(15 days)
Not Found
No
The document describes a traditional hip implant system and focuses on material properties and mechanical performance, with no mention of AI or ML.
Yes
The device is a total hip replacement system, used to treat various medical conditions like osteoarthritis and fractures, thereby restoring function and alleviating symptoms.
No
This device is a total hip replacement system, indicated for various conditions requiring prosthetic replacement of the hip. It is a therapeutic device designed for surgical implantation, not for diagnosing medical conditions.
No
The device description and performance studies clearly indicate this is a physical hip implant system made of materials like titanium alloy and cobalt-chromium-molybdenum, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for total hip replacement. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a hip prosthesis made of specific materials and design, intended for implantation in the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting diseases or conditions, or providing information for diagnosis.
- Performance Studies: The performance studies focus on the mechanical properties and integrity of the implant materials, which are relevant to its function as a prosthesis, not a diagnostic tool.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is an in vivo (inside the body) implant.
N/A
Intended Use / Indications for Use
The Exactech HA - MCS Total Hip System is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rhematoid arthritis, ankvlosing spondylitis and /or posttraumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstruction's where sufficient bone stock is present.
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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. Exactech Hip Systems are also potentially indicated for revision of failed previous reconstruction's where sufficient bone stock is present.
Product codes (comma separated list FDA assigned to the subject device)
MEH
Device Description
The Exactech MCS - HA Porous Coated Total Hip System is made of similar materials and is of a similar design to prostheses that were on the market before May 28, 1976. Additionally, this Porous Coated Total Hip System is of similar design to other components on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976. The Exactech HA - MCS Total Hip System will be sterilized by gamma irradiation. The Sterility Assurance Level (SAL) is 104. Exactech utilizes Method 3, Protocol B from the "AAMI Guideline for gamma radiation sterilization" for the sterility dose setting and validation procedure.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature individuals
Intended User / Care Setting
Surgeon, for implantation during total hip arthroplasty surgery.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Material Integrity: Overall integrity has been previously determined in the initial 510(k) submissions K921113 and K921114. HA coating performance characteristics are further defined in the FDA Master File MAF339 (BioCoat, Inc.) Data obtained meets or exceeds predicate device data.
The evaluation of the interfacial shear strength of the uncoated sintered bead surface of the Exactech Porous System indicates excellent bonding of the beaded surface to the T1-6A1-4V substrate. Interfacial shear strengths in excess of 27 N/sq.mm can be expected with little variability based on the standard deviations observed for ten coating samples tested.
The integrity of the HA coating has been characterized. The HA coating tensile strength on porous coated Ti alloy has been shown to be approximately 55 MPa. The shear strength of the HA on Ti-6Al-4V and Co-Cr-Mo solid substrates has been shown to be between 5300 and 6500 psi. (36.6-44.8 MPa) while on porous coated Ti-6A1-4V and Co-Cr-Mo substrates the shear strength of the HA is between 5000 and 5900 psi. (34.5-40.7 MPa). Shear fatigue testing of the HA on Ti-6A1-4V shows a fatigue strength of 2000 psi. (13.8 MPa.) at 10 million cycles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Interfacial shear strength: > 27 N/sq.mm
HA coating tensile strength: approximately 55 MPa
HA shear strength on solid substrates: 5300-6500 psi (36.6-44.8 MPa)
HA shear strength on porous substrates: 5000-5900 psi (34.5-40.7 MPa)
Shear fatigue strength: 2000 psi (13.8 MPa) at 10 million cycles
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.
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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).
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§ 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.
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K990197
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION FOR THE PREMARKET NOTIFICATION FOR THE MODULUS COMPATIBLE STABILITY (MCS) - HA TOTAL HIP SYSTEM
Exactech, Inc. Established Registration Number 1038671
The Exactech MCS - HA Porous Coated Total Hip System is made of similar materials and is of a similar design to prostheses that were on the market before May 28, 1976. Additionally, this Porous Coated Total Hip System is of similar design to other components on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976. These predicates include but are not limited to:
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- Exactech MCS Total Hip System
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- Charnley
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- Zimmer Harris-Galante
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- Depuy AML
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- Osteonics Secur Fit HA
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- Smith & Nephew Synergy HA
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- OTI
Material Integrity:
Overall integrity has been previously determined in the initial 510(k) submissions K921113 and K921114. HA coating performance characteristics are further defined in the FDA Master File MAF339 (BioCoat, Inc.) Data obtained meets or exceeds predicate device data. A summary is presented below.
