(200 days)
No
The summary describes a mechanical implant system for hip replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a component of a hip replacement system, which is a medical intervention designed to treat and improve the function of a diseased or damaged hip joint.
No
The device is an orthopedic implant for hip replacement surgery, designed to restore joint function rather than diagnose a medical condition.
No
The device description clearly states it is a system of modular implants made from CoCr alloy and Ultra-High Molecular Weight Polyethylene, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a component of a hip replacement system used in surgery for various hip conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the materials and configurations of the implants (liners and inserts) used in total hip arthroplasty. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
In summary, the Exactech Alteon Modular Dual Mobility (MDM) System is a surgical implant used in hip replacement procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Exactech Alteon Modular Dual Mobility (MDM) System is a component of the Alteon Acetabular System. The Alteon MDM System is indicated for skeletally mature individuals undergoing surgery for hip replacement due to osteoarthritis, theumatoid arthritis, osteonecrosis or post-traumatic degenerative problems of the hip. The Alteon Modular Dual Mobility System is also potentially indicated for ankylosing spondylitis, congenital hip dysplasia and to restore mobility resulting from previous fusion. The Alteon MDM System is also indicated for use in primary or revision patients at a high risk of hip dislocation.
The Alteon Acetabular System is intended for press-fit fixation.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The Alteon® MDM System provides modular implants for use in total hip arthroplasty (THA) to restore patient joint function. The Exactech® Alteon® Modular Dual Mobility (MDM) System is intended for use in total hip replacement as an interface between the acetabulum and femoral heads. The Alteon® MDM liners and inserts are manufactured from CoCr alloy and Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol), respectively. The Alteon® MDM liners and inserts are each available in seven configurations. The Alteon® MDM insert inner diameter (femoral head compatibility) includes 22mm or 28mm, while the Alteon® MDM liners are compatible with acetabular shells with outer diameters 46-68mm.
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:
- Biocompatibility Analysis
- Wear Testing
- Fretting/Corrosion Testing
- Impingement Testing
- Lever-Out Testing
- Axial Push-Out Testing
- Torque Out Testing
- Offset Pull-Out Testing
- Range of Motion Analysis
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72.
Key Results: demonstrates substantial equivalence to 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.
K173583, K182502, K103233, K150522, K101336
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
October 22, 2019
Image /page/0/Picture/1 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, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Exactech, Inc. Liz Howell Regulatory Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K190890
Trade/Device Name: Exactech Alteon Modular Dual Mobility (MDM) System 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 Dated: September 17, 2019 Received: September 19, 2019
Dear Liz Howell:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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.
FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190890
Device Name
Exactech® Alteon® Modular Dual Mobility (MDM) System
Indications for Use (Describe)
The Exactech Alteon Modular Dual Mobility (MDM) System is a component of the Alteon Acetabular System. The Alteon MDM System is indicated for skeletally mature individuals undergoing surgery for hip replacement due to osteoarthritis, theumatoid arthritis, osteonecrosis or post-traumatic degenerative problems of the hip. The Alteon Modular Dual Mobility System is also potentially indicated for ankylosing spondylitis, congenital hip dysplasia and to restore mobility resulting from previous fusion. The Alteon MDM System is also indicated for use in primary or revision patients at a high risk of hip dislocation.
The Alteon Acetabular System is intended for press-fit fixation.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Exactech® Alteon® Modular Dual Mobility (MDM) System Traditional 510(k) - 510(k) Summarv
| Company: | Exactech®, Inc
2320 NW 66th Court
Gainesville, FL 32653 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 17, 2019 |
| Contact Person: | Liz Howell
Regulatory Affairs Specialist |
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Alteon® Modular Dual Mobility (MDM) System |
| Common Name: | Total Hip Prosthesis Acetabular Component |
| Classification Name: | 21 CFR 888.3353, Hip Joint Metal/Ceramic/Polymer
Semi-Constrained Cemented or Nonporous Uncemented Prosthesis
Class II |
| Product Code: | LZO |
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
- Corin Trinity™ Dual Mobility System (K170359) ●
Reference Devices
- Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (K173583) ●
- Exactech® Alteon® Acetabular Cups and Acetabular Liners (K182502) ●
- Stryker Modular Dual Mobility (MDMTM) Liner and X3® Acetabular Insert (K103233) ●
- Biomet G7 Dual Mobility System (K150522), E1TM Avantage™ Head (a.k.a. E1TM ● Active Articulation) (K101336)
Device Description
The Alteon® MDM System provides modular implants for use in total hip arthroplasty (THA) to restore patient joint function. The Exactech® Alteon® Modular Dual Mobility (MDM) System is intended for use in total hip replacement as an interface between the acetabulum and femoral heads. The Alteon® MDM liners and inserts are manufactured from CoCr alloy and Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol), respectively. The Alteon® MDM liners and inserts are each available in seven configurations. The Alteon® MDM insert inner diameter (femoral head compatibility) includes 22mm or 28mm, while the Alteon® MDM liners are compatible with acetabular shells with outer diameters 46-68mm.
4
Exactech® Alteon® Modular Dual Mobility (MDM) System Traditional 510(k) - 510(k) Summary
Indications for Use
The Exactech® Alteon® Modular Dual Mobility (MDM) System is a component of the Alteon® Acetabular System. The Alteon® MDM System is indicated for skeletally mature individuals undergoing surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis or post-traumatic degenerative problems of the hip. The Alteon® Modular Dual Mobility System is also potentially indicated for ankylosing spondylitis, congenital hip dysplasia and to restore mobility resulting from previous fusion. The Alteon® MDM System is also indicated for use in primary or revision patients at a high risk of hip dislocation.
The Alteon® Acetabular System is intended for press-fit fixation.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following device use and characteristics:
- Indications for Use. The proposed Exactech® Alteon® Modular Dual Mobility System components and the predicate devices have the same or similar indications for use.
- Materials. The proposed Exactech® Alteon® Modular Dual Mobility System components and the predicate devices are composed of the same or similar biocompatible materials.
- Design Features. The proposed Exactech® Alteon® Modular Dual Mobility System components and the predicate devices have the same or similar design features.
- . Dimensions. The proposed Exactech® Alteon® Modular Dual Mobility System components and the predicate devices are dimensionally equivalent or comparable.
- Sterilization. The proposed Exactech® Alteon® Modular Dual Mobility System ● components and the predicate devices are provided sterile for single use only.
- Performance Requirements. The proposed Exactech® Alteon® Modular Dual Mobility ● System components and the predicate devices conform to recognized performance standards for total hip replacement devices.
Non-Clinical Testing
The following biocompatibility testing/analysis, wear analyses, mechanical testing, and engineering evaluations were performed to demonstrate that the Alteon® MDM System performs as intended and is substantially equivalent to the identified predicate devices:
- Biocompatibility Analysis ●
- Wear Testing ●
- Fretting/Corrosion Testing
- Impingement Testing
- Lever-Out Testing
- Axial Push-Out Testing ●
- Torque Out Testing ●
- Offset Pull-Out Testing ●
- Range of Motion Analysis ●
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Exactech® Alteon® Modular Dual Mobility (MDM) System Traditional 510(k) - 510(k) Summary
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Alteon® MDM System meets 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, biocompatibility of the proposed devices, and results of wear analyses, mechanical testing, and engineering evaluations, the Exactech® Alteon® Modular Dual Mobility System demonstrates substantial equivalence to referenced predicate devices.
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