(26 days)
The AcuMatch L-Series Unipolar Endoprosthesis is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture.
The AcuMatch L-Series Unipolar is a modular endoprosthesis consisting of a truncated spherical head and interchangeable neck sleeves. The device is fully machined from cobalt chrome alloy conforming to ASTM F1537-94. The size offerings include 15 head sizes (38 mm - 62 mm) with four available offset options (-5, +0, +5 and +10).
The Exactech® AcuMatch™ Integrated Hip System L-Series Unipolar Endoprosthesis is a modular endoprosthesis consisting of a truncated spherical head and interchangeable neck sleeves for hip hemiarthroplasty.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical integrity under anticipated in-vivo loading | Functional testing and engineering analysis (FEA, fatigue testing, material certifications) demonstrated adequate performance for anticipated in vivo loading. |
| Substantial equivalence to predicate device (Exactech Opteon Unipolar device #K960538) in terms of materials and design. | The device is made of similar materials (cobalt chrome) and has similar design features (spherical design, offset sizing options) to the predicate. Functional testing and engineering analysis confirmed substantial equivalence. |
| Material composition adheres to ASTM F1537-94. | The device is fully machined from material conforming to ASTM F1537-94. |
| Sterilization Assurance Level (SAL) of 10-6 achieved. | Sterilization by Gamma radiation (25-37 kGy Cobalt 60 source) achieves an SAL of 10-6. |
2. Sample size used for the test set and the data provenance:
This document describes a submission for a medical device (hip endoprosthesis) and does not involve AI software or a "test set" in the context of clinical data for AI model validation. The "testing" referred to is mechanical and engineering testing, not clinical data analysis. The data provenance is from the manufacturer's internal engineering and material testing processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the submission pertains to a physical medical device and its mechanical and material properties, not an AI model requiring human experts for ground truth establishment.
4. Adjudication method for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable.
7. The type of ground truth used:
The "ground truth" in this context refers to established engineering standards, material specifications (ASTM F1537-94), and the performance characteristics of the predicate device (Exactech Opteon Unipolar device #K960538). These are based on published standards and previous regulatory approvals of the predicate device.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
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2320 NW 66TH COUR GAINESVILLE, FL 3265
352-377-1140
FAX 352-378-2617
Exactech® AcuMatch™ Integrated Hip System L-Series Unipolar Endoprosthesis
01008
FEB - 5 2001
Sponsor:
510(k) Summary of Safety and Effectiveness Special 510(k)
Exactech® Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
(352) - 377 - 1140 Phone: (352) - 378 - 2617 Fax:
FDA Establishment Number 1038671
Gary J. Miller, Ph.D. Contact: Executive V.P. of Research and Development
Date:
01)08 DI
Section 4 Page 1 of 4
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510(k) Summary of Safety and Effectiveness Special 510(k)
Classifications / Proprietary Names:
| Classification Name: | Prosthesis, Hip, Hemi-, Femoral, Metal |
|---|---|
| Product Code: | KWL |
| C.F.R. Section: | 888.3360 |
| Device Class: | II |
| Classification Panel: | Orthopedic |
| 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 Unipolar Endoprosthesis
Legally Marketed Devices for Substantial Equivalence Comparison:
The Exactech AcuMatch L-Series Endoprosthesis is made of similar materials and is of a similar design to other legally marketed femoral components, most notably the Exactech Opteon Endoprosthesis:
| Model | Manufacturer | 510(k) Number |
|---|---|---|
| Opteon Unipolar Endoprosthesis | Exactech, Inc. | K960538 |
| Unitrax Unipolar System | Howmedica | ---------- |
| Unipolar System | Smith & Nephew | ---------- |
| Bio-Moore II | BioMet | ---------- |
The proposed AcuMatch L-Series Unipolar Endoprosthesis has the same basic external design features as our predicate Exactech Opteon Endoprosthesis. These features include a material composition of cobalt chrome and identical off set sizing options. The main difference between the two designs is that the predicate Opteon model is a one-piece component and the L-Series model is a modular device with interchangeable neck segments.
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510(k) Summary of Safety and Effectiveness Special 510(k)
In addition, the proposed L-Series Unipolar Endoprosthesis provides features similar to models marketed by Smith & Nephew, Howmedica and Biomet.