Summary:
The evaluation of the interfacial shear strength of the uncoated sintered bead surface of the Exactech Porous System indicates excellent bonding of the beaded surface to the T1-6A1-4V substrate. Interfacial shear strengths in excess of 27 N/sq.mm can be expected with little variability based on the standard deviations observed for ten coating samples tested.
The integrity of the HA coating has been characterized. The manufacturer acknowledges the importance of coating quality to the success of the device and has collaborated with BioCoat, Inc., a well know coating specialty company, for the application and characterization of its coatings. (Additional information regarding the HA coating has been provided to the FDA as MAF339 by BioCoat)
The HA coating tensile strength on porous coated Ti alloy has been shown to be approximately 55 MPa. The shear strength of the HA on Ti-6Al-4V and Co-Cr-Mo solid
1
substrates has been shown to be between 5300 and 6500 psi. (36.6-44.8 MPa) while on porous coated Ti-6A1-4V and Co-Cr-Mo substrates the shear strength of the HA is between 5000 and 5900 psi. (34.5-40.7 MPa). Shear fatigue testing of the HA on Ti-6A1-4V shows a fatigue strength of 2000 psi. (13.8 MPa.) at 10 million cycles.
Sterilization
The Exactech HA - MCS Total Hip System will be sterilized by gamma irradiation. The Sterility Assurance Level (SAL) is 104. Exactech utilizes Method 3, Protocol B from the "AAMI Guideline for gamma radiation sterilization" for the sterility dose setting and validation procedure.
Utilization and Implantation
Selection of the Exactech HA - MCS Hip System depends on the judgment of the surgeon in relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the technique of implantation by appropriate reading of the literature, and training in the operative skills and techniques required for total hip Arthoplasty surgery.
Indications
The Exactech HA - MCS Total Hip System is indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, osteonecrosis, congenital hip dysplasia, rhematoid arthritis, ankvlosing spondylitis and /or posttraumatic degenerative problems. It is also potentially indicated for revision of failed previous reconstruction's where sufficient bone stock is present.
Contraindications
Use of the Exactech HA - MCS Total Hip System is contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure to the system.
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Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized symbol consisting of three curved lines that resemble a person embracing another person.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 1999 FEB
Gary J. Miller, Ph.D. Vice President of Research and Development Exactech® 2320 NW 66th Court Gainesville, Florida 32653
Re : K990197 Ha Coated MCS Total Hip System Requlatory Class: II Product Code: MEH Dated: January 15, 1999 Received: January 20, 1999
Dear Dr. Miller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:
You may not label or in any way promote these devices for "enhanced clinical or radiographic performance, enhanced fixation and/or long-term stable fixation." The data presented support equivalence with no additional claims over a conventional porous coated hip prosthesis.
Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.
The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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Page 2 - Gary J. Miller, Ph.D.
You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.
Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes 895. compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be
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Page 3 - Gary J. Miller, Ph.D.
obtained from the Division of Small Manufacturers Assistance obcathed from the bivibror. or 638-2041 or (301) 443-6597 or at at Its Coll-free namber (600)- 050-2811-02-28 11:52 PM dsmamain.html".
Sincerely yours,
Neef R.P. Oyler
Celia M. Witten, Ph.D., M . Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
"INDICATIONS FOR USE"
510(k) Number (if known) _ K990197 7 ___
Device Name:
Indications for Use:
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, ankylosing spondylitis, congenital hip dysplasia, 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. Exactech Hip Systems are also potentially indicated for revision of failed previous reconstruction's where sufficient bone stock is present.
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over the Counter Use
MRO
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K990197