(269 days)
No
The summary describes a knee implant system and its mechanical performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for knee arthroplasty to reduce or relieve pain and/or improve knee function in patients with severe knee pain and disability due to various conditions, which are therapeutic benefits.
No
This device is a surgical implant (tibial insert and patella) used in knee arthroplasty to replace damaged joint components, not to diagnose a condition. Its intended use is for the reduction or relief of pain and improved knee function.
No
The device description clearly states it includes physical components (E-XPE Tibial insert and E-XPE Patella) which are implants for knee arthroplasty. The performance studies also focus on mechanical properties and wear simulation of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a knee implant used in surgical procedures (knee arthroplasty) to replace damaged joint components. Its purpose is to restore function and reduce pain within the body, not to analyze samples taken from the body.
- Performance Studies: The performance studies listed are related to the mechanical properties and function of the implant itself (range of motion, contact pressure, wear, fatigue), not to the analysis of biological samples.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For E-XPE Insert (CR, PS and UC type) and Patella:
The device 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, 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.
For E-XPE Insert (PSA type)
This device 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, 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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. This device is a single use implant and intended use only.
Product codes
JWH, OIY, MBH
Device Description
The subjected device includes E-XPE Tibial insert (CR, PS, UC and PSA type) and E-XPE Patella. It is an extension to the previously cleared "UNITED" U2 Total Knee System (K082424, K103733, K131864, K132752 and K150829). The design rationale and indication for use are identical to the previously cleared "UNITED" U2 Total Knee System.
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
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.
- Tibiofemoral Range of Motion (ROM) Analysis a.
- Contact Area and Contact Pressure on Femorotibial Joint b.
- Constraint of Femoroltibial Joint c.
- Locking Strength of Tibial Insert d.
- Wear Simulation Test e.
- Fatigue Test of Tibial Insert Spine
Mechanical Properties of E-XPE Material g.
Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP .
Clinical Performance Data/Information
None provided as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K051640, K103733, K131864, K132752, K150829, K082424, K120038, K943462, K961685, K113550
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2017
United Orthopedic Corporation Karen Ho Regulatory Affairs Manager No 57, Park Ave 2 Science Park Hsinchu, 300 TW
Re: K161705 Trade/Device Name: U2 Total Knee System E-XPE Products Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY, MBH Dated: February 9, 2017 Received: February 13, 2017
Dear Ms. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161705
Device Name
U2 Total Knee System E-XPE Products
Indications for Use (Describe)
For E-XPE Insert (CR, PS and UC type) and Patella:
The device 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, 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 patellectorny, 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.
For E-XPE Insert (PSA type)
Type of Use (Select one or hoth, as annlicable)
This device 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, 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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. This device is a single use implant and intended use only.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| -- | ------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- |
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3
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 | Karen Ho | |
| Regulation and Document Management | ||
| Date prepared | June 15, 2016 | |
| Name of Device | ||
| Trade Name | U2 Total Knee System E-XPE Products | |
| Common Name | Total Knee Prosthesis | |
| Regulation Name and | ||
| Number | "Knee joint patellofemorotibial polymer/metal/polymer | |
| semi-constrained cemented prosthesis." under 21CFR §888. | ||
| 3560 | ||
| "Knee joint patellofemorotibial metal/polymer porous-coated | ||
| uncemented prosthesis." under 21CFR §888. 3565 | ||
| Device Class | Class II | |
| Classification Panel | Orthopaedics | |
| Product Code | JWH, OIY, MBH | |
| Predicate Device | 1. U2 Total Knee System- Insert and Patella (K051640, | |
| K103733, K131864, K132752 and K150829), United | ||
| Orthopedic Corporation. | ||
| 2. U2 Total Knee System-PSA Type (K082424), United | ||
| Orthopedic Corporation. | ||
| 3. A200 Knee System (K120038), Renovis Surgical | ||
| Technologies. | ||
| 4. PFC Sigma" Knee System (K943462, K961685), Depuy | ||
| 5. Vanguard DCM Convetional Tibial Bearings (K113550), | ||
| Biomet |
Page: 7-1/4
4
Device Description:
The subjected device includes E-XPE Tibial insert (CR, PS, UC and PSA type) and E-XPE Patella. It is an extension to the previously cleared "UNITED" U2 Total Knee System (K082424, K103733, K131864, K132752 and K150829). The design rationale and indication for use are identical to the previously cleared "UNITED" U2 Total Knee System.
Indications for Use:
For E-XPE Insert (CR, PS and UC type) and Patella:
The device 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.
For E-XPE Insert (PSA type)
This device 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 contraction. This device is intended for use in patients who require augmentation and/or stem extensions due to
Page: 7-2/4
5
510(k) Summary
inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue imbalance. This device is a single use implant and intended for cemented use only.
Comparison to Predicate Device:
The design rationale and indication for use are identical to the previously cleared "UNITED" U2 Total Knee System (K082424, K103733, K131864, K132752 and K150829). The E-XPE material is substantially equivalent to "Renovis Surgical Technologies" A200 Knee System (K120038). The using instruments are also identical to the predicate devices.
The differences between the subject and the predicate devices are size distribution, device dimension and material. The performance evaluation of the subject device was conducted and would not post issues about safety and effectiveness. Thus, we believe that the subjected device is substantially equivalent to predicate devices.
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.
- Tibiofemoral Range of Motion (ROM) Analysis a.
- Contact Area and Contact Pressure on Femorotibial Joint b.
- Constraint of Femoroltibial Joint c.
- Locking Strength of Tibial Insert d.
- Wear Simulation Test e.
- Fatigue Test of Tibial Insert Spine ি
6
510(k) Summary
Mechanical Properties of E-XPE Material g.
Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP .
● Clinical Performance Data/Information
None provided as a basis for substantial equivalence.