(30 days)
No
The summary describes a physical implant (patellar component) and its intended use and design. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies focus on mechanical testing of the implant.
Yes
The Intended Use section states that the device is indicated for "reduction or relief of pain and/or improved knee function," which are therapeutic outcomes.
No
This device is a medical implant (patellar component for knee arthroplasty), not a diagnostic tool. Its purpose is to replace or improve a damaged knee joint, not to identify or characterize a disease or condition.
No
The device description clearly states it is a physical patellar component made from UHMWPE bar with a three-pegged design for fixation, indicating it is a hardware device.
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 patellar component for knee arthroplasty. This is an implantable device used in surgery to replace a damaged part of the knee joint.
- Intended Use: The intended use clearly states it's for the reduction or relief of pain and/or improved knee function in patients with various knee conditions, and it's indicated for cemented use only during surgery. This is a therapeutic and structural function, not a diagnostic one performed on a sample.
The device is a surgical implant, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The U2 Patella 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 indicated for cemented use only.
Product codes
JWH
Device Description
The subject "UNITED" U2 Patella is identical to the legal on-market patellar components in the U2 Total Knee System (available in sizes 26, 29, 32, 35, and 38 mm), except for its larger diameter (available in sizes 41 and 44 mm). The patellar component is machined from extruded UHMWPE bar. It has a three-pegged design for fixation to the host patella and cement groove designed for cemented use only. The radius of dome for the patella components in U2 Patella and U2 Total Knee System are both 23.8 mm. The diameter and length of the pegs of these two systems are 5.0 mm and 4.5 mm, respectively.
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)
Performance testing, including patellofemoral contact area and lateral stability testing of the U2 Patella, completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
g U2 Patella: Additional Size
510(k) Summary
510(k) Summary of Safety and Effectiveness
Submission Information
| Company: | United Orthopedic Corporation | |
|---|---|---|
| Address: | No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan | |
| Contact Person: | Rudy Chen, | |
| Regulatory Affairs | ||
| Phone:+886-3-5773351 ext. 331 | ||
| Fax:+886-3-5670452 | ||
| Date Prepared: | August 25, 2008 |
Device Identification
| Device Name: | U2 Patella |
|---|---|
| Common Name: | Semi-constrained total knee prostheses |
| Classification Name | |
| and Reference : | Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis per 21CFR 888.3560. | |
| This falls under the Orthopedics panel. | |
| Predicate Device: | "UNITED" U2 Total Knee system, manufactured by United |
| Orthopedic Corporation, K051640, cleared March 01, 2006 |
Intended Use
The U2 Patella 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
UOC-FDA-010
Page: Summary-1/2
1
മ്മ U2 Patella: Additional Size
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 indicated for cemented use only.
Device Description:
The subject "UNITED" U2 Patella is identical to the legal on-market patellar components in the U2 Total Knee System (available in sizes 26, 29, 32, 35, and 38 mm), except for its larger diameter (available in sizes 41 and 44 mm). The patellar component is machined from extruded UHMWPE bar. It has a three-pegged design for fixation to the host patella and cement groove designed for cemented use only. The radius of dome for the patella components in U2 Patella and U2 Total Knee System are both 23.8 mm. The diameter and length of the pegs of these two systems are 5.0 mm and 4.5 mm, respectively.
Statement of Technological Comparison
The materials for the subject and predicate devices are identical. The design of the subject and predicate device is the same, except that the subject device has larger size: 41 and 44 mm diameter. The performance testing is sufficient to demonstrate that the subject and predicate devices are substantially equivalent with regard to design. The modification does not change the intended use or fundamental scientific technology.
Performance Data:
Performance testing, including patellofemoral contact area and lateral stability testing of the U2 Patella, completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.
Public Health Service
SEP 2 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
United Orthopedic Corporation % Mr. Rudy Chen Regulatory Affairs, Manager No. 57, Park Avenue 2, Science Park, Hsinchu 300, Taiwan
Re: K082469 Trade/Device Name: U2 Patella Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Codes: JWH Dated: August 25, 2008 Received: August 27, 2008
Dear Mr. Chen:
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, 7 rug 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2 - Mr. Rudy Chen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
082469
510 (k) Number (if known):
Device Name: _U2 Patella
Indications for Use:
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 erosion, dysfunction or prior patcllectorny, 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 designed for cemented use only.
| Prescription Use | x |
|---|---|
| AND/OR |
ver-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Occurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off Division of General, Restorative. and Neurological Devi
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510(k) Number