(52 days)
No
The summary describes a hip implant and its components, focusing on materials, design, and mechanical testing. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section.
Yes
The device is a component of a hip replacement system, indicated for use in conditions like osteoarthritis and rheumatoid arthritis, which are therapeutic interventions aimed at treating a disease or condition.
No
Explanation: This device is a hip implant (femoral stem for total or hemi hip arthroplasty), which is a treatment device, not a diagnostic one. Its purpose is to replace parts of the hip, not to diagnose a condition.
No
The device description clearly describes physical femoral stems and their materials, coatings, and intended use in surgical procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for hip replacement, addressing conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a femoral stem, a component of a hip prosthesis. This is a physical implant used within the body.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
The device is a surgical implant used in the treatment of musculoskeletal conditions.
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, KWY, LPH
Device Description
The Novation LPI Prime Femoral Stems are being re-branded as the Alteon Neck Preserving Femoral Stems.
The Alteon Neck Preserving Femoral Stems Sizes 6 and 7 are titanium press-fit prostheses featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The proximal region of the stem is coated with titanium plasma sprayfor uncemented, biological fixation.
The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:
- . Exactech Cobalt Chromium Alloy Femoral Heads (K041906)
- Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)
- Exactech BIOLOX® forte Alumina Femoral Heads (K023964, K051682) ●
- Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters . (K103012)
- AcuMatch L-series Unipolar endoprostheses (K010081) ●
The proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7are line extensions to the Novation LPI Prime Femoral Stems cleared in K121684. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7use the femoral neck geometry as the previously cleared Novation LPI Prime Femoral Stem Size 5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, proximal femoral
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 engineering analyses were conducted to demonstrate substantial equivalence of the proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7 to the predicate Novation LPI Prime Femoral Stem:
- . Template Study
- Beam theory calculations to determine worst case configurations ●
- Finite Element Analysis
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7 are substantially equivalent to cleared Novation LPI Prime Femoral Stem 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.
K041906, K050398, K060107, K023964, K051682, K103012, K010081
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
Exatech®, Incorporated Mr. Thomas McNamara Regulatory Affairs Associate 2320 Northwest 66th Court Gainesville, Florida 32653
Re: K141821
Trade/Device Name: Exactech® Alteon™ Neck Preserving Femoral Stems Sizes 6 and 7 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, LPH, KWY Dated: July 30, 2014 Received: August 1, 2014
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, 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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/Resourcesfor You/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 yours.
Ronald Dallean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exactech® Alteon™ Neck Preserving Femoral Stems Sizes 6 and 7 Special 510(k) - Indications For Use
Indications for Use
510(k) Number: __ K141821
Device Name: Exactech® Alteon™ Neck Preserving Femoral Stems Sizes 6 and 7
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.
Prescription Use X and/or (Part 21 CFR 801 Subpart D)
Over-The-
(21 CFR 80
Over-The-Counter Use (21 CFR 807 Subpart C)
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Exactech® Alteon™ Neck Preserving Femoral Stems Sizes 6 and 7 Special 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: | June 17, 2014 |
| Contact Person: | Thomas McNamara
Regulatory Affairs Associate
Telephone: (352) 377-1140
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Alteon™ Neck Preserving Femoral Stems Sizes 6
and 7 |
Common Name: Femoral Hip Stem
Classification Name:
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented (21 CFR Section 888.3353, Class II, Product Code LZO)
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (21 CFR Section 888.3390, Class II, Product Code KWY)
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358, Device Class: II, Product Code: LPH)
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
| Name | Manufacturer | 510(k) Number |
|---|---|---|
| Exactech Novation LPI Prime Femoral | ||
| Stem | Exactech, Inc | K121684 |
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.
4
Exactech® Alteon™ Neck Preserving Femoral Stems Sizes 6 and 7 Special 510(k) - 510(k) Summary
- 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.
Device Description
The Novation LPI Prime Femoral Stems are being re-branded as the Alteon Neck Preserving Femoral Stems.
The Alteon Neck Preserving Femoral Stems Sizes 6 and 7 are titanium press-fit prostheses featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The proximal region of the stem is coated with titanium plasma sprayfor uncemented, biological fixation.
The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:
- . Exactech Cobalt Chromium Alloy Femoral Heads (K041906)
- Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)
- Exactech BIOLOX® forte Alumina Femoral Heads (K023964, K051682) ●
- Exactech BioloxDelta and DeltaOption Femoral Heads and Adapters . (K103012)
- AcuMatch L-series Unipolar endoprostheses (K010081) ●
The proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7are line extensions to the Novation LPI Prime Femoral Stems cleared in K121684. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7use the femoral neck geometry as the previously cleared Novation LPI Prime Femoral Stem Size 5.
Testing:
The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7 to the predicate Novation LPI Prime Femoral Stem:
- . Template Study
- Beam theory calculations to determine worst case configurations ●
- Finite Element Analysis
Substantial Equivalence Conclusion:
Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Alteon Neck Preserving Femoral Stems Sizes 6 and 7 are substantially equivalent to cleared Novation LPI Prime Femoral Stem devices.