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.

Device Description

Exactech Tapered Wedge Femoral Stem is a collarless, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The overall design goal of the Exactech Tapered Wedge Femoral Stem is to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal.

Manufactured from titanium alloy, the subject stem is available in 17 sizes with two lateral offsets offered for each size and two surface finish options (commercially pure titanium, and hydroxylapatite over commercially pure titanium) for the press-fit region of the device. Together, there are 68 total femoral stem configurations available to accommodate patients' various anatomical needs. Regardless of configuration, all Tapered Wedge Femoral Stems feature a polished neck region and bead blast (satin) surface finish on the distal region of the femoral stem. Exactech Tapered Wedge Femoral Stems are intended for press-fit applications. With respect to devicecompatibility with other Exactech manufactured products, Tapered Wedge Femoral Stem is designed to be used with the following 12/14 femoral heads and AcuMatch bipolar components.

The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:

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 BioloxOption Femoral Heads and Adapters (K103012, K121392)
Exactech AcuMatch L-series Unipolar endoprosthesis (K010081)

The proposed femoral stems are intended to mate with the following bipolar components:

Exactech AcuMatch L-Series Bipolar Endoprosthesis (K013211)
The Exactech Tapered Wedge Femoral Stem is accompanied by a complete instrumentation set including trial and broach/rasp system to assist surgeons in implantation of the device.

AI/ML Overview

The provided document describes the Exactech® Tapered Wedge Femoral Stem, a medical device for hip replacement surgeries. As such, it does not contain information about software or AI-powered devices, and therefore many of the questions regarding acceptance criteria and studies are not applicable in the context of AI.

However, I can extract information related to the device's performance based on the provided text, focusing on the available non-clinical testing.

Here's a breakdown of the requested information, adjusted for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" for each test with corresponding "reported device performance" in a typical table format that would be seen for a diagnostic algorithm. Instead, it states that the device "conforms to recognized performance standards for total hip replacement devices" and that specific tests were performed "to demonstrate that the Exactech Tapered Wedge Femoral Stem performs as intended and is substantially equivalent to the identified predicate devices."

Therefore, the "acceptance criteria" are implied to be meeting the requirements of the referenced standards and a successful demonstration of substantial equivalence. The "reported device performance" is the successful completion of these tests.

Test Type	Implied Acceptance Criteria	Reported Device Performance
Clinical Literature Review	Consistent with performance of similar femoral prostheses.	Successful completion of review, supporting substantial equivalence.
Template Studies	Demonstrated acceptable outcomes/characteristics.	Successful completion of studies, supporting substantial equivalence.
Range of Motion Testing (per ISO 21535)	Meets specified range of motion requirements per the standard.	Successful completion, demonstrating compliance with ISO 21535.
Distally Fixed Fatigue Testing (worst case per FDA guidance)	Withstands fatigue loads as per FDA guidance for worst-case scenarios.	Successful completion, demonstrating fatigue resistance per FDA guidance.
Femoral Neck Fatigue Testing (worst case per FDA guidance)	Withstands fatigue loads as per FDA guidance for worst-case scenarios.	Successful completion, demonstrating fatigue resistance per FDA guidance.
Femoral Head Modular Junction Burst Testing (per ISO 7206-10 and ASTM F2009-00)	Withstands burst pressure as per ISO 7206-10 and ASTM F2009-00.	Successful completion, demonstrating burst strength per standards.
Femoral Head Modular Junction Fatigue Testing (per ISO 7206-10 and ASTM F2009-00)	Withstands fatigue loads as per ISO 7206-10 and ASTM F2009-00.	Successful completion, demonstrating fatigue resistance per standards.
Femoral Head Modular Junction Axial Pull-off Testing (per ISO 7206-10 and ASTM F2009-00)	Withstands axial pull-off forces as per ISO 7206-10 and ASTM F2009-00.	Successful completion, demonstrating pull-off strength per standards.
Cadaveric Evaluation	Demonstrates proper implantation, fit, and function in a cadaveric model.	Successful completion, validating device performance in a cadaveric setting.
Microstructural Characterization & Mechanical Testing (dual coating)	Meets specified material and mechanical properties for the coating.	Successful completion, confirming coating properties.
Biocompatibility Testing (colorants)	Demonstrates biocompatibility of instrument colorants.	Successful completion, confirming biocompatibility.

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

Sample Size for Test Set: Not explicitly stated for any of the individual tests. The document refers to "worst case" testing for fatigue tests, implying a representative sample, but specific numbers are not given.
Data Provenance: The studies are primarily non-clinical tests (mechanical testing, cadaveric evaluation, material characterization). No patient data is mentioned in detail regarding provenance (country of origin, retrospective/prospective). The "Clinical Literature Review" would be based on existing published literature, which could involve diverse geographies and study types.

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

This question is not applicable as the studies described are mostly non-clinical engineering and material science tests. Ground truth in this context would refer to established engineering standards (e.g., ISO, ASTM, FDA guidance) and successful physical demonstration, rather than expert interpretation of medical images or patient outcomes. For the "Cadaveric evaluation," it can be inferred that medical professionals (likely surgeons) would be involved for the evaluation, but their number and specific qualifications are not mentioned.

