(21 days)
No
The summary describes a mechanical knee implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total knee system indicated for the reduction or relief of pain and/or improved knee function in patients with severe knee pain and disability, which aligns with the definition of a therapeutic device.
No
The device is a knee implant designed for surgical replacement of the knee joint, not for diagnosing medical conditions. Its intended use is to reduce pain and improve function in patients with severe knee issues.
No
The device description clearly states it includes physical components like femoral, patellar, and tibial components made of materials like UHMWPE, designed for surgical implantation. It also mentions the use of surgical instrumentation. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The U2 Total Knee System is a surgical implant designed to replace a damaged knee joint within the body. It is a physical component implanted during surgery.
- Intended Use: The intended use clearly states it is for "knee arthroplasty for reduction or relief of pain and/or improved knee function." This is a surgical procedure, not a diagnostic test performed on a specimen.
The information provided describes a medical device used for surgical intervention, not for in vitro diagnostic testing.
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, osteoarthitis, 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
JWH
Device Description
The U2 Total Knee System include femoral components, patellar 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, Posterior Stabilized (PS) type and Ultracongruent (UC) type. The subject device, U2 Total Knee System, XPE Tibial Insert, Posterior Stabilized PLUS (PS PLUS), belongs to U2 Total Knee System PS type.
U2 Total Knee System, XPE Tibial Insert, PS PLUS (Subject device) is a constrained design insert mechanically locked with metallic tibial baseplate. It is manufactured from Gamma irradiated UHMWPE which conform to ASTM F2565-13, while the UHMWPE raw material is in accordance with ASTM F648-14 and ISO 5834-1:2005.
The Subject device is used with the Posterior Stabilized (PS) type Femoral Component. In comparison to the marketed predicate devices, the Subject device has slightly modified width and height of the post, the height of the anterior lip. The Subject device provides constraint in varus/valgus and internal/external rotation to enhance joint stability and resist paradoxical anterior femoral slide.
Except for the differences of the post and anterior lip, the size distribution the Subject device is identical to the previously cleared Tibial Inserts of U2 Total Knee System predicates. The Subject device is available in eight proportional sizes (#0~ #7) and ten thicknesses (thicknesses of poly insert + tibial baseplate: 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm). The minimum thickness of poly insert of Subject device is 6 mm on the bearing surface, identical to the primary predicate.
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. The surgical instruments have been previously 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 joint
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 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.
Constraint evaluation Contact area and contact pressure analysis on femorotibial joint Tibiofemoral range of motion (ROM) analysis
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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April 21, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
United Orthopedic Corporation Lois Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu, 30075 TAIWAN
Re: K210961
Trade/Device Name: U2 Total Knee System, XPE Tibial Insert, PS PLUS Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 31, 2021 Received: March 31, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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., R.A.C. 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
2
Indications for Use
510(k) Number (if known)
Device Name
U2 Total Knee System, XPE Tibial Insert, PS PLUS
Indications for Use (Describe)
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, osteoarthitis, 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,
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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Image /page/3/Picture/1 description: The image shows the logo for United Orthopedic. The logo consists of a green letter U with a white circle inside, and the words "UNITED ORTHOPEDIC" in black text to the right of the U. The word "UNITED" is above the word "ORTHOPEDIC".
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 | March 30, 2021 |
Trade Name, Common Name, Classification
| Device Common Name: | Tibial Insert |
|---|---|
| Trade name: | U2 Total Knee System, XPE Tibial Insert, PS Plus |
| 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 |
Predicate devices and reference devices
| Primary Predicate | 510(k) Number | Manufacturer |
|---|---|---|
| U2 Total Knee System, Tibial Insert, PS | K150829 | United Orthopedic Corporation |
| Reference Predicate | ||
| U2 Total Knee System, Tibial Insert, PS | K103733, K131864, K161705 | United Orthopedic Corporation |
| Device description | The U2 Total Knee System include femoral components, patellar
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, |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Posterior Stabilized (PS) type and Ultracongruent (UC) type. The subject device, U2 Total Knee System, XPE Tibial Insert, Posterior Stabilized PLUS (PS PLUS), belongs to U2 Total Knee System PS type. | |
| U2 Total Knee System, XPE Tibial Insert, PS PLUS (Subject device) is a constrained design insert mechanically locked with metallic tibial baseplate. It is manufactured from Gamma irradiated UHMWPE which conform to ASTM F2565-13, while the UHMWPE raw material is in accordance with ASTM F648-14 and ISO 5834-1:2005. | |
| The Subject device is used with the Posterior Stabilized (PS) type Femoral Component. In comparison to the marketed predicate devices, the Subject device has slightly modified width and height of the post, the height of the anterior lip. The Subject device provides constraint in varus/valgus and internal/external rotation to enhance joint stability and resist paradoxical anterior femoral slide. | |
| Except for the differences of the post and anterior lip, the size distribution the Subject device is identical to the previously cleared Tibial Inserts of U2 Total Knee System predicates. The Subject device is available in eight proportional sizes (#0~ #7) and ten thicknesses (thicknesses of poly insert + tibial baseplate: 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm and 18mm). The minimum thickness of poly insert of Subject device is 6 mm on the bearing surface, identical to the primary predicate. | |
| 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. The surgical instruments have been previously cleared as part of the predicate devices. | |
| 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. |
| 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.
✓ Material: are identical to the primary predicate.
✓ Geometry and size: Sizes of the Subject device are bracketed in size by
the predicates.
✓ Sterilization: identical method as predicate.
The technological characteristics of the Subject device are substantially
equivalent to the predicate device(s). |
| Performance Analysis | Based on the modification items of the design rational of the Subject
device, the following 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.
Constraint evaluation Contact area and contact pressure analysis on femorotibial joint Tibiofemoral range of motion (ROM) analysis |
| 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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Image /page/4/Picture/1 description: The image shows the logo for United Orthopedic. The logo consists of a green circle with a white "U" shape inside, and the words "UNITED ORTHOPEDIC" in black text to the right of the circle. The word "ORTHOPEDIC" is stacked below the word "UNITED".
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Image /page/5/Picture/1 description: The image shows the logo for United Orthopedic. The logo consists of a green circular shape with a white dot inside, resembling the letter 'U'. To the right of the symbol, the words "UNITED" and "ORTHOPEDIC" are written in black, stacked on top of each other.