(59 days)
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No
The summary describes a mechanical implant (femoral stem) and its material properties and testing, with no mention of AI/ML in its design, function, or intended use.
No
A therapeutic device is used to treat or cure a disease or condition. This device is an implant for hip replacement, which is a treatment, making it a therapeutic device.
No
Explanation: This document describes a femoral stem implant, which is a prosthetic device used in hip replacement surgery. It is not used for diagnosing medical conditions but rather for treatment.
No
The device description clearly states it is a physical implant (femoral stem) made of Cobalt Chromium Alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a femoral stem implant used in hip replacement surgery. This is a surgically implanted device, not a device used for testing samples outside the body.
- Lack of Diagnostic Function: The device's purpose is to replace a damaged part of the hip joint, not to diagnose a condition or provide information about a patient's health through testing of biological samples.
Therefore, based on the provided information, the Exactech® Alteon® Highly Polished Femoral Stem is a surgical implant, not an In Vitro Diagnostic device.
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 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 stock is present, and to restore mobility resulting from previous fusion.
Exactech® Highly Polished Femoral Stems are intended for cemented fixation.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LWJ, KWL, KWZ, KWY
Device Description
The Exactech® Alteon® Highly Polished Femoral Stem implants are manufactured from forged Cobalt Chromium Alloy (Co-28Cr-6Mo) with a polished neck finish and polished surface finish. The Alteon® Highly Polished Femoral Stems are available in different combinations of stem length, neck offset, and diameter to accommodate an array of patient anatomies. The femoral stem has a 12/14 taper and has a trapezoidal cross-sectional stem geometry with a distal taper.
Alteon® Highly Polished Femoral Stem implants are collarless femoral stems and are intended for cemented use only.
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)
Non-Clinical Testing:
- Distal Fatigue Testing
- Proximal Fatigue Testing
- Range of Motion Analysis
- Femoral Head Compatibility Testing including; burst testing, fatigue testing, post-fatigue burst testing, and pull-off
- Geometry Comparison of Alteon® HPS to Alteon® HA Femoral Stem
- Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Exactech® Alteon® Highly Polished Femoral Stems meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
November 8, 2018
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Exactech®, Inc. Zach Sharrah Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K182462
Trade/Device Name: Exactech® Alteon® Highly Polished 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: LZO, LWJ, KWL, KWZ, KWY Dated: September 7, 2018 Received: September 10, 2018
Dear Zach Sharrah:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Daniel S. Ramsey -S 2018.11.08 17:31:06 -05'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182462
Device Name
Exactech® Alteon® Highly Polished 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 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 stock is present, and to restore mobility resulting from previous fusion.
Exactech® Highly Polished Femoral Stems are intended for cemented fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Exactech® Alteon® Highly Polished Femoral Stem 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: | September 7, 2018 |
| Contact Person: | Zach Sharrah
Sr. Regulatory Affairs Specialist
Telephone: (352) 327-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Alteon® Highly Polished Femoral Stem |
| Common Name: | Femoral Hip Stem |
| Classification Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or
non-porous uncemented prosthesis (21 CFR 888.3353, Class II,
Product Code: LZO) |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis (21 CFR 888.3360, Class II, Product Code: LWJ) |
| | Hip joint femoral (hemi-hip) metallic cemented or uncemented
prosthesis (21 CFR 888.3360, Class II, Product Code: KWL) |
| | Hip joint metal/polymer constrained cemented or uncemented
prosthesis (21 CFR 888.3310, Class II, Product Code: KWZ) |
| | Hip joint femoral (hemi-hip) metal/polymer cemented or
uncemented prosthesis (21 CFR 888.3390, Class II,
Product Code: KWY) |
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Avenir Cemented Hip Stem | Zimmer | K131884 |
4
Exactech® Alteon® Highly Polished Femoral Stem Traditional 510(k) - 510(k) Summarv
Indication 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 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® Highly Polished Femoral Stems are intended for cemented fixation.
Device Description:
The Exactech® Alteon® Highly Polished Femoral Stem implants are manufactured from forged Cobalt Chromium Alloy (Co-28Cr-6Mo) with a polished neck finish and polished surface finish. The Alteon® Highly Polished Femoral Stems are available in different combinations of stem length, neck offset, and diameter to accommodate an array of patient anatomies. The femoral stem has a 12/14 taper and has a trapezoidal cross-sectional stem geometry with a distal taper.
Alteon® Highly Polished Femoral Stem implants are collarless femoral stems and are intended for cemented use only.
Summary of Technological Characteristics:
The rationale for substantial equivalence of the proposed Exactech® Alteon® Highly Polished Femoral Stems to the predicate and reference devices is based on consideration of the following device use and characteristics:
- · Indications for Use. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device have similar Indications for Use statements. Both proposed and predicate device are indicated for osteoarthritis, rheumatic diseases, post-traumatic degenerative problems, and revision of failed previous reconstructions. Both proposed and predicate device are indicated for hemi or total hip arthroplasty.
- · Materials/Surface Finish/Coatings, Like the predicate device, the proposed Exactech® Alteon® Highly Polished Femoral Stem is a metallic implant with a highly polished surface finish for permanent implantation at the same site of the body.
· Design Features. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device share the same design features; 12/14 taper geometry, neck axis, standard and extended offsets, and offered in a collarless design.
- · Dimensions. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device have similar neck offset and stem length dimensions.
· Sterilization. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device are provided sterile for single use only.
· Performance Requirements. The proposed Exactech® Alteon® Highly Polished Femoral Stem and the predicate device conform to recognized performance standards for total hip replacement devices.
5
Exactech® Alteon® Highly Polished Femoral Stem Traditional 510(k) - 510(k) Summarv
Non-Clinical Testing:
The following non-clinical testing has been performed to demonstrate that the Exactech® Alteon® Highly Polished Femoral Stems perform as intended and are substantially equivalent to the identified predicate devices:
- Distal Fatigue Testing ●
- Proximal Fatigue Testing
- Range of Motion Analysis
- o Femoral Head Compatibility Testing including; burst testing, fatigue testing, post-fatigue burst testing, and pull-off
- · Geometry Comparison of Alteon® HPS to Alteon® HA Femoral
Stem
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Exactech® Alteon® Highly Polished Femoral Stems 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:
Based on consideration of Indications for Use, technological characteristics, and results of nonclinical testing referenced in this submission. it is concluded that the proposed Exactech® Alteon® Highly Polished Femoral Stems are substantially equivalent to the cited cleared predicate devices.