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 Novation CFS Press-Fit and Cemented Femoral Stems are modifications to the existing Novation Press-Fit and Novation Cemented Plus femoral stem devices previously cleared in K042842 and K083392, respectively. The proposed Novation CFS Press-Fit stem has the same general design features as the predicate device. The modifications include the addition of a calcar collar, grit-blast body, and a satin finish neck. The proposed CFS Cemented stem has the same general design features as the Novation Cemented Plus stem, but the proposed stems are cast instead of forged cobalt chrome alloy and the neck is a satin finish. Both proposed stems contain a modified 12/14 femoral head taper connection.
The proposed stems mate with previously cleared 12/14 Co-28Cr-6Mo femoral heads (K041906), Zirconia ceramic femoral heads (K050398 and K060107) and 12/14 Unipolar Sleeves (K010081). The proposed stems are not compatible with alumina ceramic femoral heads (K032964 and K051682).
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
· the same indications for use
· similar design features
· incorporate the same materials
· the same shelf life
· are packaged and sterilized using the same materials and processes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is not present as this document is a 510(k) summary for a medical device (femoral stems) and not a study on an AI/ML device:

Important Note: The provided document is a 510(k) Summary for a physical medical device (femoral stems), not an AI/ML device. Therefore, the questions regarding AI/ML performance, sample sizes for training/test sets, expert ground truth, MRMC studies, and standalone algorithm performance are not applicable to this document. The "study" mentioned refers to engineering studies to demonstrate substantial equivalence, not clinical or AI/ML performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from 510(k) Summary)	Reported Device Performance (from 510(k) Summary)
Substantial Equivalence: Maintain same intended use, basic fundamental scientific technology, indications for use, similar design features, incorporate the same materials, same shelf life, packaged and sterilized using the same materials and processes as predicate devices (K042842 and K083392).	Substantially Equivalent: "Results of engineering studies referenced in this 510(k) submission demonstrate that the proposed Novation CFS Press-Fit and Cemented Femoral Stems are substantially equivalent to the cleared predicate devices."

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

Not Applicable. This document describes a physical medical device. The "test set" in the context of this 510(k) refers to the modified femoral stems themselves undergoing engineering studies (e.g., mechanical testing), not a dataset for an AI/ML algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective clinical data) in the context of an AI/ML test set.

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

Not Applicable. Ground truth, in the context of AI/ML, involves expert labeling of data. This document pertains to physical device design and engineering validation, not AI/ML.

4. Adjudication Method for the Test Set

Not Applicable. This refers to AI/ML ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not Applicable. This is specific to AI/ML devices assessing reader performance. The document describes a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is specific to AI/ML devices. The document describes a physical medical device.

7. The Type of Ground Truth Used

Not Applicable. For a physical device like a femoral stem, the "ground truth" relates to material properties, mechanical integrity, and biological compatibility, which are assessed through engineering analyses, material testing, and preclinical/clinical data if required (though for a 510(k), often relies on equivalence to predicates) rather than expert consensus on data labels, pathology, or outcomes data in the AI/ML sense.

8. The Sample Size for the Training Set

Not Applicable. This implies an AI/ML algorithm. The document concerns a physical device.

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

Not Applicable. This implies an AI/ML algorithm. The document concerns a physical device.

Summary of Device and Evidence Presented in Document:

The document is a 510(k) summary for new Exactech® Novation® CFS™ Press-Fit and Cemented Femoral Stems. The "study" mentioned refers to engineering studies comparing these modified stems to previously cleared predicate devices (Novation® 12/14 Press-Fit Femoral Stems K042842 and Novation® Cemented Plus Femoral Stems K083392).

The primary acceptance criterion is substantial equivalence to the predicate devices. The device meets this by demonstrating, through engineering studies, that it has:

The same intended use
Basic fundamental scientific technology
Same indications for use
Similar design features (with specified modifications like calcar collar, grit-blast body, satin finish neck, and cast vs. forged material for cemented stems)
Incorporates the same materials (except for the casting change)
The same shelf life
Packaged and sterilized using the same materials and processes.

The FDA reviewed the submission and concurred that the device is substantially equivalent to legally marketed predicate devices. The specific details of the "engineering studies" (e.g., number of tests, specific parameters measured, statistical analysis) are not provided in this public summary but would have been part of the full 510(k) submission.

Summary

{0}------------------------------------------------

Exactech® Novation® CFS™ Press-Fit and Cemented Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness

APR 2 1 2009

Exactech® İnc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653

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

FDA Establishment Number 1038671

Tara R. Patterson Contact: Associate Regulatory Affairs Specialist
March 18, 2008 Date:

Trade or Proprietary or Model Name(s): Exactech® Novation® CFS™ Press-Fit and Cemented Femoral Stems

Common Name: Cemented Femoral Hip Prosthesis

Press-Fit Femoral Hip Prosthesis

Classification Name:

Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Prosthesis, hip, semi-constrained, metal/polymer, cemented

Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

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.
K083392	Novation® Cemented Plus Femoral Stems	Exactech, Inc.

Indications for Use:

{1}------------------------------------------------

K090764 (pg 2/2)

Exactech® Novation® CFSTM Press-Fit and Cemented Femoral Stems Special 510(k) - 510(k) Summary of Safety and Effectiveness

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 stems mate with previously cleared 12/14 Co-28Cr-6Mo femoral heads (K041906), Zirconia ceramic femoral heads (K050398 and K060107) and 12/14 Unipolar Sleeves (K010081). The proposed stems are not compatible with alumina ceramic femoral heads (K032964 and K051682).

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:

· the same indications for use
· similar design features
· incorporate the same materials
· the same shelf life
· are packaged and sterilized using the same materials and processes.

Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate that the proposed Novation CFS Press-Fit and Cemented Femoral Stems are substantially equivalent to the cleared predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2009

Exactech® Inc. % Ms. Tara R. Patterson Associate Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, FL 32653

Re: K090764

Trade/Device Name: Novation CFS Press-Fit and Cemented Stems Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: LWJ, LZO, JDI Dated: March 19, 2009 Received: March 23, 2009

Dear Ms. Patterson:

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 16 ass starterior 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 I ou may, attrefy missions of the Act include requirements for annual registration, listing 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 If your dovied 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 r lease be actived that i Driver in that your device complies with other requirements of the Act that + Dr has intatutes and regulations administered by other Federal agencies. You must or any I occur 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 Of K F art 607), accember (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at 240-276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

f.o.L Peter D. R.

Mark N. Melkerson Dep DIRECTOR
Director

MD 09/21/15

Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Exactech® Novation® CFSTM Press-Fit and Cemented Femoral Stems Special 510(k) - Indications for Use

510(k) Number:

K090764(pg1/1)

Device Name: Exactech® Novation® CFS™ Press-Fit and Cemented Femoral Stems

INDICATIONS

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.

t 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.

Image /page/4/Picture/13 description: The image shows a document with the title "Concurrence of CDRH, Office of Device Evaluation (ODE)". There is a signature above the text "(Division Sign-Off)". Below this is the text "Division of General, Restorative, and Neurological Devices". The 510(k) number is K090764.

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.