653
Submitter's Telephone:	(352) 378-2617
Contact Person:	Meredith Lee May MS, RACEmpirical Consulting719.337.7579MMay@EmpiricalConsulting.com
Date Summary was Prepared:	24-Aug-18
Trade or Proprietary Name:	TRULIANT Porous Tibial TrayAlteon Bone Screws
Common or Usual Name:	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerProsthesis, Knee, Patellofemorotibial, Semi-Constrained,Cemented, Polymer/Metal/Polymer
Classification:	Class II per 21 CFR §888.3565 and 21 CFR §888.3560
Product Code:	MBH, JWH
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

Indications for Use

The TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

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All TRULIANT Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only, except the TRULIANT Porous Tibial Trays, which are indicated for cemented or cementless use.

TECHNOLOGICAL CHARACTERISTICS

TRULIANT Porous Tibial Tray and Alteon Bone Screws are made from Ti-6Al-4V that conforms to ASTM F2924-14 or ASTM F136-13. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

Indications for Use o
Materials of manufacture ●
Method of manufacture ●
Mechanical strength .

510k Number	Trade or Proprietary orModel Name	Manufacturer	PredicateType
K123486	Triathlon Tritanium TibialBaseplates	Howmedica OsteonicsCorp (marketed byStryker)	Primary
K120990	NexGen® LCCK TrabecularMetal Coupled Tibial Cones	Zimmer TrabecularMetal Technology, Inc.	Additional
K153595	Optetrak Logic MetaphysealCones	Exactech, Inc.	Additional
K141797	Alteon 6.5mm Bone Screws	Exactech, Inc.	Additional

Table 5-1 Predicate Devices

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PERFORMANCE DATA

The TRULIANT Porous Tibial Tray has been tested in the following test modes:

Tibial tray fatigue per ASTM F1800-12 o
Shear fatigue of an EBM porous structure per ASTM F1160-14 (2017) ●
Static shear of an EBM porous structure per ASTM F1044-05 (2017) ●
Static tension of an EBM porous structure per ASTM F1147-95 (2017) o
Static compression of an EBM porous structure per ASTM E9-09 (2018) .
Porous coating characterization per ASTM F1854-15 o

The results of this non-clinical testing show that the strength of the TRULIANT Porous Tibial Tray is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. Pyrogenicity testing was also conducted and demonstrates that the endotoxin limit is less than 20 EU/device.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the TRULIANT Porous Tibial Tray and Alteon Bone Screws are substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.