(191 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, the U2 Total Knee System, is indicated for reducing or relieving pain and improving knee function in patients with severe knee pain and disability due to various conditions, which are therapeutic goals.
No
Explanation: This document describes a total knee replacement system, which is a prosthetic device for surgical implantation. It treats conditions rather than diagnosing them.
No
The device description clearly describes physical components (Ultracongruent Insert, tibial baseplate, Femoral Component) made of materials like UHMWPE and metal, indicating it 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 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: The provided text describes a surgical implant used to replace parts of the knee joint. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use clearly states it is for "knee arthroplasty" to reduce pain and improve function in patients with various knee conditions. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The description focuses on the physical characteristics, materials, and mechanical performance of the implant, which are typical for a surgical device, not an IVD.
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, 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 system is intended for cemented use only in the U.S.A.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Ultracongruent Insert is designed for the replacement of the bearing and/or articulating surfaces of the proximal tibia composed of an articulating bearing surface fixed in a metal tibial baseplate, and is used for patients with PCL incomplete, absent, nonfunctional or required release. It is used with the cruciate retained (CR) type Femoral Component. The anterior lip of Ultracongruent Insert is more prominent when comparing with the U2 CR Insert (K051640, K103733), which increases the articulating surface area and expands the circumference to accommodate and stabilize the femur during knee flexion. The Ultracongruent Insert is available in seven proportional sizes (#1~ #7) and five thicknesses (thicknesses of insert + tibial baseplate: 9mm, 11mm, 15mm, and 18mm). The minimum thickness of Ultracongruent Insert is 6 mm on the bearing surface. It is manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834.
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)
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.
- Constraint Test a.
- Contact Area and Contact Pressure b.
- Range of Motion c.
- d. Interlocking Strength Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K051640, K103733, K090705, K050222
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 1 3 2014
( Ultracongruent Insert
510(k) Summary
510(k) Summary of Safety and Effectiveness
| Submitted by: | 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 |
| Date of Summary: | August 16, 2013 |
| Contact Person | Fang-Yuan Ho |
| Regulation and Document Management | |
| Proprietary Name: | Ultracongruent Insert |
| Common Name: | Semi-constrained total knee prostheses |
| Device Classification | Knee joint patellofemorotibial polymer/metal/polymer |
| Name and Reference: | semi-constrained cemented prosthesis per 21CFR 888.3560. |
| This falls under the Orthopedics panel. | |
| Device Class | Class II |
| Panel Code | Orthopaedics Device |
| Device Product Code: | JWH |
| Predicate Device: | 1. "United" U2 Total Knee System (K051640) |
| 2. "United" U2 XPE Total Knee System (K103733) | |
| 3. "Ortho Development" Balanced Knee System (K090705) | |
| 4. "Biomet" Vanguard™ Complete Knee System (K050222) |
Device Description:
The Ultracongruent Insert is designed for the replacement of the bearing and/or articulating surfaces of the proximal tibia composed of an articulating bearing surface fixed in a metal tibial baseplate, and is used for patients with PCL incomplete, absent, nonfunctional or required release. It is used with the cruciate retained (CR) type Femoral Component. The anterior lip of Ultracongruent Insert is more prominent when comparing with the U2 CR Insert (K051640, K103733), which increases the articulating surface area and expands the
1
(9) Ultracongruent Insert
510(k) Summary
circumference to accommodate and stabilize the femur during knee flexion. The Ultracongruent Insert is available in seven proportional sizes (#1~ #7) and five thicknesses (thicknesses of insert + tibial baseplate: 9mm, 11mm, 15mm, and 18mm). The minimum thickness of Ultracongruent Insert is 6 mm on the bearing surface. It is manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834.
Indications:
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 can be satisfactorily balanced and stabilized at the time of surgery. This device system is intended for cemented use only in the U.S.A.
Basis for Substantial Equivalence:
The Ultracongruent Insert has the same indications, size distribution, materials and the same manufacturing and sterilization method as the XPE tibial insert of the "United" U2 Total Knee System. Besides, the basic design, prominent anterior lip height and intended use of the subjected device are similar with the tibial insert of "Ortho Development" Balanced Knee System® (K090705) and "Biomet" Vanguard"" Complete Knee System (K050222).
Performance Data:
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.
2
( Ultracongruent Insert
510(k) Summary
- Constraint Test a.
- Contact Area and Contact Pressure b.
- Range of Motion c.
- d. Interlocking Strength Test
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2014
United Orthopedic Corporation Ms. Fang-Yuan Ho Regulatory Affairs Manager No. 57, Park Avenue 2, Science Park Hsinchu, 300 TAIWAN
Re: K132752
Trade/Device Name: Ultracongruent 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: January 28, 2014 Received: January 29, 2014
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
4
Page 2 - Ms. Fang-Yuan Ho
(21 CFR Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
K132752 510 (k) Number (if known): _
Device Name: Ultracongruent Insert
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 can be satisfactorily balanced and stabilized at the time of surgery. This device system is intended for cemented use only in the U.S.A.
Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Picture/7 description: The image shows the words "Casey L. Hanley, Ph.D." in bold black font. There is a black line underneath the name. Below the line, the words "Division of Orthopedic Devices" are written in bold black font.
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