(179 days)
No
The summary describes a knee implant system and its components, focusing on materials, dimensions, and mechanical performance testing. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The device is a physical implant, not a software or imaging-based system.
Yes
The device is indicated for the reduction or relief of pain and/or improved knee function, which are therapeutic outcomes.
No
This device is a total knee system, which is an implant used in knee arthroplasty to replace damaged knee joints. Its function is to reduce pain and improve knee function, not to diagnose a condition.
No
The device description explicitly states it includes physical components like femoral components and tibial inserts, which are hardware.
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 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 device is described as a system of components (femoral component, tibial insert) that are implanted into the body. IVDs are typically used to examine specimens (like blood, urine, or tissue) outside of the body.
- Performance Studies: The performance studies listed are related to the mechanical properties and function of the implant within the body (range of motion, contact pressure, fatigue testing). These are not studies related to diagnosing a condition.
An In Vitro Diagnostic (IVD) device is defined as a medical device that is used to perform tests on specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
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 cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
This subjected device includes femoral component, tibial insert, XPE tibial insert and ultracongruent insert. It is a size extension to the cleared "UNITED" U2 Total Knee System (K051640, K120507, K131864, K103733, K132752, and K140073). The indications, materials, design of this subject device are identical to the cleared "UNITED" U2 Total Knee System except for its dimension.
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: This 510(k) submission was prepared in accordance with the Agency's, "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and 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
- Contact Area and Contact Pressure on Femorotibial Joint
- Contact Area and Contact Pressure on Femoropatellar Joint
- Constraint of Femoroltibial Joint
- Fatigue Compression Test of Femoral Component
- Locking Strength of Tibial Insert
- Fatigue Performance of Tibial Insert Spine
- Materials Properties of U2 XPE Tibial Insert
Clinical Performance Data/Information: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K051640, K103733, K120507, K131864, K132752, K140073
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.
Not Found
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).
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
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: K150829 Trade/Device Name: U2 Total Knee System-Additional Sizes Regulation Number: 21 CFR 888.3650 Regulation Name: Knee joint patellofemorobial polymer/metal semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH 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
1
device-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/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
510 (k) Number (if known):
Device Name: U2 Total Knee System-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 cemented use only.
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ 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)
3
೪ U2 Total Knee System—Additional Sizes
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 | March 20, 2015 |
| Name of Device | |
| Trade Name | U2 Total Knee System—Additional Sizes |
| Common Name | Total Knee Prosthesis |
| Classification Name and | |
| Regulation | Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis under 21CFR §888. | |
| 3560 | |
| Device Class | Class II |
| Classification Panel | Orthopaedics |
| Product Code | JWH |
| Predicate Device | 1. “UNITED” U2 Total Knee System (K051640) |
- “UNITED” U2 XPE Total Knee System (K103733)
- “UNITED” U2 Femoral Component, PS, #7 (K120507)
- “UNITED” Tibial inserts, #7 (K131864)
- “UNITED” Ultracongruent Insert (K132752)
- “UNITED” U2 Femoral Component, CR, Cemented (K140073) |
Device Description:
This subjected device includes femoral component, tibial insert, XPE tibial insert and
4
0 U2 Total Knee System-Additional Sizes
510(k) Summary
ultracongruent insert. It is a size extension to the cleared "UNITED" U2 Total Knee System (K051640, K120507, K131864, K103733, K132752, and K140073). The indications, materials, design of this subject device are identical to the cleared "UNITED" U2 Total Knee System except for its dimension.
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 can be satisfactorily balanced and stabilized at the time of surgery. This device is a single use implant and intended for cemented use only.
Comparison to Predicate Device:
U2 Total Knee System, Additional Sizes has the same basic design, intended use, materials and the same manufacturing method as device of the "United" U2 Total Knee System (K051640, K120507, K131864, K103733, K132752 and K140073). The only difference between the cleared and subjected device is dimension.
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 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.
5
g U2 Total Knee System—Additional Sizes
- Range of Motion a.
- Contact Area and Contact Pressure on Femorotibial Joint b.
- Contact Area and Contact Pressure on Femoropatellar Joint c.
- Constraint of Femoroltibial Joint d.
- Fatigue Compression Test of Femoral Component e.
- Locking Strength of Tibial Insert f.
- Fatigue Performance of Tibial Insert Spine g.
- Materials Properties of U2 XPE Tibial Insert h.
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.