(104 days)
Not Found
No
The 510(k) summary describes a traditional hip implant device and its associated instrumentation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies are standard mechanical and biocompatibility tests for implants.
Yes
The device is a component of a hip replacement system, indicated for conditions like osteoarthritis and rheumatoid arthritis, which are used to treat and alleviate these medical conditions.
No
This device is a hip implant (femoral stem) used for hip replacement surgery due to various conditions like osteoarthritis or fractures. It is a prosthetic device for treatment, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant (femoral stem) made of titanium alloy, available in various sizes and configurations, intended for surgical implantation. It also mentions accompanying instrumentation. This is a hardware medical device, not software-only.
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 for surgical implantation in the human body to replace a hip joint. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The description details a physical implant (femoral stem) and associated components for surgical use. It does not mention any reagents, calibrators, or other materials used to test samples from the human body.
- Lack of Diagnostic Function: The device's function is to provide structural support and restore mobility to the hip joint. It does not analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the mechanical properties, fatigue strength, and biocompatibility of the implant, which are relevant to a surgically implanted device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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, KWY
Device Description
Exactech Tapered Wedge Femoral Stem is a collarless, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The overall design goal of the Exactech Tapered Wedge Femoral Stem is to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal.
Manufactured from titanium alloy, the subject stem is available in 17 sizes with two lateral offsets offered for each size and two surface finish options (commercially pure titanium, and hydroxylapatite over commercially pure titanium) for the press-fit region of the device. Together, there are 68 total femoral stem configurations available to accommodate patients' various anatomical needs. Regardless of configuration, all Tapered Wedge Femoral Stems feature a polished neck region and bead blast (satin) surface finish on the distal region of the femoral stem. Exactech Tapered Wedge Femoral Stems are intended for press-fit applications. With respect to devicecompatibility with other Exactech manufactured products, Tapered Wedge Femoral Stem is designed to be used with the following 12/14 femoral heads and AcuMatch bipolar components.
The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:
- Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392) .
- Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)
- Exactech BIOLOX® forte Alumina Femoral Heads (K032964, K051682)
- Exactech BioloxDelta and BioloxOption Femoral Heads and Adapters (K103012, K121392)
- Exactech AcuMatch L-series Unipolar endoprosthesis (K010081)
The proposed femoral stems are intended to mate with the following bipolar components: - Exactech AcuMatch L-Series Bipolar Endoprosthesis (K013211)
The Exactech Tapered Wedge Femoral Stem is accompanied by a complete instrumentation set including trial and broach/rasp system to assist surgeons in implantation of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, 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 clinical literature review, template studies, mechanical testing, and cadaveric evaluation were performed to demonstrate that the Exactech Tapered Wedge Femoral Stem performs as intended and is substantially equivalent to the identified predicate devices:
- Clinical Literature Review of similar femoral prostheses.
- Template Studies.
- Range of Motion Testing per ISO 21535.
- Distally Fixed Fatigue Testing of worst case per FDA guidance.
- Femoral Neck Fatigue Testing of worst case per FDA guidance.
- Femoral Head Modular Junction Burst Testing, Fatigue Testing, and Axial pull-off Testing on Exactech taper specification per ISO 7206-10 and ASTM F2009-00.
- Cadaveric evaluation.
- Microstructural characterization and mechanical testing completed for the dual coating of the Exactech Tapered Wedge Femoral Stem.
- Biocompatibility testing performed on the colorants used in production of instruments.
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.
K120578, K101086, K103755, K042842
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
JUN 3 0 2014
510(k) Summary
Sr. Regulatory Affairs Specialist
Exactech® Tapered Wedge Femoral Stem
Shing Jen Tai, PhD
Femoral Hip Stem
Phone: (352) 327-4638 Fax: (352) 378-2617
| Company: | Exactech®, Inc |
|---|---|
| 2320 NW 66th Court | |
| Gainesville, FL 32653 |
June 30, 2014
Contact Person:
Date:
Proprietary Name:
Common Name:
Classification Names for Proposed Device:
Classification Names for Compatible Devices:
21 CFR 888.3353, Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis; 21 CFR 888.3390, Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis;
21 CFR 888.3350, Hip joint metal/polymer semiconstrained cemented prosthesis 21 CFR 888.3358, Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis 21 CFR 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis 21 CFR 888.3310, Hip joint metal/polymer constrained cemented or uncemented prosthesis
Class II
Product Codes for Proposed Device:
LZO, MEH, KWY
Product Codes for Compatible Devices:
JDI, LPH, LWJ, KWZ
1
Legally Marketed Device to Which Substantial Equivalence Is Claimed:
- Accolade II Hip Stem (K 120578) from Howmedica Osteonics Corp. (a subsidiary ● of Stryker Corporation)
- Taperloc Complete (K101086, and K103755 line extension to devices cleared in . · K101086) from Biomet Inc.
