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.

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device's performance that can be presented in a table or a study proving that a device meets such criteria.

The document is a Special 510(k) Summary of Safety and Effectiveness for the Exactech Ziramic™ Zirconia 12/14 Femoral Heads. It focuses on demonstrating substantial equivalence to a previously marketed predicate device (#K050398) rather than presenting a study against pre-defined acceptance criteria for device performance.

Here's what can be extracted from the document regarding the "study" mentioned, which is more accurately described as "testing and engineering evaluations" for substantial equivalence:

1. A table of acceptance criteria and the reported device performance: Not available. The document states: "Testing and engineering evaluations were conducted to verify adequate performance of the Exactech® Ziramic™ Zirconia 12/14 Femoral Heads for anticipated in vivo loading when mated with Exactech cobalt chrome alloy 12/14 Femoral Stems." It doesn't provide specific quantitative acceptance criteria or detailed performance results in the summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available. The document mentions "testing and engineering evaluations" without specifying sample sizes or the nature of the data (e.g., in vitro, in vivo, etc.).
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. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical trials), not for engineering evaluations of a hip femoral head.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for engineering evaluations.
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 is for AI/human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for engineering evaluations of medical devices typically involves physical and mechanical properties being measured against established standards or performance expectations for the device's intended use. The document generally refers to "anticipated in vivo loading" as the context for performance.
8. The sample size for the training set: Not applicable. No "training set" in the context of an AI/machine learning model is mentioned.
9. How the ground truth for the training set was established: Not applicable.

Summary

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KO60 O Page Viz

Exactech® Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) -Summary of Safety and Effectiveness

Exactech® Inc.
2320 N.W. 66ª Court Sponsor: Gainesville, Florida 32653

Phone: (352) - 377 - 1140 Fax: (352) - 378 - 2617

FDA Establishment Number 1038671

Contact: Maritza Elias Regulatory Representative

February 2, 2006 Date:

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Exactech® Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) -Summary of Safety and Effectiveness

Trade / Proprietary Name:	Exactech ®
Model Name:	Ziramic™ Zirconia 12/14 Femoral Head
Classification Name:	Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cementedor Non-Porous, Uncemented
Product Code:	LZO, LPH
C.F.R. Section:	21 CFR 888.3353, 21 CFR 888.3358
Device Class:	II
Classification Panel:	Orthopedic

Legally Marketed Devices for Substantial Equivalence Comparison:

Exactech® Ziramic™ Zirconia 12/14 Femoral Head

Device Description:

INDICATIONS

#K050398

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Exactech® Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) -Summary of Safety and Effectiveness

CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.

The Zirconia Ceramic Head is contraindicated for use with any other acetabular cup liner than an ultra high molecular weight polyethylene (UHMWPE) liner or a metal backed UHMWPE liner.

The safety and effectiveness has not been shown for the use of Exactech stems when used with ceramic on ceramic acetabular cups.

Special 510(k) Modifications

The Exactech® Ziramic™ Zirconia 12/14 Femoral Heads were modified from the predicate as follows:

The mating parts scope was expanded to include: . Exactech® AcuMatch® 12/14 Cemented Femoral Stems Exactech® Novation™ 12/14 Cemented Femoral Stems
. The package insert was updated to clarify femoral head and femoral stem compatibility

Conclusion:

Testing and engineering evaluations were conducted to verify adequate performance of the Exactech® Ziramic™ Zirconia 12/14 Femoral Heads for anticipated in vivo loading when mated with Exactech cobalt chrome alloy 12/14 Femoral Stems. Based on successful results we conclude that the proposed 12/14 Ziramic™ Zirconia 12/14 Femoral Heads devices are substantially equivalent to the predicate design (#K050398).

rev. 12/14/05

Section 4 Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

2006 FEB &

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maritza Elias Regulatory Representative Exactech Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K060107

Trade/Device Name: Ziramic™ Zirconia 12/14 Femoral Head Regulation Number: 21 CFR 888.3353 Regulation Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented Regulatory Class: II Product Codes: LZO, LPH Dated: December 16, 2005 Received: January 13, 2006

Dear Ms. Elias:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 -- Ms. Maritza Elias

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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. production will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark H. Milliken

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech®, Inc. Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) - Indication for Use

KOGO107 510(k) Number:

INDICATIONS

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.

CONTRAINDICATIONS

The Zirconia Ceramic Head is contraindicated for use with any other acetabular cup liner than an ultra high molecular weight polyethylene (UHMWPE) liner or a metal backed UHMWPE liner.

The safety and effectiveness has not been shown for the use of Exactech stems when used with ceramic on ceramic acetabular cups.

Prescription Use	X	or	Over the Counter Use
------------------	---	----	----------------------

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative, on S-Off) and Neurological Devices	Division of General, Restorative and Neurological Devices
510(k) Number	K060107
Number

Section 3

Page 1 of 1

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.