(70 days)
Not Found
No
The document describes a traditional hip implant device and its components. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies focus on mechanical testing of the implant.
Yes
The device is a hip replacement system intended for surgical implantation to treat various hip conditions, including osteoarthritis, rheumatoid arthritis, and fractures, which are therapeutic interventions.
No
The device is a hip implant used for replacement surgery, not for diagnosing medical conditions.
No
The device description clearly describes a physical, modular two-piece implant made of cobalt chrome and polyethylene, which are hardware components.
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 surgical implant for hip replacement, addressing various conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of metal and polyethylene, designed to be surgically placed within the body. IVD devices are typically used to examine samples (like blood, urine, or tissue) outside the body to diagnose or monitor conditions.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
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.
Product codes
KWY
Device Description
The AcuMatch L-Series Bipolar is a modular two piece device consisting of a spherical cobalt chrome shell (ASTM 1537 or ASTM F75) and interchangeable polyethylene liner inserts (ASTM F638). The metal head components come in 24 sizes (38mm through 61mm). The liner options include 22, 26, 28 and 32 mm inside diameter (1.D.) offerings. The implants are supplied sterile to an assurance level (SAL) of 10°.
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
Surgeon, 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)
Functional testing and engineering analysis were conducted to verify that the implant performance would be adequate for anticipated in vivo load applications. This performance data includes cam-out testing, assembly testing, and a range of motion evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
Exactech® AcuMatch™ Integrated Hip System L-Series Bipolar Endoprosthesis
DEC 0 5 2001
2 Series Biros Bigotal Enaoprossioness K Ol 32-1 (
510(k) Summary of Safety and Effectiveness K Ol 32-1 (
Special 510(k)
Classifications / Proprietary Names:
| Classification Name: | Prosthesis, Hip, Hemi-, Femoral,
Metal/Polymer, Cemented or Uncemented |
|----------------------------------|---------------------------------------------------------------------------|
| Product Code: | KWY |
| C.F.R. Section: | 888.3390 |
| Device Class: | II |
| Classification Panel: | Orthopedic |
| Trade / Proprietary Model Names: | AcuMatch L-Series Bipolar Endoprosthesis |
Legally Marketed Devices for Substantial Equivalence Comparison:
| Model | Manufacturer | 510(k) Number |
|---|---|---|
| Exactech Bipolar | Exactech, Inc. | #K905370 |
| Giliberty | Zimmer | |
| Bi-articular | Zimmer | |
| Centrax | Howmedica | |
| Conversion | Richards | |
| Self-Centering | Depuy |
Device Description:
INDICATIONS
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.
Section 4 Page 2 of 3
1
Exactech® AcuMatch™ Integrated Hip System L-Series Bipolar Endoprosthesis
510(k) Summary of Safety and Effectiveness Special 510(k)
CONTRAINDICATIONS
Exactech Hip Systems are 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 of the system. The L-Series unipolar and bipolar endoprostheses are also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.
DESIGN
The AcuMatch L-Series Bipolar is a modular two piece device consisting of a spherical cobalt chrome shell (ASTM 1537 or ASTM F75) and interchangeable polyethylene liner inserts (ASTM F638). The metal head components come in 24 sizes (38mm through 61mm). The liner options include 22, 26, 28 and 32 mm inside diameter (1.D.) offerings. The implants are supplied sterile to an assurance level (SAL) of 10°.
PERFORMANCE DATA
Functional testing and engineering analysis were conducted to verify that the implant performance would be adequate for anticipated in vivo load applications. This performance data includes cam-out testing, assembly testing, and a range of motion evaluation.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 5 2001
Ms. Lisa Simpson Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653
Re: K013211
Trade Name: AcuMatch L-Series Bipolar Endoprosthesis Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY Dated: October 26, 2001 Received: November 6, 2001
Dear Ms. Simpson:
We have reviewed your Section 510(k) premarket 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) 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Lisa Simpson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
to Mark A. Mullane
Celia M. Witten. Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exactech®, Inc.
Indications for Use
KO13211_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number:
Device Name:
AcuMatch L-Series Bipolar Endoprosthesis
INDICATIONS
INDICATIONS
All Exactech Hip Systems are indicated for use in skeletally mature individuals r in Exaction inpost 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 the bargeon addicated 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.
CONTRAINDICATIONS
Exactech Hip Systems are 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 of the witters The L-Series unipolar and bipolar endoprostheses are also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X Over the Counter Use __
Mark N Millkum
(Division Sign-Off)
Div. General, Restorative
and Neurological Devices
Section 3
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