(112 days)
No
The summary describes a passive medical device (acetabular liners) and the testing performed to demonstrate its performance and equivalence to predicate devices. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device, an acetabular liner, is intended for use in total hip replacement, which is a surgical procedure to treat conditions like osteoarthritis and rheumatoid arthritis, aiming to restore mobility and alleviate pain. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device described is an acetabular liner, which is a component of a hip replacement system. Its purpose is to physically replace a part of the hip joint in surgery, rather than to diagnose a condition.
No
The device description clearly states that the device is a physical implant (Acetabular Liners) made from Ultra-High Molecular Weight Polyethylene. The performance studies also focus on material characteristics, mechanical testing, and wear analysis, which are relevant to physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical hip replacement. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an acetabular liner, a component of a hip implant. This is a physical implant used in surgery, not a reagent, instrument, or system used to test biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any of the typical characteristics of an IVD.
The device is a medical device, specifically a prosthetic implant, but it does not fit the definition of 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, theumatoid arthritis, osteonerative 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)
OOI, LZO, MEH
Device Description
Exactech Novation and AcuMatch E-HXL Acetabular Liners are intended for use in total hip replacement as an interface between acetabular shells and femoral heads. Both Novation E-HXL Acetabular Liners and AcuMatch E-HXL Acetabular Liners are manufactured from Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol). The Novation E-HXL Acetabular Liners are available in five configurations (neutral, lipped, anterior lipped, +5mm lateralized, and 10 deg. face changing) with inner diameter ranging between 22mm and 40mm. The AcuMatch E-HXL Acetabular Liners are available in four configurations (0 deg., ext coverage, and +5mm lateralized) with inner diameter ranging between 28mm and 36mm. The overall design goals of the proposed Exactech Novation and AcuMatch E-HXL Acetabular Liners are to improve wear performance and provide oxidative stability in comparison to the predicate Exactech Novation and AcuMatch GXL Acetabular Liners.
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 material characterization, biocompatibility testing/analysis, wear analyses, mechanical testing, and engineering evaluation were performed to demonstrate that the Exactech Novation and AcuMatch E-HXL Acetabular Liners perform as intended and are substantially equivalent to the identified predicate devices:
- Material Characterization
- Biocompatibility Testing and Analysis
- Extractive Testing
- Standard and Aggressive Wear Analyses
- Impingement 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 to ensure the proposed Novation and AcuMatch E-HXL Acetabular Liners 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.
K051556, K070479, K100269, K121392, K111481
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 logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 12, 2018
Exactech, Inc. Shing Jen Tai Senior Regulatory Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K173583
Trade/Device Name: Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners 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: OOI, LZO, MEH Dated: February 7, 2018 Received: February 8, 2018
Dear Shing Jen Tai:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Katherine D. Kavlock -S
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)
K173583
Device Name
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
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, theumatoid arthritis, osteonerative 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 201 Subpart D) |
| Over-The-Counter Use (21 CFR 201 Subpart C) |
XJ Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners Traditional 510(k) - 510(k) Summary
| Company: | Exactech®, Inc
2320 NW 66th Court
Gainesville, FL 32653 |
|----------------------|----------------------------------------------------------------------------------------------------------------------|
| Date: | March 12, 2018 |
| Contact Person: | Shing Jen Tai, PhD
Sr. Regulatory Affairs Specialist |
| | Phone: (352) 327-4638
Fax: (352) 378-2617 |
| Proprietary Name: | Exactech® Novation® and AcuMatch® E-HXL Acetabular
Liners |
| 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: | OOI, LZO, MEH |
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
- Exatech® AcuMatch® A-Series Connexion GXL Enhanced UHMWPE Acetabular o Liner (K051556)
- Exactech Novation® Crown Cup® and Liners (K070479) ●
- Exactech Novation®Crown Cup® and Liners (K100269) 0
- Exactech Novation® Crown Cup® GXL UHMWPE Liner (K121392) ●
- Corin Trinity Acetabular System ECIMA Liners (K111481) ●
Reference Devices
- Biomet E1 Polyethylene Liners (K050327) ●
Device Description
Exactech Novation and AcuMatch E-HXL Acetabular Liners are intended for use in total hip replacement as an interface between acetabular shells and femoral heads. Both Novation E-HXL Acetabular Liners and AcuMatch E-HXL Acetabular Liners are manufactured from Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol). The Novation E-HXL Acetabular Liners are available in five
4
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners Traditional 510(k) - 510(k) Summary
configurations (neutral, lipped, anterior lipped, +5mm lateralized, and 10 deg. face changing) with inner diameter ranging between 22mm and 40mm. The AcuMatch E-HXL Acetabular Liners are available in four configurations (0 deg., ext coverage, and +5mm lateralized) with inner diameter ranging between 28mm and 36mm. The overall design goals of the proposed Exactech Novation and AcuMatch E-HXL Acetabular Liners are to improve wear performance and provide oxidative stability in comparison to the predicate Exactech Novation and AcuMatch GXL Acetabular Liners.
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.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following device use and characteristics:
- 0 Indications for Use. The proposed Exactech Novation and AcuMatch E-HXL Acetabular Liners and the predicate devices have the same or similar indications for use.
- Materials. The proposed Exactech Novation and AcuMatch E-HXL Acetabular . Liners and the predicate devices are composed of the same or similar biocompatible materials.
- . Design Features. The proposed Exactech Novation and AcuMatch E-HXL Acetabular Liners and the predicate devices have the same or similar design features.
- Dimensions. The proposed Exactech Novation and AcuMatch E-HXL Acetabular Liners and the predicate devices are dimensionally equivalent or comparable.
- Sterilization. The proposed Exactech Novation and AcuMatch E-HXL . Acetabular Liners and the predicate devices are provided sterile for single use only.
5
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners Traditional 510(k) - 510(k) Summary
- Performance Requirements. The proposed Exactech Novation and AcuMatch o E-HXL Acetabular Liners and the predicate devices conform to recognized performance standards for total hip replacement devices.
Non-Clinical Testing
The following material characterization, biocompatibility testing/analysis, wear analyses, mechanical testing, and engineering evaluation were performed to demonstrate that the Exactech Novation and AcuMatch E-HXL Acetabular Liners perform as intended and are substantially equivalent to the identified predicate devices:
- Material Characterization ●
- Biocompatibility Testing and Analysis ●
- Extractive Testing ●
- Standard and Aggressive Wear Analyses ●
- Impingement Testing ●
- Axial Push-Out Testing
- Torque Out Testing ●
- Offset Pull-Out Testing
- o Range of Motion Analysis
Pyrogen testing was conducted in accordance with USP , USP , and ANSI/AAMI ST72 to ensure the proposed Novation and AcuMatch E-HXL Acetabular Liners 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, biocompatibility of the proposed devices, and results of material characterization, wear analyses, mechanical testing, and engineering evaluation, it was concluded that the Exactech Novation and AcuMatch E-HXL Acetabular Liners demonstrate substantial equivalence to the referenced predicate devices.