All the components have a spherical design, are made of cobalt chrome and supplied sterile.
Device Description:
The AcuMatch L-Series Unipolar is a modular endoprosthesis consisting of a truncated The Tical head and interchangeable neck sleeves. The device is fully machined from sphortour nead and filtering to ASTM F1537-94. The size offerings include 15 head sizes (38 mm - 62 mm) with four available offset options (-5, +0, +5 and +10).
Selection of the Acumatch Unipolar component is made by the surgeon in relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the rechnique of implayation of the prosthesis by: 1) appropriate reading of the literature and 2) training in the operative skills and techniques required for hip arthroplasty surgeries.
INTENDED USE
The AcuMatch L-Series Unipolar Endoprosthesis was designed to address the more conservative clinical indications for joint replacement surgery. The L-Series Unipolar modular head is used in hemiarthroplasty of the hip. If total joint replacement is required at a future time, the procedure can be accomplished without removing the femoral stem.
INDICATIONS
The AcuMatch L-Series Unipolar Endoprosthesis is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture.
CONTRAINDICATIONS
The AcuMatch L-Series Unipolar Endoprosthesis 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 of the system. The L-Series Unipolar is also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.
Section 4 Page 3 of 4
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510(k) Summary of Safety and Effectiveness Special 510(k)
Packaging Information:
| Material | Composition |
|---|---|
| Inner / Outer Trays | PETG - 0.040" thickness |
| Tray Lids | Spun-Bonded Olefin - Tyvek® |
| Inserts | Medium grade LD45 Foam |
| Box | Heavy weight cardboard |
| Outer Shrink-Wrap | Clear, Light-Weight Plastic |
| Shipping Cartons | Heavy-weight Corrugated Cardboard |
Utilization and implantation instructions are included in the package insert provided with each product. The name, size, dimension, material, lot, serial number and sterility status are indicated on the labeling.
Sterilization Specifications:
Method: Gamma radiation (Cobalt 60 source) Dose: 25 - 37 kGy Sterility Assurance Level (SAL): 10-6
Performance Data Summary:
Functional testing and engineering analysis were conducted to verify that the implant performance would be adequate for anticipated in vivo loading. Based on Finite Element Analysis (FEA), fatigue testing of production quality parts, and material certifications we conclude that the Exactech AcuMatch L-Series Unipolar Endoprosthesis is substantially equivalent to our predicate Exactech Opteon Unipolar device (#K960538).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the text "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
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FEB - 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Simpson Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653
Re: K010081
Trade Name: Exactech® AcuMatch™ L-series Unipolar Endoprosthesis Regulatory Class: II Product Code: KWY Dated: January 8, 2001 Received: January 10, 2001
Dear Ms. Simpson:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your became is substantially equivalent (for the indications for use above and we nave determined the worketed in interstate commerce prior to May 28, 1976, the stated in the encrosure) to device Amendments, or to devices that have been reclassified in enacificin cate of the Modical Dories Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mainer the act include requirements for annual registration, listing of devices, Controlls of the rice free heeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remance ripproval), in they or says of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes 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. Failure to mspotwarity also 2007 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket I 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.
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Ms. Lisa Simpson
If you desire specific advice for your device on our labeling regulation (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 premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
L. Mark N. Milliken
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
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Indications for Use
510(k) Number:
K01008/
Device Name:
Exactech® AcuMatch™ Integrated Hip System L-Series Unipolar Endoprosthesis
INDICATIONS
The AcuMatch L-Series Unipolar Endoprosthesis is indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, osteonecrosis. rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for use in replacement of the femoral head following femoral neck fracture.
CONTRAINDICATIONS
The AcuMatch L-Series Unipolar Endoprosthesis 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 ioint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system. The L-Series Unipolar is also contraindicated for use in patients with evidence of degenerative changes in the acetabulum and/or pelvic fractures.
Concurrence of CDRH, Office of Device Evalu (Division Sign-Off) Division of General Restorative Devices 510(k) Number Prescription Use or Over the Counter Use 人
Please do not write below this line - use another page if needed.
Section 3 Page 1 of 1
§ 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.