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. . Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon
. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Description

The proposed Novation Crown Cup with InteGrip acetabular shells are modifications to the Novation Crown Cup Acetabular Shell, Cluster Hole, Plasma Coated devices cleared through premarket notification #K070479, Novation Crown Cup and Liners.

The predicate and proposed devices have the same intended use and basic fundamental scientific technology.

The modified devices share the following similarities with the predicate devices:

Indications for use
. Design features (e.g., outer and inner geometries, constrained liner feature, apical locking feature , anti-rotational feature, and product scope)
. Material (titanium alloy)
Shelf life (5 years) ●
. Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°).

This submission proposes the following design change:

The proposed device will have a porous surface and will be manufactured from titanium alloy per ISO 5832-3 using an additive manufacturing process. The same material surface/coating was previously cleared for porous uncemented use in the hip in 510(k) K101761 - Exactech Novation Empire Acetabular Augments with InteGrip.

AI/ML Overview

This 510(k) summary describes a modification to an existing device, the Exactech® Novation® Crown Cup® with InteGrip™ Acetabular Shell. The submission focuses on demonstrating substantial equivalence to a predicate device by evaluating a design change (porous surface manufacturing process) through engineering analyses and an animal study.

Here's an analysis of the provided information against your requested criteria:

Acceptance Criteria and Device Performance

Acceptance Criteria / Test Performed	Reported Device Performance / Evaluation Method
Abrasion resistance (ASTM F1978-07)	Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence).
Shear fatigue strength (ASTM F1160-50)	Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence).
Static shear strength (ASTM F1044-08)	Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence).
Static tensile strength (ASTM F1147-05)	Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence).
Compressive deformation testing	Conducted to evaluate the integrity of the porous surface/coating. (Specific results not detailed in the summary, but stated to demonstrate substantial equivalence).
Volume % porosity (ASTM F1854-01)	Testing performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 for a porous-coated uncemented hip prosthesis. (Specific results not detailed in the summary, but stated to meet specifications).
Pore size (ASTM F1854-01)	Testing performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 for a porous-coated uncemented hip prosthesis. (Specific results not detailed in the summary, but stated to meet specifications).
Thickness (ASTM F1854-01)	Testing performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 for a porous-coated uncemented hip prosthesis. (Specific results not detailed in the summary, but stated to meet specifications).
Interconnected porosity	Testing performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 for a porous-coated uncemented hip prosthesis. (Specific results not detailed in the summary, but stated to meet specifications).
Biological fixation	12-week ovine animal study conducted to indicate that stable fixation occurs via biological fixation and is comparable to predicate devices. (No specific quantitative results are provided in this summary, but the study conclusion is that it is "comparable"). These engineering analyses were originally provided and reviewed in premarket notification K101761 - Exactech Novation Empire Acetabular Augments with InteGrip. The results of engineering analyses demonstrate the proposed device is substantially equivalent to the predicate device.

Study Details for Demonstrating Substantial Equivalence:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set (for physical/material testing): Not explicitly stated as a "test set" in the traditional sense of clinical data. The tests are engineering analyses performed on samples of the device or its components. The number of samples for each specific test (e.g., how many cups were tested for abrasion resistance) is not provided.
- Test Set (for animal study): The study was a "12-week ovine animal study." The number of animals used is not specified.
- Data Provenance: Not specified for the engineering tests or animal study. It is likely that these tests were conducted by or for Exactech, Inc. in Gainesville, Florida, USA, given the sponsor information. The data appears to be prospective in the context of generating data for this 510(k) submission, although the summary notes that these analyses were "originally provided and reviewed in premarket notification K101761."
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 submission does not involve human expert review of clinical data for establishing ground truth. The "ground truth" for the material properties is defined by industry standards (ASTM) and FDA regulations (21 CFR 888.3358). For the animal study, the assessment of biological fixation would be performed by veterinary researchers/pathologists, but their number and specific qualifications are not detailed in this summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert opinions on clinical cases. The "adjudication" of the engineering tests comes from meeting predetermined pass/fail criteria based on ASTM standards and regulatory specifications. For the animal study, the determination of biological fixation would be based on scientific observation and analysis protocols.
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:
- No MRMC comparative effectiveness study was done. This 510(k) pertains to a medical device (hip prosthesis), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Material Properties: The ground truth is defined by industry standards (ASTM) and regulatory specifications (21 CFR 888.3358) regarding porosity, pore size, thickness, and mechanical strength properties of porous-coated uncemented hip prostheses.
- For Biological Fixation: The ground truth is established through histological and potentially radiographic evaluation in the ovine animal model, aiming to demonstrate biological ingrowth and stable fixation, consistent with the accepted understanding of biological fixation for uncemented implants.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable. There is no training set for this device submission.

