(378 days)
No
The summary describes a mechanical hip implant and its testing, with no mention of AI/ML technology.
Yes.
The device is a component of an Exactech Hip System, which is indicated for use in hip replacement due to various medical conditions, serving to treat and restore function.
No
Explanation: This device is a medical implant (femoral stem component for hip replacement) and not a tool used to diagnose medical conditions. Its purpose is to treat conditions like osteoarthritis or proximal femoral fractures.
No
The device description clearly describes a physical implant (femoral stem component) made of titanium alloy, not software.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Exactech Hip Systems and the Alteon Short Tapered Wedge are implants used in surgical procedures for hip replacement. They are physical components inserted into the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its purpose is to replace a damaged hip joint.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
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 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.
- · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Product codes (comma separated list FDA assigned to the subject device)
LZO, MEH, JDI, KWY, KWZ, LPH, LWJ
Device Description
The Exactech Alteon Short Tapered Wedge is a collarless, press-fit femoral stem component to be used in total or hemi hip arthroplasty, and is designed to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal.
The Alteon Short Tapered Wedge has seventeen size offerings and two lateral offsets per size. It is made from titanium alloy and includes a 12/14 trunnion, a polished neck region, a commercially pure titanium plasma spray coated press-fit region, and a bead-blasted (satin) distal surface finish. The 12/14 trumion allows for compatible connection with Exactech femoral heads. As a line extension to the predicate, the proposed Alteon Short Tapered Wedge differs from the predicate in that it features a shortened distal stem length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femoral/medullary canal
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:
- Distally Fixed Fatigue testing (ISO 7206-4 and ASTM F2068)
- Femoral Neck Proximal Fatigue testing (ISO 7206-6 and ASTM F2068)
- Femoral Head Modular junction burst testing, fatigue testing, and pull-off (ISO 7206-10 and ASTM F2009)
- Coating characterization (ASTM F1854)
- Range of Motion analysis (ISO 21535)
- Template Studies
- Cadaveric Evaluation (BS EN 62366-1:2015+A1:2020)
Results: Based on consideration of indications for use, technological characteristics, and results of non-clinical testing, it was concluded that the Exactech Alteon Tapered Wedge femoral stems demonstrate substantial equivalence to the referenced predicate devices.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 19, 2023
Exactech, Inc Valdimir Talley III Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K221323
Trade/Device Name: Exactech® Alteon® Short Tapered Wedge 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, MEH, JDI, KWY, KWZ, LPH, LWJ Dated: April 21, 2023 Received: April 24, 2023
Dear Valdimir Talley III:
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
1
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the text "Limin Sun-S" in a large, bold, sans-serif font. The text is black and is set against a white background. There is a faint, light blue watermark in the background that is partially obscured by the text. The watermark appears to be a stylized letter or symbol.
Limin Sun, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221323
Device Name Exactech® Alteon® Short Tapered Wedge
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 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.
- · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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® Short Tapered Wedge Femoral Stems
| Sponsor: | Exactech ® , Inc
2320 N.W. 66 th Court
Gainesville, FL 32653 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: (352) 327-4824 |
| | Fax: (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Contact Person: | Valdimir Talley III
Regulatory Affairs Specialist |
| Date: | August 26, 2022 |
| Proprietary Name: | Exactech ® Alteon ® Short Tapered Wedge |
| Common Name: | Femoral Stem Hip Prosthesis |
| Regulation Number and
Classification Names: | 21 CFR 888.3353 – Hip joint metal/ceramic/polymer semi-constrained
cemented or nonporous uncemented prosthesis.
21 CFR 888.3350 – Hip joint metal/polymer semi-constrained cemented
prosthesis.
21 CFR 888.3390 – Hip joint femoral (hemi-hip) metal/polymer cemented
or uncemented prosthesis.
21 CFR 888.3310 – Hip joint metal/polymer constrained cemented or
uncemented prosthesis.
21 CFR 888.3358 – Hip joint metal/polymer/metal semi-constrained
porous-coated uncemented prosthesis.
21 CFR 888.3360 – Hip joint femoral (hemi-hip) metallic cemented or
uncemented prosthesis. |
| Device Class: | Class II |
| Product Code: | LZO - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,
Cemented Or Non-Porous, Uncemented |
| Subsequent Product
Codes: | MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer,
Non-Porous, Calcium Phosphate
JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or
Uncemented |
4
Exactech® Alteon® Short Tapered Wedge Femoral Stems Traditional 510(k) - 510(k) Summary
KWZ - Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LWJ - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Classification Panel: Orthopedic
Legally Marketed Devices to Which Substantial Equivalence Is Claimed:
Table 1: Predicate Device System
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K140674 | Alteon Tapered Wedge Femoral Stems | Exactech, Inc |
Table 2: Reference Device
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K110400 | Taperloc Complete Microplasty Hip System | Biomet |
| Manufacturing | ||
| Corp. |
Device Description
The Exactech Alteon Short Tapered Wedge is a collarless, press-fit femoral stem component to be used in total or hemi hip arthroplasty, and is designed to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal.
The Alteon Short Tapered Wedge has seventeen size offerings and two lateral offsets per size. It is made from titanium alloy and includes a 12/14 trunnion, a polished neck region, a commercially pure titanium plasma spray coated press-fit region, and a bead-blasted (satin) distal surface finish. The 12/14 trumion allows for compatible connection with Exactech femoral heads. As a line extension to the predicate, the proposed Alteon Short Tapered Wedge differs from the predicate in that it features a shortened distal stem length.
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
5
Exactech® Alteon® Short Tapered Wedge Femoral Stems Traditional 510(k) - 510(k) Summary
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.
- Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Summary of Device Characteristics Comparison
The rationale for substantial equivalence is based on consideration of the following device use, design characteristics and performance requirements:
-
. Indications for Use
The subject and the predicate devices have the same indications for use. -
. Materials The subject and the predicate devices are composed of the same materials.
Performance Requirements .
The subject and the predicate devices conform to the same recognized performance standards for total hip replacement devices.
. Manufacturing and Sterilization
The proposed and predicate devices are made using similar manufacturing processes and are provided sterile via gamma radiation for single use only.
- Design Features ● The subject and the predicate devices have similar design features.
Non-Clinical Testing
The following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech Alteon Short Tapered Wedge perform as intended and are substantially equivalent to the identified predicate devices:
- Distally Fixed Fatigue testing (ISO 7206-4 and ASTM F2068) ●
- Femoral Neck Proximal Fatigue testing (ISO 7206-6 and ASTM F2068) ●
- Femoral Head Modular junction burst testing, fatigue testing, and pull-off (ISO 7206-10 and ASTM F2009)
- Coating characterization (ASTM F1854)
- Range of Motion analysis (ISO 21535)
- Template Studies ●
- Cadaveric Evaluation (BS EN 62366-1:2015+A1:2020) ●
6
Exactech® Alteon® Short Tapered Wedge Femoral Stems Traditional 510(k) - 510(k) Summary
Substantial Equivalence Conclusion
Based on consideration of indications for use, technological characteristics, and results of non-clinical testing, it was concluded that the Exactech Alteon Tapered Wedge femoral stems demonstrate substantial equivalence to the referenced predicate devices.