(73 days)
No
The document describes a physical knee implant and its materials, design, and testing. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The focus is on the mechanical properties and substantial equivalence to predicate devices.
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 due to various types of arthritis and deformities, which directly addresses therapeutic outcomes.
No
Explanation: The device described is a total knee system, specifically a femoral component, used for knee arthroplasty to reduce pain and improve function. It is a prosthetic implant, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a physical femoral component made from Co-Cr-Mo alloy, intended for cemented use in knee arthroplasty. It is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for knee arthroplasty to address pain and improve function in patients with various knee conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a femoral component for a total knee system, made of Co-Cr-Mo alloy, intended for cemented use. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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 intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
This device is an additional size extension to the previously cleared "UNITED" U2 Total Knee System (K051640). The materials; design, safety and effectiveness of this subject is identical to the previously cleared femoral components - PS type of "UNITED" U2 Total Knee System (available in sizes #1~#6 ranging from 52mm/56mm AP-ML to 72mm/ 76mm A/P-M/L), except for its larger size (76mm/80mm A/P-M/L). This device machined from cast Co-Cr-Mo alloy conforming to ASTM F75 are available in left and right configurations. Fixation of the femoral component to the femur is achieved using bone cement. This device is intended to be used with the previously cleared U2 PS tibial insert (K051640), U2 XPE tibial inserts - PS type (K112463), U2 tibial baseplate (K051640), U2 Patella components (K051640, K082469) and U2 XPE Patella components (K112463) in anv size. The size extending of femoral component does not affect the intended use of the device or alter the fundamental scientific technology of the device.
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)
Range of motion analysis, fatigue test, subluxation of femorotibial joint evaluation, contact area and contact pressure analysis on femoropatellar and femorotibial joints and femoral component fatigue fracture evaluation, 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): 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.
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
MAY - 4 2012
(GU2 Femoral Component, PS, #7: Special 510 (K)
510(k) Summary
K12 0507 (1)3
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: | February 17, 2012 |
| Contact Person | Fang-Yuan Ho |
| Regulation and Document Management | |
| Proprietary Name: | U2 Femoral Component, PS, #7 |
| Common Name: | Knee Prosthesis |
| Device Classification | Knee joint patellofemorotibial polymer/metal/polymer |
| Name and Reference: | semi-constrained cemented prosthesis under 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) |
-
"Wright Medical Technology" Advance® Total Knee System (K972626) |
-
" Smith & Nephew" Genesis II Knee System (K951987)
Device Description:
This device is an additional size extension to the previously cleared "UNITED" U2 Total Knee System (K051640). The materials; design, safety and effectiveness of this subject is identical to the previously cleared femoral components - PS type of "UNITED" U2 Total Knee System (available in sizes #1~#6 ranging from 52mm/
1
(U2 Femoral Component, PS, #7: Special 510 (K)
510(k) Summary
56mm AP-ML to 72mm/ 76mm A/P-M/L), except for its larger size (76mm/80mm A/P-M/L). This device machined from cast Co-Cr-Mo alloy conforming to ASTM F75 are available in left and right configurations. Fixation of the femoral component to the femur is achieved using bone cement. This device is intended to be used with the previously cleared U2 PS tibial insert (K051640), U2 XPE tibial inserts - PS type (K112463), U2 tibial baseplate (K051640), U2 Patella components (K051640, K082469) and U2 XPE Patella components (K112463) in anv size. The size extending of femoral component does not affect the intended use of the device or alter the fundamental scientific technology of the device.
Intended 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 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 intended for cemented use only.
Basis for Substantial Equivalence:
The safety and effectiveness of the subject device are substantially equivalent to the previously cleared U2 Total Knee System (K051640), except for an extension in the size distribution. The modifications do not change the intended use or fundamental In addition, the subject device is also substantial equivalence to scientific technology.
2
ம் U2 Femoral Component, PS, #7: Special 510 (K) 510(k) Summary
the PS femoral components of "Wright Medical Technology" Advance® Total Knee System (K972626) and "Smith & Nephew" Genesis II Knee System (K951987).
Performance Data:
Range of motion analysis, fatigue test, subluxation of femorotibial joint evaluation, contact area and contact pressure analysis on femoropatellar and femorotibial joints and femoral component fatigue fracture evaluation, completed as part of the design assurance process, demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.
K120507 (3/3
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
United Orthopedic Corporation % Ms. Fang-Yuan Ho No. 57. Park Avenue 2. Science Park Hsinchu, Taiwan 300
MAY - 4 2012
Re: K120507
Trade/Device Name: U2 Femoral Component, PS, #7 Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained · cemented prothesis Regulatory Class: Class II
Product Code: JWH Dated: April 6, 2012 Received: April 9, 2012
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.
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 (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
4
Page 2 – Ms. Fang-Yuan Ho
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/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 yours.
cerely yours,
For
rk N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
K120507 510 (k) Number (if known):_
Device Name: U2 Femoral Component, PS, #7
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 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 intended for cemented use only
Prescription Use _________x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Adises
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(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number