(29 days)
No
The summary describes a mechanical knee implant and its components, with no mention of software, algorithms, or any technology that would suggest AI/ML is involved.
Yes
The device is indicated for "reduction or relief of pain and/or improved knee function," which aligns with the definition of a therapeutic device designed to treat or alleviate symptoms of a disease or condition.
No
The device is a knee implant designed for arthroplasty, which is a therapeutic intervention to replace the knee joint and alleviate pain and improve function. It does not diagnose medical conditions.
No
The device description clearly states that the device consists of physical components (Femoral components, patella components, Tibial baseplate components, and Tibial inserts components) designed for surgical implantation. It also mentions the use of orthopedic instrumentation. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a component for knee arthroplasty (joint replacement surgery) to alleviate pain and improve function in patients with various knee conditions. This is a surgical implant, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the components of a total knee replacement system (femoral, patella, tibial baseplate, and tibial insert). These are physical implants designed to replace parts of the knee joint.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a surgical implant used directly in the patient's body to treat a physical condition.
N/A
Intended Use / Indications for Use
For Tibial baseplate, CMA, #0 This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketetally 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 joint surfaction or prior patellectorny, moderate valgus, varus, or flexion contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.
For Tibial insert, #0 The device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketally 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.
Product codes
JWH
Device Description
The U2 Total Knee System consists of Femoral components, patella components, Tibial baseplate components and Tibial inserts components which are designed to be used together to achieve total replacement of the knee joint. This system includes Cruciate Retained (CR) type, Ultracongruent (UC) type, and Posterior Stabilized (PS) type.
The U2 Total Knee System, Tibial baseplate, CMA, #0 (Subject device) is a size extension of the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1 to #7 (K131864). The materials, indications, sterilization of this subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1 to #7 (K131864).
The U2 Total Knee System, Tibial insert, #0 (Subject device) is a size extension of the cleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The materials, indications, sterilization of this subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The Subject Tibial insert, CR, #0 and Tibial insert, PS, #0 have a more concave sagittal plane design while comparing to the marketed predicate devices
Surgical procedures with the use of the Subject device shall be performed with the support of orthopedic instrumentation, to facilitate their proper insertion and removal from the patient. All the surgical instruments have been cleared as part of the predicate devices.
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)
Based on the modification items of the design rational of the Subject device, the following non-clinical tests were conducted to evaluate the safety and effectiveness of the subjected device, and the test results indicated that this device is safe and effective. Range of Motion Locking Strength of Tibial baseplate and Insert Contact Area and Contact Pressure Wear Simulation Test Fatigue Test of Tibial baseplate Spine Fatigue Test of Tibial insert The clinical tests was not deemed necessary for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K131864, K051640, K150829, K103733, K132752, K161705
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 6, 2022
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu, 30075 TAIWAN
Re: K222700
Trade/Device Name: Tibial baseplate, Tibial insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 2, 2022 Received: September 7, 2022
Dear Lois 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D. RAC Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222700
Device Name Tibial baseplate, Tibial insert
Indications for Use (Describe)
For Tibial baseplate, CMA, #0
This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketetally 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 joint surfaction or prior patellectorny, moderate valgus, varus, or flexion contraction. This device may also be indicated in the salvage or previously failed surgical attempts or for knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. This device system is designed for cemented use only.