- Novation 12/14 Press-Fit Femoral Stems (K042842) from Exactech Inc. .
Device Description
Exactech Tapered Wedge Femoral Stem is a collarless, press-fit prosthesis featuring a 12/14 trunnion that is used on the femur side of a total or hemi hip arthroplasty. The overall design goal of the Exactech Tapered Wedge Femoral Stem is to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal.
Manufactured from titanium alloy, the subject stem is available in 17 sizes with two lateral offsets offered for each size and two surface finish options (commercially pure titanium, and hydroxylapatite over commercially pure titanium) for the press-fit region of the device. Together, there are 68 total femoral stem configurations available to accommodate patients' various anatomical needs. Regardless of configuration, all Tapered Wedge Femoral Stems feature a polished neck region and bead blast (satin) surface finish on the distal region of the femoral stem. Exactech Tapered Wedge Femoral Stems are intended for press-fit applications. With respect to devicecompatibility with other Exactech manufactured products, Tapered Wedge Femoral Stem is designed to be used with the following 12/14 femoral heads and AcuMatch bipolar components.
The proposed femoral stems are intended to mate with the following modular 12/14 femoral heads:
- Exactech Cobalt Chromium Alloy Femoral Heads (K041906, K121392) .
- . Exactech Ziramic Zirconia Femoral Heads (K050398, K060107)
- Exactech BIOLOX® forte Alumina Femoral Heads (K032964, K051682) .
- Exactech BioloxDelta and BioloxOption Femoral Heads and Adapters (K103012, . K121392)
- . Exactech AcuMatch L-series Unipolar endoprosthesis (K010081)
The proposed femoral stems are intended to mate with the following bipolar components:
- . Exactech AcuMatch L-Series Bipolar Endoprosthesis (K013211)
The Exactech Tapered Wedge Femoral Stem is accompanied by a complete instrumentation set including trial and broach/rasp system to assist surgeons in implantation of the device.
2
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:
- . Indications for Use. The proposed Exactech Tapered Wedge Femoral Stem and the predicate devices have same or similar indications for use.
- Materials/Surface Finish/Coatings. The proposed Exactech Tapered Wedge . Femoral Stem and the predicate devices are composed of similar, biocompatible substrate materials, and the same or similar surface finish/coatings for permanent implants.
- Design Features. The proposed Exactech Tapered Wedge Femoral Stem and the . predicate devices share similar design features.
- Dimensions. The proposed Exactech Tapered Wedge Femoral Stem and the . predicate devices are dimensionally comparable.
- Sterilization. The proposed Exactech Tapered Wedge Femoral Stem and the . predicate devices are provided sterile for single use only.
- Performance Requirements. The proposed Exactech Tapered Wedge Femoral . Stem and the predicate devices conform to recognized performance standards for total hip replacement devices.
Non-Clinical Testing
The following clinical literature review, template studies, mechanical testing, and cadaveric evaluation were performed to demonstrate that the Exactech Tapered Wedge Femoral Stem performs as intended and is substantially equivalent to the identified predicate devices:
- Clinical Literature Review of similar femoral prostheses. .
- . Template Studies.
- Range of Motion Testing per ISO 21535. .
3
- Distally Fixed Fatigue Testing of worst case per FDA guidance. .
- Femoral Neck Fatigue Testing of worst case per FDA guidance. .
- Femoral Head Modular Junction Burst Testing, Fatigue Testing, and Axial pull-. off Testing on Exactech taper specification per ISO 7206-10 and ASTM F2009-00.
- . Cadaveric evaluation.
- . Microstructural characterization and mechanical testing completed for the dual coating of the Exactech Tapered Wedge Femoral Stem.
- Biocompatibility testing performed on the colorants used in production of . instruments.
Substantial Equivalence Conclusion
Based on consideration of indications for use, technological characteristics, and results of combined mechanical testing, cadaveric validation study, template studies, and clinical literature review described above, it was concluded that Exactech Tapered Wedge Femoral Stem demonstrates substantial equivalence to the referenced predicate devices.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2014
Exactech Inc. Dr. Shing Jen Tai Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K140674
Trade/Device Name: Exactech® Tapered Wedge Femoral 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, MEH, KWY, LPH, JDI, LWJ, KWZ Dated: May 23, 2014 Received: May 27, 2014
Dear Dr. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Dr. Shing Jen Tai
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/ResourcesforYou/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,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
K140674 510(k) Number:
Device Name: Exactech® Tapered Wedge Femoral Stem
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, 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-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)
Elizabeth L. Frank -S
Division of Orthopedic Devices