NOVATION CFS PRESS-FIT AND CEMENTED STEMS

{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: 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 {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 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. ### 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.