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.

Device Description

The proposed Exactech Novation Tapered 12/14 Press-Fit Femoral Stems are a modification of the Exactech Novation 12/14 Press-Fit Femoral Stems cleared through premarket notification #K042842.
The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.
The modified devices share the following similarities with predicate devices:

The same indications for use
The same design features (e.g. neck and stem geometry, femoral head taper . design, stem insertion feature, offsets - standard and extended)
The same materials (titanium alloy, commercially pure titanium plasma spray) .
The same shelf life (5 years), and .
Are packaged and sterilized using the same materials and processes (gamma ● radiation sterilization to a sterility assurance level (SAL) of 100).
This submission proposed the following design changes:
A change to the sizing range and increments between additional femoral stem . sizes
A heat treatment change for the additional femoral stem sizes only .

AI/ML Overview

The provided document describes a Special 510(k) submission for the Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems. This type of submission is used for modifications to a manufacturer's own legally marketed device (predicate device) where the proposed changes do not "affect the fundamental scientific technology of the device" and "do not raise different questions of safety and effectiveness."

Therefore, the submission does not involve a study to meet new acceptance criteria in the traditional sense of a clinical trial or algorithm performance validation. Instead, the "acceptance criteria" are demonstrating substantial equivalence to the predicate device through engineering analyses.

Here's an analysis of the provided text based on your request, highlighting why many sections are not applicable to this type of submission:

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

Acceptance Criteria (Demonstrated Equivalence)	Reported Device Performance
Geometric features of the proposed device correspond to the anatomical features of the femur.	An engineering evaluation was conducted that determined "the geometric features of the proposed device correspond to the anatomical features of the femur." This suggests the modifications (sizing range and increments) maintain appropriate anatomical fit.
The proposed device has fatigue strength equivalent to other comparable legally marketed femoral stems (specifically, the predicate device).	An engineering evaluation was conducted that determined "the proposed device has fatigue strength equivalent to other comparable legally marketed femoral stems." This indicates the heat treatment change for new sizes did not compromise the fatigue strength compared to the predicate.

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

Not applicable. This submission relies on engineering analyses and comparisons to a predicate device, not a test set of 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)

Not applicable. No ground truth was established by experts for a test set of data. The evaluation was based on engineering principles and comparisons.

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

Not applicable. No test set was used requiring adjudication.

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 not an AI-assisted device and no MRMC study was conducted.

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

Not applicable. This is a medical implant, not an algorithm.

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

Not applicable in the context of a "ground truth" for a dataset. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the modifications are compared through engineering analysis.

8. The sample size for the training set

Not applicable. This is a medical implant, not a machine learning model, so there is no training set.

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

Not applicable. There is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" proving the device meets the acceptance criteria (which, in this context, is substantial equivalence to the predicate device) consisted of engineering analyses.

Engineering Evaluation for Geometric Features: This evaluation determined that the geometric features of the proposed device (with its new sizing range and increments) correspond appropriately to the anatomical features of the femur. This is crucial for proper fit and function.
Engineering Evaluation for Fatigue Strength: This evaluation determined that the proposed device (which includes a heat treatment change for the additional stem sizes) possesses fatigue strength equivalent to the predicate device and other comparable legally marketed femoral stems. Maintaining equivalent fatigue strength is critical for the long-term durability and safety of the implant, preventing premature failure.

The results of these engineering analyses were deemed sufficient by the FDA to demonstrate substantial equivalence to the predicate device (Exactech Novation 12/14 Press-Fit Femoral Stems, K042842). This conclusion is based on the premise that the proposed changes (sizing and heat treatment for new sizes) do not alter the fundamental scientific technology or raise new safety/effectiveness questions that would require comprehensive clinical data.

Summary

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Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness

NOV. - 8 2010.

Sponsor:

Exactech® Inc. 2320 N.W. 66th Court Gainesville, FL 32653

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

FDA Establishment Number 1038671

(102-487

Vladislava Zaitseva Contact: Regulatory Affairs Specialist

Date: October 12, 2010

Trade or Proprietary or Model Name(s):

Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems

Common Name:

Press-Fit Femoral Stem component

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)
Prosthesis, hip, semi-constrained, metal/polymer, uncemented. (CFR 888.3360 . Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Class II, Product Code LWJ)
Prosthesis, hip, semi-constrained, metal/polymer, cemented. (CFR 888.3350. Hip joint metal/polymer semi-constrained cemented prosthesis Class II, Product Code JDI)

Information on devices to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary or Model Name · Manufacturer

K042842 Novation 12/14 Press-Fit Femoral Stems Exactech, Inc

Indications for Use:

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102487

p.2/2

Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness

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 Exactech Novation Tapered 12/14 Press-Fit Femoral Stems are a modification of the Exactech Novation 12/14 Press-Fit Femoral Stems cleared through premarket notification #K042842.

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

The modified devices share the following similarities with predicate devices:

The same indications for use
The same design features (e.g. neck and stem geometry, femoral head taper . design, stem insertion feature, offsets - standard and extended)
The same materials (titanium alloy, commercially pure titanium plasma spray) .
The same shelf life (5 years), and .
Are packaged and sterilized using the same materials and processes (gamma ● radiation sterilization to a sterility assurance level (SAL) of 100).

This submission proposed the following design changes:

A change to the sizing range and increments between additional femoral stem . sizes
A heat treatment change for the additional femoral stem sizes only .

Substantial Equivalence Conclusion:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Novation Tapered 12/14 Press-Fit Femoral Stems:

An engineering evaluation to determine that the geometric features of the ♥ proposed device correspond to the anatomical features of the femur.
An engineering evaluation to determine that the proposed device has fatigue . strength equivalent to other comparable legally marketed femoral stems.

The results demonstrate that the proposed device is a substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion 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 Northwest 66th Court Gainesville, Florida 32653

NOV - 8 2010

Re: K102487

Trade/Device Name: Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems 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, JDI, LWJ Dated: October 12, 2010 Received: October 15, 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, Or R 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 contractly and warranties. We remind you, however, that device labeling must be truthful and not maching.

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 davice (1 https 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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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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Сваване вмет

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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K102487

Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems Special 510(k) - Indications for Use

510(k) Number:

NOV: -- 8} 2010 :

ﻴﺔ

Device Name: Exactech® Novation® Tapered 12/14 Press-Fit Femoral Stems

INDICATIONS

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 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)

K102487 Barbara Buend

(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K102487

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.