(110 days)
No
The summary describes a traditional knee implant system and does not mention any AI/ML components or capabilities.
No
The device is a knee replacement system used to treat severe knee pain and disability, which is a restorative or reconstructive function, not typically classified as therapeutic in the context of directly treating disease through intervention like medication, radiation, or specific therapies.
No
The device description indicates that the OptiGen™ Total Knee System is a replacement knee joint system, consisting of components like femoral and tibial components, rather than equipment designed to diagnose medical conditions.
No
The device description clearly states it consists of physical components like femoral, tibial, and patellar components, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the OptiGen™ Total Knee System is a surgical implant used to replace a damaged knee joint in patients with specific conditions like arthritis and deformities. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a knee replacement system (femoral, tibial, patellar components, etc.) made from materials suitable for implantation. This aligns with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device is directly implanted into the patient.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. The OptiGen™ Total Knee System is an in vivo (inside the body) surgical implant.
N/A
Intended Use / Indications for Use
The OptiGenTM Total Knee System is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis
- Failed osteotomies, unicompartmental replacement, or total knee replacement
- Moderate varus, valgus, or flexion deformities
This device is indicated for cemented use only.
Product codes
JWH
Device Description
OptiGenTM Total Knee System consists of femoral components(PS, CR), tibial components, tibial bearings(PS, CR), patellar components and accessories(locking bars, tibial cement plug). Components are available in a variety of designs and size ranges intended for primary application with bone cement. Implant components are made from materials meeting the requirements of various widely recognized standards including ISO, ASTM.
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
Not Found
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)
The OptiGenTM Total Knee System was tested in a non clinical setting (bench testing) to assess that no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the OptiGenTM Total Knee System is substantially equivalent to the predicate devices.
The following tests were performed:
(1) Static test
- A/P shear test
- M/L shear test
- Tensile pull-off test
- Locking bar removal test
- A/P draw test
- M/L draw test
- I/E roration test
- Patellofemoral subluxation test
- Tibial tray test
- Post shear test
- Femorotibial contact test
- Patellofemoral contact test
(2) Dynamic test - Tibial tray test
- Post shear 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.
Genesis II Total Knee System - K951987, Maxim Knee System - K915132, K922285, K993159, P.F.C Sigma Knee System - K884796, K892394, K935262, NexGen CR-Flex, LPS-Flex System - K933785, K023211, U2 Total Knee System - K021657, MG II Porous Total Knee System - K892800
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
K102367
pg 1 of 3
DEC - 8 2010
| Manufacturer: | U & I Corporation
529-1, Yonghyun-dong, Uijungbu
Kyunggi-Do, Korea 480-050
Gyeong-Je Kwon, Regulatory Affairs Specialist |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation
529-1, Yonghyun-dong, Uijungbu
Kyunggi-Do, Korea 480-050 |
| Sponsor Contact: | Gyeong-Je Kwon, Regulatory Affairs Specialist |
| Date Prepared: | August 19, 2010 |
| Trade Name: | OptiGenTM Total Knee System |
| Common Name: | Total Knee System |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis, per 21 CFR 888.3560 |
| Product Code: | JWH |
| Predicate Devices: | Genesis II Total Knee System - K951987
Maxim Knee System - K915132, K922285, K993159
P.F.C Sigma Knee System - K884796, K892394, K935262
NexGen CR-Flex, LPS-Flex System - K933785, K023211
U2 Total Knee System - K021657
MG II Porous Total Knee System - K892800 |
Description of Device:
- 510(k) Summary
OptiGen™ Total Knee System consists of femoral components(PS, CR), tibial components, tibial bearings(PS, CR), patellar components and accessories(locking bars, tibial cement plug). Components are available in a variety of designs and size ranges intended for primary application with bone cement. Implant components are made from materials meeting the requirements of various widely recognized standards including ISO, ASTM.
OptiGen™ Total Knee System
Image /page/0/Picture/8 description: The image shows the logo for U & I Corporation. The logo is in black and white. The letters U and I are large and bolded, with the ampersand (&) in between them. The word "CORPORATION" is to the right of the letters, in a smaller, bolded font.
1
K102367
pg 2 of 3
Materials
Femoral components Tibial Components Tibial Bearings Patellar Components Tibial Cement Plug Locking Bars
CoCrMo Alloy (ASTM F75) Titanium Alloy (ASTM F136) UHMWPE (ASTM F648) UHMWPE (ASTM F648) UHMWPE (ASTM F648) Titanium Alloy (ASTM F136)
Intended Use:
The OptiGen™ Total Knee System is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis ●
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis ●
- Failed osteotomies, unicompartmental replacement, or total knee ● replacement
- Moderate varus, valgus, or flexion deformities .
This device is indicated for cemented use only.
Substantial Equivalence:
The OptiGen™ Total Knee System is substantially equivalent to Genesis II Total Knee System(K951987), Maxim Knee System(K915132, K922285, K993159), P.F.C Sigma Knee System(K884796, K892394, K935262), NexGen CR-Flex, LPS-Flex System(K933785, K023211), U2(K021657), MG II(K892800) in design, performance, function and intended use.
-
- Comparison technological characteristics
The Predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities:
- Comparison technological characteristics
-
The similar indications for use
-
Similar design features .
-
Incorporate the same or similar materials .
-
The equivalent mechanical performance ●
Image /page/1/Picture/19 description: The image shows the logo for U&I Corporation. The logo features a stylized "U&I" in bold, black font. To the right of the letters is the word "CORPORATION" in a smaller, sans-serif font, also in black.
OptiGen™ Total Knee System
2
K102367
pg 30ff3
- Performance Testing
The OptiGen™ Total Knee System was tested in a non clinical setting (bench testing) to assess that no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the OptiGen™ Total Knee System is substantially equivalent to the predicate devices.
The following tests were performed: (1) Static test
- A/P shear test ●
- M/L shear test .
- Tensile pull-off test .
- Locking bar removal test .
- A/P draw test .
- M/L draw test .
- I/E roration test ●
- Patellofemoral subluxation test .
- Tibial tray test .
- Post shear test .
- Femorotibial contact test
- Patellofemoral contact test
- (2) Dynamic test
- Tibial tray test .
- Post shear test .
3. Conclusion
The data and information provided in this submission support the conclusion that the OptiGen™ Total Knee System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.
U&J CORPORATION
OptiGen™ Total Knee System
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
U&I Corporation % Mr. Gyeong-Je Kwon Assistant Manager, Regulatory Affairs 529-1, Yonghyun-dong, Uijungbu Kyunggi-Do, Korea 480-050
DEC - 8 2010
Re: K102367
Trade/Device Name: OptiGen™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 19, 2010 Received: November 22, 2010
Dear Mr. Kwon:
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 - Mr. Gyeong-Je Kwon
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.lda.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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark H. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
DEC - 8 2010
510(k) Number (if known): __ K102367
Device Name: OptiGen™ Total Knee System
Indications for Use:
The OptiGen™ Total Knee System is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis ●
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis .
- Failed osteotomies, unicompartmental replacement, or total knee . replacement
- Moderate varus, valgus, or flexion deformities ●
This device is indicated for cemented use only.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Mettesson
Division Sign-Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102367
U&i CORPORATION
OptiGen™ Knee System