(151 days)
No
The 510(k) summary describes a traditional knee implant system and does not mention any AI or ML components, algorithms, or related functionalities. The performance studies are based on mechanical testing, not data-driven AI/ML performance metrics.
Yes
The device is a knee arthroplasty system indicated for reducing pain and improving knee function in patients with severe knee pain and disability due to various conditions, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a knee implant designed for arthroplasty, which is a surgical procedure to replace a joint, not to diagnose a condition.
No
The device description clearly states it is a physical implant (femoral component) made of Co-Cr-Mo alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a knee joint to alleviate pain and improve function in patients with various knee conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of metal alloys, designed to be surgically implanted into the body. This is consistent with a medical device, not an IVD which typically involves testing samples outside the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the mechanical properties and function of the implant (range of motion, contact pressure, fatigue), which are relevant to a surgical device, not an IVD.
In summary, the U2 Total Knee system is a surgical implant intended for therapeutic use in knee arthroplasty, not a device used for diagnosing diseases or conditions in vitro.
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 cannot be satisfactorily balanced and stabilized at the time of surgery.
For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.
For porous coated femoral component: This device is a single use implant and intended for cementless use only.
Product codes
MBH
Device Description
U2 Porous Coated Femoral Component-CR Type is manufactured from Co-Cr-Mo alloy confirming to ASTM F75. The inner surface is porous coated with Co-Cr-Mo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance:
- Range of Motion
- Contact Area and Contact Pressure on Femorotibial Joint
- Contact Area and Contact Pressure on Femoropatellar Joint
- Subluxation of Femoroltibial Joint
- Fatigue Compression Test of Femoral Component
The test results demonstrated that this device is safe and effective.
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
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
§ 888.3565 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
JUN 1 3 2014
0 U2 Femoral Component, CR, Porous Coated
510(k) Summary
510(k) Summary of Safety and Effectiveness
| Submitter Information | |
|---|---|
| Name | 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 |
| Name of Contact Person | Fang-Yuan Ho |
| Regulation and Document Management | |
| Date prepared | January 10, 2014 |
| Name of Device | |
| Trade Name | U2 Femoral Component, CR, Porous Coated |
| Common Name | Femoral Component |
| Classification Name and | Knee joint patellofemorotibial metal/polymer |
| Regulation | porous-coated uncemented prosthesis under 21CFR § |
| 888.3565 | |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | MBH |
| Predicate Device | 1. “United” U2 Total Knee System (K051640) |
- “Smith & Nephew” Genesis II Total Knee System (K030612) |
Device Description:
U2 Porous Coated Femoral Component-CR Type is manufactured from Co-Cr-Mo alloy confirming to ASTM F75. The inner surface is porous coated with Co-Cr-Mo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of
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U2 Femoral Component, CR, Porous Coated
cleared U2 Total Knee System (K051640), except adding size #7.
Intended 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 cannot be satisfactorily balanced and stabilized at the time of surgery.
For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.
For porous coated femoral component: This device is a single use implant and intended for cementless use only.
Comparison to Predicate Device:
U2 Porous Coated Femoral Component-CR Type has the same materials, design, manufacturing and sterilization method as the femoral component of "United" U2 Total Knee System (K051640), except adding size #7. Besides, the basic design, size distribution, intended use of the subjected device and the method of fixation are similar with the femoral component of "Smith & Nephew" Genesis II Total Knee System (K030612).
Performance Data:
· Non-clinical Performance
This 510(k) submission was prepared in accordance with the Agency's. " Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and
2
( U2 Femoral Component, CR, Porous Coated
510(k) Summary
Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA". Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective.
- Range of Motion a.
- · b. Contact Area and Contact Pressure on Femorotibial Joint
- Contact Area and Contact Pressure on Femoropatellar Joint C.
- d. Subluxation of Femoroltibial Joint
- Fatigue Compression Test of Femoral Component e.
- Clinical Performance Data/Information
None provided as a basis for substantial equivalence.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a human figure with outstretched arms, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 13, 2014
United Orthopedic Corporation Fang-Yuan Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu 300 Taiwan
K140075 Re:
Trade/Device Name: U2 Femoral Component, CR, Porous Coated 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 24, 2014 Received: March 25, 2014
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
4
related adverse events) (21 CFR 803); 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.
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 vours.
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510 (k) Number (if known): K140075
Device Name: U2 Femoral Component, CR, Porous Coated
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 cannot be satisfactorily balanced and stabilized at the time of surgery.
For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.
For porous coated femoral component: This device is a single use implant and intended for cementless use only.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (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)
Casey L Hanley, Ph, D. Division of Orthopedie Devices
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