(209 days)
Not Found
No
The document describes a mechanical implant and its testing, with no mention of AI or ML technology.
Yes
The device is indicated for conditions such as osteoarthritis and rheumatoid arthritis, which are diseases, and aims to restore mobility and treat fractures, indicating its use in treating, mitigating, or preventing disease, or affecting the structure or function of the body.
No
The device description clearly states it is a femoral stem for hip replacement surgery, falling under the category of orthopedic implants for treatment, not diagnosis. The "Intended Use" section lists various conditions for which hip replacement is indicated, implying the device is a therapeutic intervention based on a prior diagnosis.
No
The device description clearly indicates it is a physical implant (femoral stem) made of Ti-6A1-4V with specific geometric features and coatings, intended for surgical implantation. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical implantation in the hip for various conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (femoral stem) made of metal, designed for surgical insertion.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on mechanical properties and sterility, which are relevant for an implantable device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body for treatment.
N/A
Intended Use / 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 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.
Exactech Alteon HA femoral stems are intended for press-fit fixation.
Product codes
MEH
Device Description
The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V with a polished neck region, grit blast surface and HA coating on the stem body. The stem has a 12/14 taper. The Alteon HA Femoral Stems Femoral Stems are available in various lengths with standard and extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.
The Alteon HA Femoral Stems are intended for press-fit applications and are not intended for use with bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An engineering analysis was conducted to evaluate the mechanical properties of the proposed Alteon HA Femoral Stems, including:
- Distal Fatigue Testing
- Proximal Fatigue Testing
- Range of Motion Analysis
Pyrogen testing was conducted in accordance with USP . USP . and ANSVAAMI ST72 to meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Exactech Alteon HA Femoral Stems are substantially equivalent to the cleared Exactech Novation Element Press-Fit Femoral Stem.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending downward from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2017
Exactech, Inc. Thomas McNamara, RAC Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K162732 Trade/Device Name: Exactech® Alteon® HA Femoral Stem 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: MEH Dated: February 27, 2017 Received: March 1, 2017
Dear Mr. McNamara:
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. Isting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
p.1/1
Device Name
Exactech® Alteon® HA Femoral Stem
Indications for Use (Describe)
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.
Exactech Alteon HA femoral stems are intended for press-fit fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Exactech® Alteon® HA Femoral Stems Traditional 510(k) - 510(k) Summary
| Sponsor: | Exactech®, Inc
2320 NW 66th Court
Gainesville FL, 32653 |
|-------------------|-----------------------------------------------------------------------------------------------------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Date: | April 25, 2017 |
| Contact Person: | Thomas McNamara, RAC
Regulatory Affairs Specialist
Telephone: (352) 327-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Alteon® HA Femoral Stems |
| Common Name: | Femoral Stem |
Classification Name:
Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis, 21 CFR 888.3353, Class II, Product Code MEH
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Exactech Novation Element Press- | ||
| Fit Femoral Stem | Exactech, Inc | K153649 |
Indication for Use:
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.
Exactech Alteon HA femoral stems are intended for press-fit fixation.
Device Description
The Exactech Alteon HA Femoral Stems are manufactured from Ti-6A1-4V with a polished neck region, grit blast surface and HA coating on the stem body. The stem has a 12/14 taper. The Alteon HA Femoral Stems Femoral Stems are available in various lengths with standard and
4
Exactech® Alteon® HA Femoral Stems Traditional 510(k) - 510(k) Summary
extended neck offset configurations, and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.
The Alteon HA Femoral Stems are intended for press-fit applications and are not intended for use with bone cement.
Testing:
An engineering analysis was conducted to evaluate the mechanical properties of the proposed Alteon HA Femoral Stems, including:
- Distal Fatigue Testing ●
- Proximal Fatigue Testing ●
- Range of Motion Analysis ●
Pyrogen testing was conducted in accordance with USP . USP . and ANSVAAMI ST72 to meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Exactech Alteon HA Femoral Stems are substantially equivalent to the cleared Exactech Novation Element Press-Fit Femoral Stem.