4. Adjudication Method for the Test Set

This question is not applicable to the non-clinical tests described. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation or subjective assessments.

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 question is not applicable as the document describes a physical medical device, not an AI or software device involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by:

Recognized performance standards (e.g., ISO 21535, ISO 7206-10, ASTM F2009-00)
FDA guidance documents for specific tests (e.g., fatigue testing)
Material specifications and biocompatibility standards
Successful physical outcomes in laboratory and cadaveric settings.

8. The Sample Size for the Training Set

This question is not applicable as the document describes a physical medical device, not a machine learning model that requires a training set.

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

This question is not applicable for the same reason as above.

Summary

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JUN 3 0 2014

510(k) Summary

Sr. Regulatory Affairs Specialist

Exactech® Tapered Wedge Femoral Stem

Shing Jen Tai, PhD

Femoral Hip Stem

Phone: (352) 327-4638 Fax: (352) 378-2617

Company:	Exactech®, Inc
	2320 NW 66th Court
	Gainesville, FL 32653

June 30, 2014

Contact Person:

Date:

Proprietary Name:

Common Name:

Classification Names for Proposed Device:

Classification Names for Compatible Devices:

21 CFR 888.3353, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis; 21 CFR 888.3390, Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis;

21 CFR 888.3350, Hip joint metal/polymer semiconstrained cemented prosthesis 21 CFR 888.3358, Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis 21 CFR 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21 CFR 888.3310, Hip joint metal/polymer constrained cemented or uncemented prosthesis

Class II

Product Codes for Proposed Device:

LZO, MEH, KWY

Product Codes for Compatible Devices:

JDI, LPH, LWJ, KWZ

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Legally Marketed Device to Which Substantial Equivalence Is Claimed:

Accolade II Hip Stem (K 120578) from Howmedica Osteonics Corp. (a subsidiary ● of Stryker Corporation)
Taperloc Complete (K101086, and K103755 line extension to devices cleared in . · K101086) from Biomet Inc.
Novation 12/14 Press-Fit Femoral Stems (K042842) from Exactech Inc. .

Device Description

The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:

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 BioloxOption Femoral Heads and Adapters (K103012, . K121392)
. Exactech AcuMatch L-series Unipolar endoprosthesis (K010081)

The proposed femoral stems are intended to mate with the following bipolar components:

. Exactech AcuMatch L-Series Bipolar Endoprosthesis (K013211)
The Exactech Tapered Wedge Femoral Stem is accompanied by a complete instrumentation set including trial and broach/rasp system to assist surgeons in implantation of the device.

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Indications for Use

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.

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following device use and characteristics:

. Indications for Use. The proposed Exactech Tapered Wedge Femoral Stem and the predicate devices have same or similar indications for use.
Materials/Surface Finish/Coatings. The proposed Exactech Tapered Wedge . Femoral Stem and the predicate devices are composed of similar, biocompatible substrate materials, and the same or similar surface finish/coatings for permanent implants.
Design Features. The proposed Exactech Tapered Wedge Femoral Stem and the . predicate devices share similar design features.
Dimensions. The proposed Exactech Tapered Wedge Femoral Stem and the . predicate devices are dimensionally comparable.
Sterilization. The proposed Exactech Tapered Wedge Femoral Stem and the . predicate devices are provided sterile for single use only.
Performance Requirements. The proposed Exactech Tapered Wedge Femoral . Stem and the predicate devices conform to recognized performance standards for total hip replacement devices.

Non-Clinical Testing

The following clinical literature review, template studies, mechanical testing, and cadaveric evaluation were performed to demonstrate that the Exactech Tapered Wedge Femoral Stem performs as intended and is substantially equivalent to the identified predicate devices:

Clinical Literature Review of similar femoral prostheses. .
. Template Studies.
Range of Motion Testing per ISO 21535. .

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Distally Fixed Fatigue Testing of worst case per FDA guidance. .
Femoral Neck Fatigue Testing of worst case per FDA guidance. .
Femoral Head Modular Junction Burst Testing, Fatigue Testing, and Axial pull-. off Testing on Exactech taper specification per ISO 7206-10 and ASTM F2009-00.
. Cadaveric evaluation.
. Microstructural characterization and mechanical testing completed for the dual coating of the Exactech Tapered Wedge Femoral Stem.
Biocompatibility testing performed on the colorants used in production of . instruments.

Substantial Equivalence Conclusion

Based on consideration of indications for use, technological characteristics, and results of combined mechanical testing, cadaveric validation study, template studies, and clinical literature review described above, it was concluded that Exactech Tapered Wedge Femoral Stem demonstrates substantial equivalence to the referenced predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 30, 2014

Exactech Inc. Dr. Shing Jen Tai Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

Re: K140674

Trade/Device Name: Exactech® Tapered Wedge 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, MEH, KWY, LPH, JDI, LWJ, KWZ Dated: May 23, 2014 Received: May 27, 2014

Dear Dr. Tai:

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, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Shing Jen Tai

forth in the quality systems (QS) 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 yours,

Lori A. Wiggins

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 Statement

K140674 510(k) Number:

Device Name: Exactech® Tapered Wedge Femoral Stem

INDICATIONS 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.

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.

Prescription Use X and/or (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic 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.