(260 days)
No
The description focuses on the materials and mechanical properties of the knee implant components and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a knee implant system indicated for the reduction or relief of pain and/or improved knee function in patients with severe knee pain and disability due to various arthritic conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The U2 Total Knee System - PF+ is an orthopedic implant for knee replacement, not a device used to diagnose medical conditions. Its intended use is to reduce pain and improve knee function in patients with severe knee pain and disability, which is a therapeutic purpose.
No
The device description clearly outlines physical components made of metal alloys (Co-Cr-Mo, titanium alloy) intended for surgical implantation, which are hardware, not software.
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 detect diseases, conditions, or infections.
- Device Description: The U2 Total Knee System - PF+ is a prosthetic implant designed to replace damaged knee joints. It is made of metal components (Femoral Component, Tibial Baseplate, and Tibial Extension Stem) that are surgically implanted into the patient's body.
- Intended Use: The intended use clearly states that the device 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 sample outside the body.
The information provided describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
U2 Total Knee System- PF+ 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, 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 deformities. 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. Femoral Component, PF+, Tibial Baseplate, PF+ and Tibial Extension Stem are indicated for both cemented and cementless use.
Product codes
MBH, JWH
Device Description
There are three components included in U2 Total Knee System- PF+ for this 510k, (1)Femoral Component, PF+, (2)Tibial Baseplate, PF+, and (3)Tibial Extension Stem. Both Femoral Component, PF+ and Tibial Baseplate, PF+ can collocate with U2 Total Knee System tibial insert and patellar component (K021657, K051640, K082469, K103733, K131864, K132752, K150829, K152430, K161705, and K210961). This system includes Cruciate Retained (CR) type and Posterior Stabilized (PS) type.
• Femoral Component, PF+
There are two types of Femoral Component, PF+ : Cruciate Retaining type and Posterior Stabilized type. Femoral Component, PF+ is manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The inner surface is coated with Co-Cr-Mo beads and Co-Cr-Mo powder (ASTM F75) to provide a porous surface to achieve biological fixation.
• Tibial Baseplate, PF+
Tibial Baseplate, PF+ is manufactured from titanium alloy (ASTM F620) which is forged by titanium alloy bars (ASTM F136). The backside of the subject device is coated with Titanium powder (ASTM F1580).
• Tibial Extension Stem
Tibial Extension Stem is collocated with tibial baseplate. The subject device is made of titanium alloy conforming to ASTM F136.
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 rationale 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.
• Femoral component fatigue test
• Tibial baseplate fatigue test
• Articulating surface finish of femoral component
• Finish of non-articulating surface of tibial baseplate
• Microstructure of the modified surface
• Mechanical properties of the modified surface
• Bacteria endotoxin testing was conducted and met the endotoxin limit as specified in USP
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K051640, K120507, K150829, K181794, K123486, K162256, K140942, K190100, K151316
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
February 28, 2023
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
United Orthopedic Corporation Cheryl Wagoner Official Correspondent 5215 Crosswinds Drive Wilmington, North Carolina 28409
Re: K221705
Trade/Device Name: U2 Total Knee System-PF+ Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH. JWH Dated: January 30, 2023 Received: January 31, 2023
Dear Cheryl Wagoner:
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 -S
Ting Song, Ph.D. 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)
Device Name
U2 Total Knee System- PF+
U2 Total Knee System - PF+ 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, 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 deformities. 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. Femoral Component, PF+, Tibial Baseplate, PF+ and Tibial Extension Stem are indicated for both cemented and cementless use.