For Tibial insert, #0
The device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in sketally 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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Special 510 (k)
510(K) SUMMARY Special 510(k)
[as required by 21 CFR 807.92(c)]
Submitter information
| Company Name: | United Orthopedic Corporation |
|---|---|
| Address | No 57, Park Ave 2, Science Park, Hsinchu City 30075, Taiwan |
| Telephone | +886-3-5773351 ext. 2220 |
| Fax | +886-3-577156 |
| Contact Person | Lois Ho, Regulatory Affairs Manager |
|---|---|
| Email address | lois.ho@unitedorthopedic.com |
| Date of submission | September 02 2022 |
Trade Name, Common Name, Classification
| Device Common Name: | Tibial baseplate, Tibial insert |
|---|---|
| Trade name: | U2 Total Knee System, #0 |
| Submitter Establishment Number: | 9681642 |
| Classification Regulation Number: | 21CFR 888.3560 |
| Classification Panel: | Orthopedic |
| Product Code: | JWH |
| Device Class: | Class II |
| Classification name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained |
| cemented prosthesis per 21CFR 888.3560. This falls under the | |
| Orthopedics panel. |
Predicate devices
| Predicate | 510(k) Number | Manufacturer |
|---|---|---|
| 1. U2 Tibial baseplate, CMA | 1. K131864 | United |
| 2. Tibial insert, CR and PS type | 2. K051640, K150829, K131864 | Orthopedic |
| 3. XPE Tibial insert, CR and PS type | 3. K103733, K150829, K131864 | Corporation |
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| U2 Total Knee System #0 | Special 510 (k) | ||||
|---|---|---|---|---|---|
| 4. | XPE Tibial insert, UC type | 4. | K132752, K150829 | ||
| 5. | E-XPE Tibial insert, CR and UC and PS type | 5. | K161705 |
| Device description | The U2 Total Knee System consists of Femoral components, patella components, Tibial
baseplate components and Tibial inserts components which are designed to be used
together to achieve total replacement of the knee joint. This system includes Cruciate
Retained (CR) type, Ultracongruent (UC) type, and Posterior Stabilized (PS) type. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The U2 Total Knee System, Tibial baseplate, CMA, #0 (Subject device) is a size
extension of the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1
to #7 (K131864). The materials, indications, sterilization of this subject are identical to
the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1 to #7
(K131864). |
| | The U2 Total Knee System, Tibial insert, #0 (Subject device) is a size extension of the
cleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733,
K131864, K132752, K150829 and K161705). The materials, indications, sterilization of
this subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial insert,
#1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The Subject
Tibial insert, CR, #0 and Tibial insert, PS, #0 have a more concave sagittal plane design
while comparing to the marketed predicate devices |
| | Surgical procedures with the use of the Subject device shall be performed with the
support of orthopedic instrumentation, to facilitate their proper insertion and removal
from the patient. All the surgical instruments have been cleared as part of the predicate
devices. |
5
| U2 Total Knee System #0 | Special 510 | |
|---|---|---|
| Indications for use | For Tibial baseplate, CMA, #0 | |
| 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 joint surface erosion, dysfunction or | ||
| prior patellectomy, moderate valgus, varus, or flexion contraction. This device | ||
| may also be indicated in the salvage or previously failed surgical attempts or for | ||
| knee in which satisfactory stability in flexion cannot be obtained at the time of | ||
| surgery. This device system is designed for cemented use only. |
For Tibial insert, #0
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. | |
| Technological
Characteristics | The Subject device fundamental scientific principles and technological characteristic,
including: the intended use, material and general design, are the same as, or similar to,
the primary predicate and the chosen additional predicate device.
Summary of the technological characteristics:
✓ Intended use: identical
✓ Indications for Use, Anatomical sites, operating principles and conditions of use
are identical
✓ No new risks associated to the Subject device compared to those of the predicate
devices.
✓ Verification activities on Subject devices demonstrated equivalent safety and
effectiveness as compared to the predicate devices. | |
| U2 Total Knee System #0 | | Special 510 (k) |
| | ✓ Material: identical. | |
| | ✓ Geometry and size: The size of the subject subject, which owns the smallest
diameter, are the extension size of the primary predicates. | |
| | ✓ Sterilization: identical method as predicate. | |
| | The technological characteristics of the Subject device are substantially equivalent to
the predicate devices. | |
| Performance
Analysis | Based on the modification items of the design rational of the Subject device, the
following non-clinical tests were conducted to evaluate the safety and effectiveness of
the subjected device, and the test results indicated that this device is safe and effective. Range of Motion Locking Strength of Tibial baseplate and Insert Contact Area and Contact Pressure Wear Simulation Test Fatigue Test of Tibial baseplate Spine Fatigue Test of Tibial insert The clinical tests was not deemed necessary for the subject device. | |
| Conclusion | Based upon equivalences in: intended use, patient population, site of application,
conditions of use, operating principles, and the non-clinical performance data, the
changes introduced in the Subject device have been shown to be safe and effective and
to perform equivalently as compared to the legally marketed predicate devices.
Therefore, the changes to primary predicate for Subject devices are substantially
equivalent to the legally marketed predicate devices. | |
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