(179 days)
No
The summary describes a knee implant and its mechanical properties, with no mention of AI or ML.
Yes
The device is a knee arthroplasty system intended for the reduction or relief of pain and/or improved knee function, which directly addresses a medical condition to restore health.
No
The device is a knee implant (prosthesis) used for knee arthroplasty, which is a surgical treatment for severe knee pain and disability. It is not used to diagnose a condition, but rather to treat it.
No
The device description clearly states it is a "Femoral Component," which is a physical implant used in knee arthroplasty. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the U2 Total Knee system is indicated for use in knee arthroplasty to address pain and improve function in patients with various knee conditions. This is a surgical implant used in vivo (within the body).
- Device Description: The device is described as a femoral component for a total knee system, which is a physical implant.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such tests on specimens.
The information provided describes a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cementless use only.
Product codes
MBH
Device Description
U2 Femoral Component, CR, Porous Coated, Additional Sizes is an extension of cleared "UNITED" U2 Femoral Component, CR, Porous Coated (K140075). The indications, major design features, materials, major manufacture processing and methods of this subject are identical to the cleared U2 Femoral Component, CR, Porous Coated (K140075). The cleared femoral components are available in size #1, #2, #3, #7, and the subjected femoral components are the intermediate sizes for #1.5, #2.5, #4.5, #5.5 and #6.5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Skeletally mature patients
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
The mechanical properties of the intermediated sizes have been evaluated to conform to FDA guidance: "Class II Special Controls Guidance Document: Knee Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses." The analysis results demonstrate that the adding intermediate sizes would not affect the safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2015
United Orthopedic Corporation Fang-Yuan Ho Regulatory Affairs Manager Number 57, Park Avenue 2, Science Park Hsinchu 300 Taiwan
Re: K150832
Trade/Device Name: U2 Femoral Component, CR, Porous Coated, Additional Sizes Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: March 20, 2015 Received: March 30, 2015
Dear Fang-Yuan Ho:
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
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Page 2 - Fang-Yuan Ho
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication for Use
K150832 510 (k) Number (if known):
Device Name: U2 Femoral Component, CR, Porous Coated, Additional Sizes
Indications for Use:
The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cementless use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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(9) U2 Femoral Component, CR, Porous Coated, Additional Sizes 510(k) Summary
510(k) Summary of Safety and Effectiveness
| Submitted by: | United Orthopedic Corporation |
|---|---|
| Address: | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan |
| Phone Number: | +886-3-5773351 ext. 2212 |
| Fax Number: | +886-3-577156 |
| Date of Summary: | March 11, 2015 |
| Contact Person | Fang-Yuan Ho |
| Regulation and Document Management Manager | |
| Proprietary Name: | U2 Femoral Component, CR, Porous Coated, Additional Sizes |
| Common Name: | Total Knee Prosthesis |
| Device Classification | Knee joint patellofemorotibial metal/polymer porous-coated |
| Name and Reference: | uncemented prosthesis under 21CFR 888. 3565 |
| This falls under the Orthopedics panel. | |
| Device Class | Class II |
| Panel Code | Orthopaedics Device |
| Device Product Code: | MBH |
| Predicate Device: | "UNITED" U2 Femoral Component, CR, Porous Coated |
| (K140075) |
Device Description:
U2 Femoral Component, CR, Porous Coated, Additional Sizes is an extension of cleared "UNITED" U2 Femoral Component, CR, Porous Coated (K140075). The indications, major design features, materials, major manufacture processing and methods of this subject are identical to the cleared U2 Femoral Component, CR, Porous Coated (K140075). The cleared femoral components are available in size #1, #2, #3, #7, and the subjected femoral components are the intermediate sizes for #1.5, #2.5, #4.5, #5.5 and #6.5.
4
U2 Femoral Component, CR, Porous Coated, Additional Sizes 510(k) Summary
Indications:
The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cementless use only.
Basis for Substantial Equivalence:
The indications, materials, geometry and sterilization method of subjected device are identical to the predicate device "UNITED" U2 Femoral Component, CR, Porous Coated (K140075).
Performance Data:
The mechanical properties of the intermediated sizes have been evaluated to conform to FDA guidance: "Class II Special Controls Guidance Document: Knee Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses." The analysis results demonstrate that the adding intermediate sizes would not affect the safety and effectiveness.