(85 days)
Not Found
No
The summary describes a mechanical implant (femoral stem) and its intended use in hip replacement surgery. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device, a hip implant, is used to treat medical conditions like osteoarthritis and osteonecrosis, aiming to restore mobility and function, which are characteristic goals of therapeutic devices.
No
Explanation: This device is a revision femoral stem, which is a prosthetic implant used in hip replacement surgery. Its purpose is to treat conditions like osteoarthritis and hip fractures by replacing damaged bone, not to diagnose them.
No
The device description clearly describes a physical implant (femoral stem) and its intended use in surgical procedures, indicating it is a hardware medical device. There is no mention of software as the primary or sole component.
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 detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Alteon Monobloc Revision Femoral Stem is a "distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty." This describes an implantable surgical device, not a device used for testing biological samples.
- Intended Use: The intended use is for "primary surgery for hip replacement" and "revision of failed previous reconstructions," which are surgical procedures, not diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Alteon Monobloc Revision Femoral Stem is a surgical implant, not an In Vitro Diagnostic device.
No
The provided information does not mention a Predetermined Change Control Plan (PCCP) and describes a traditional 510(k) clearance for a line extension of an existing device.
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.
- 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
LZO
Device Description
The Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The Alteon Monobloc Revision Stem system is intended to treat typical Total Hip Arthroplasty primary and revision cases. Compared to predicate Alteon Monobloc Revision Stems implants, proposed Alteon Monobloc Revision Stem line extension implants offer a longer stem length option, a reduced neck offset option, and options for intermediately sized stem diameters to accommodate an array of patient anatomies.
Both the proposed and predicate devices are identical per:
- The Indications for Use
- The intended use
- Design features and geometry
- Materials and surface finishes
- Implantation methods
- Compatibility
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)
The following non-clinical testing has been performed to demonstrate that the Exactech Alteon Monobloc Revision Stem line extensions perform as intended and are substantially equivalent to the identified predicate devices:
- Fatigue testing
- Range of motion analysis
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Alteon Monobloc Revision Stem line extension components 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
September 4, 2018
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
Exactech®, Inc. Zach Sharrah Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K181532
Trade/Device Name: Exactech® Alteon® Monobloc Revision 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 Dated: August 13, 2018 Received: August 14, 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 2018.09.04 13:55:13 -04'00'
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) K181532
Device Name
Exactech® Alteon® Monobloc Revision 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.
- · 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) |
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Exactech® Alteon® Monobloc Revision Stem Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness
| Sponsor: | Exactech®, Inc.
2320 N.W. 66th Court
Gainesville, FL 32653 |
|-------------------|---------------------------------------------------------------------------------------------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| | FDA Establishment Number 1038671 |
| Contact: | Zach Sharrah
Regulatory Affairs Specialist
Telephone: (352) 377-1140
Fax: (352) 378-2617 |
| Date: | 6 June 2018 |
| Proprietary Name: | Exactech® Alteon® Monobloc Revision Stem |
| Common Name: | Total Hip Arthroplasty – Femoral Components |
Classification Name:
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (CFR 888.3353, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis, Class II, Product Code LZO)
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Exactech Alteon Monobloc Revision Stem | Exactech, Inc. | K150066 |
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.
4
Exactech® Alteon® Monobloc Revision Stem Line Extensions Special 510(k) - 510(k) Summary of Safety and Effectiveness
Device Description:
The Alteon Monobloc Revision Femoral Stem is a distally tapered, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The Alteon Monobloc Revision Stem system is intended to treat typical Total Hip Arthroplasty primary and revision cases. Compared to predicate Alteon Monobloc Revision Stems implants, proposed Alteon Monobloc Revision Stem line extension implants offer a longer stem length option, a reduced neck offset option, and options for intermediately sized stem diameters to accommodate an array of patient anatomies.
Both the proposed and predicate devices are identical per:
- · The Indications for Use
- · The intended use
- · Design features and geometry
- · Materials and surface finishes
- · Implantation methods
- · Compatibility
Non-Clinical Testing:
The following non-clinical testing has been performed to demonstrate that the Exactech Alteon Monobloc Revision Stem line extensions perform as intended and are substantially equivalent to the identified predicate devices:
- Fatigue testing
- Range of motion analysis ●
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Alteon Monobloc Revision Stem line extension components 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:
Detailed feature comparison and results of testing referenced in this submission demonstrate the proposed Exactech Alteon Monobloc Revision Stem line extensions are substantially equivalent to the cited cleared predicate Exactech Alteon Monobloc Revision Stem devices.