(29 days)
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.
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.
This is a medical device clearance, not an AI/ML device. Therefore, the questions regarding AI/ML device evaluations (sample size, experts, adjudication, MRMC, standalone performance, ground truth establishment for training set, etc.) are not applicable.
The document describes the acceptance criteria and study for a Tibial baseplate and Tibial insert, which are components of a knee replacement system. This is a traditional medical device, not an AI/ML powered device. Therefore, the concepts related to AI/ML device performance such as ground truth, expert adjudication, train/test sets, effect size of AI assistance, etc., are not relevant to this document.
However, I can extract the information provided regarding the device's performance analysis and acceptance criteria, based on the non-clinical tests conducted.
Here's the summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list 'acceptance criteria' with numerical targets and then 'reported device performance' side-by-side in a table format. Instead, it states that "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." This implies that the device met the internal acceptance criteria for each test.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied by Conclusion) |
|---|---|
| Range of Motion | Met Safety and Effectiveness requirements |
| Locking Strength of Tibial baseplate and Insert | Met Safety and Effectiveness requirements |
| Contact Area and Contact Pressure | Met Safety and Effectiveness requirements |
| Wear Simulation Test | Met Safety and Effectiveness requirements |
| Fatigue Test of Tibial baseplate | Met Safety and Effectiveness requirements |
| Spine Fatigue Test of Tibial insert | Met Safety and Effectiveness requirements |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes (number of devices tested) for the non-clinical tests. It also does not provide information about data provenance as these are laboratory-based mechanical tests, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a mechanical device, not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a mechanical device. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or AI/ML ground truth establishment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a mechanical device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For mechanical devices, "ground truth" is typically defined by engineering specifications, material properties, and mechanical test standards (e.g., ISO or ASTM standards) that define acceptable performance limits. The document states that the "non-clinical tests were conducted to evaluate the safety and effectiveness," implying adherence to established engineering and material science principles, but specific ground truth definition is not explicitly detailed in this summary.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device, not an AI/ML device.
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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
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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-constrainedcemented prosthesis per 21CFR 888.3560. This falls under theOrthopedics 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, Tibialbaseplate components and Tibial inserts components which are designed to be usedtogether to achieve total replacement of the knee joint. This system includes CruciateRetained (CR) type, Ultracongruent (UC) type, and Posterior Stabilized (PS) type. |
|---|---|
| The U2 Total Knee System, Tibial baseplate, CMA, #0 (Subject device) is a sizeextension of the cleared "UNITED" U2 Total Knee System, Tibial baseplate, CMA, #1to #7 (K131864). The materials, indications, sterilization of this subject are identical tothe 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 thecleared "UNITED" U2 Total Knee System, Tibial insert, #1 to #7 (K051640, K103733,K131864, K132752, K150829 and K161705). The materials, indications, sterilization ofthis subject are identical to the cleared "UNITED" U2 Total Knee System, Tibial insert,#1 to #7 (K051640, K103733, K131864, K132752, K150829 and K161705). The SubjectTibial insert, CR, #0 and Tibial insert, PS, #0 have a more concave sagittal plane designwhile comparing to the marketed predicate devices | |
| Surgical procedures with the use of the Subject device shall be performed with thesupport of orthopedic instrumentation, to facilitate their proper insertion and removalfrom the patient. All the surgical instruments have been cleared as part of the predicatedevices. |
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| U2 Total Knee System #0 | Special 510 | |
|---|---|---|
| Indications for use | For Tibial baseplate, CMA, #0This device is indicated in knee arthroplasty for reduction or relief of pain and/orimproved knee function in skeletally mature patients with severe knee pain anddisability due to rheumatoid arthritis, osteoarthritis, primary and secondarytraumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of thefemoral condyle or pseudogout, posttraumatic loss of joint configuration,particularly when there is patellofemoral joint surface erosion, dysfunction orprior patellectomy, moderate valgus, varus, or flexion contraction. This devicemay also be indicated in the salvage or previously failed surgical attempts or forknee in which satisfactory stability in flexion cannot be obtained at the time ofsurgery. This device system is designed for cemented use only.For Tibial insert, #0The device is indicated in knee arthroplasty for reduction or relief of pain and/orimproved knee function in skeletally mature patients with severe knee pain anddisability due to rheumatoid arthritis, osteoarthritis, primary and secondarytraumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of thefemoral condyle or pseudogout, posttraumatic loss of joint configuration,particularly when there is patellofemoral erosion, dysfunction or priorpatellectomy, moderate valgus, varus, or flexion deformities. This device mayalso be indicated in the salvage of previously failed surgical attempts if the kneecan be satisfactorily balanced and stabilized at the time of surgery. This device isa single use implant and intended for cemented use only. | |
| TechnologicalCharacteristics | 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 useare identical✓ No new risks associated to the Subject device compared to those of the predicatedevices.✓ Verification activities on Subject devices demonstrated equivalent safety andeffectiveness 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 smallestdiameter, are the extension size of the primary predicates. | ||
| ✓ Sterilization: identical method as predicate. | ||
| The technological characteristics of the Subject device are substantially equivalent tothe predicate devices. | ||
| PerformanceAnalysis | Based on the modification items of the design rational of the Subject device, thefollowing non-clinical tests were conducted to evaluate the safety and effectiveness ofthe 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, thechanges introduced in the Subject device have been shown to be safe and effective andto perform equivalently as compared to the legally marketed predicate devices.Therefore, the changes to primary predicate for Subject devices are substantiallyequivalent to the legally marketed predicate devices. |
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§ 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.