Summary

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Exactech® Novation® Crown Cup® with InteGrip™ Special 510(k) - 510(k) Summary of Safety and Effectiveness

NOV - 5 2010

(102975

Sponsor:	Exactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653
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Phone: (352) 377-1140 Fax: (352) 378-2617

FDA Establishment Number 1038671

Contact: Vladislava Zaitseva Regulatory Affairs Specialist
Date: November 5, 2010

Trade of Proprietary or Model Name(s):

Exactech® Novation® Crown Cup® with InteGrip™ Acetabular Shell

Common Name:

Total Hip Arthroplasty - Acetabular Components

Classification Name:

21 CFR 888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. Class II. Product Code: LPH - prosthesis, hip, semiconstrained, metal/polymer, porous, uncemented.

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade of Proprietary Model Name	Manufacturer
K070479	Novation® Crown Cup™ and Liners	Exactech, Inc

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. . Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon

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Exactech® Novation® Crown Cup® with InteGrip™ Special 510(k) - 510(k) Summary of Safety and Effectiveness

. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Description:

The predicate and proposed devices have the same intended use and basic fundamental scientific technology.

The modified devices share the following similarities with the predicate devices:

Indications for use
. Design features (e.g., outer and inner geometries, constrained liner feature, apical locking feature , anti-rotational feature, and product scope)
. Material (titanium alloy)
Shelf life (5 years) ●
. Packaging and sterilization materials and processes (gamma radiation sterilization to a sterility assurance level of 10°).

This submission proposes the following design change:

Substantial Equivalence Conclusion:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Novation Crown Cup acetabular shells:

Abrasion resistance (ASTM F1978-07), shear fatigue strength (ASTM F1160-50), . static shear strength (ASTM F1044-08), static tensile strength (ASTM F1147-05) and compressive deformation testing was conducted to evaluate the integrity of the porous surface/coating.
. Testing was performed to demonstrate the porous surface/coating met the specifications of 21 CFR 888.3358 (i.e., volume % porosity [ASTM F1854-01]. pore size [ASTM F1854-01], thickness (ASTM F1854-01], interconnected porosity) for a porous-coated uncemented hip prosthesis.
. A 12-week ovine animal study to indicate that stable fixation occurs via biological fixation and is comparable to predicate devices.

These engineering analyses were originally provided and reviewed in premarket notification K101761 - Exactech Novation Empire Acetabular Augments with InteGrip. The results of engineering analyses demonstrate the proposed device is . substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Exactech, Inc. % Ms. Vladislava Zaitseva Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653

NOV - 5 2010

Re: K102975

Trade/Device Name: Exactech Novation Crown Cup with InteGrip Acetabular Shell Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Codes: LPH, JDI, KWZ, LZO Dated: October 5, 2010 Received: October 6, 2010

Dear Ms. Zaitseva:

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

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Page 2 - Ms. Vladislava Zaitseva

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark M. Milleson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech® Novation® Crown Cup® with InteGrip" Special 510(k) - Indications for Use

510(k) Number: K102975

NOV - 5 2010

Device Name: Exactech® Novation® Crown Cup® with InteGrip™ Acetabular Shell

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.

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. . Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon
. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

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

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)

Oputu for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102975

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.