| l ype of Ose (Select one of Dolf), as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C) | ||||
|---|---|---|---|---|
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| information unless it disnlays a currently valid OMB number " |
PSC Publishing Services (301) 443-6740
EF
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U2 Total Knee System, PF+
Traditional 510 (k)
510(K) SUMMARY Traditional 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 | June 10, 2022 |
Trade Name, Common Name, Classification
| Device Common Name: | Femoral component, Tibial baseplate, Tibial stem | |
|---|---|---|
| Trade name: | U2 Total Knee System- PF+ | |
| Submitter Establishment Number: | 9681642 | |
| Classification Regulation Number: | 21CFR 888.3565 | |
| Classification Panel: | Orthopedic | |
| Product Code: | MBH, JWH | |
| Device Class: | Class II | |
| Classification name: | Knee joint patellofemorotibial metal/polymer porous- | |
| coated uncemented prosthesis |
Predicate devices
| Primary Predicate | ||
|---|---|---|
| Product name | Manufacturer | 510(k) Number |
| U2 Femoral Component, CR, Porous | ||
| Coated | United Orthopedic Corporation | K140075, K150832 |
| Predicate or Reference Device | ||
| U2 Total Knee System | United Orthopedic Corporation | K051640, K120507, |
| K150829 | ||
| Truliant® Porous Femoral Components | Exactech | K181794 |
| Triathlon® Tritanium Tibial Baseplates | Stryker | K123486 |
| Klassic® Tibial Baseplate, Porous | Total Joint Orthopedics | K162256 |
| Klassic™ Knee Tibial Stem Extension | Total Joint Orthopedics | K140942 |
| USTAR II Knee System | United Orthopedic Corporation | K190100 |
| U2 Hip stem, Ti porous coated, matrix | United Orthopedic Corporation | K151316 |
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| Device description | There are three components included in U2 Total Knee System- PF+ for this
510k, (1)Femoral Component, PF+, (2)Tibial Baseplate, PF+, and (3)Tibial
Extension Stem. Both Femoral Component, PF+ and Tibial Baseplate, PF+ can
collocate with U2 Total Knee System tibial insert and patellar component
(K021657, K051640, K082469, K103733, K131864, K132752, K150829,
K152430, K161705, and K210961). This system includes Cruciate Retained
(CR) type and Posterior Stabilized (PS) type. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Femoral Component, PF+
There are two types of Femoral Component, PF+ : Cruciate Retaining type and
Posterior Stabilized type. Femoral Component, PF+ is manufactured from cast
Co-Cr-Mo alloy conforming to ASTM F75. The inner surface is coated with Co-
Cr-Mo beads and Co-Cr-Mo powder (ASTM F75) to provide a porous surface to
achieve biological fixation. |
| | • Tibial Baseplate, PF+
Tibial Baseplate, PF+ is manufactured from titanium alloy (ASTM F620) which
is forged by titanium alloy bars (ASTM F136). The backside of the subject device
is coated with Titanium powder (ASTM F1580). |
| | • Tibial Extension Stem
Tibial Extension Stem is collocated with tibial baseplate. The subject device is
made of titanium alloy conforming to ASTM F136. |
| Indications for use | U2 Total Knee System - PF+ 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
deformities. 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. Femoral Component, PF+, Tibial
Baseplate, PF+ and Tibial Extension Stem are indicated for both cemented and
cementless use. |
| Technological
Characteristics | The Subject device fundamental scientific principles and technological
characteristics, including: the intended use, material and general design, are the |
| | same as, or similar to, the primary predicate and the chosen additional
predicate/reference devices.
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 predicates. |
| | 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 rationale 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.
• Femoral component fatigue test
• Tibial baseplate fatigue test
• Articulating surface finish of femoral component
• Finish of non-articulating surface of tibial baseplate
• Microstructure of the modified surface
• Mechanical properties of the modified surface
• Bacteria endotoxin testing was conducted and met the endotoxin limit as
specified in USP |
| Conclusion | Based upon equivalences in: intended use, patient population, site of application,
conditions of use, operating principles, and the non-clinical performance data,
the Subject device has been shown to be safe and effective and to perform
equivalently as compared to the legally marketed predicate devices.
Therefore, the Subject devices are substantially equivalent to the legally
marketed predicate devices. |
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