(24 days)
No
The summary describes a line extension of surgical instrumentation (femoral component trials) for knee replacement, which are physical tools used during surgery. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is a knee replacement system intended for the treatment of painful, disabling joint diseases of the knee, which falls under the definition of a therapeutic device designed to alleviate or cure diseases.
No
The device is described as instrumentation for a knee replacement system, specifically a femoral component trial used to determine the correct alignment, size, and fit of a final prosthesis during total knee arthroplasty. Its purpose is to assist in the surgical procedure for treatment, not to diagnose a disease or condition.
No
The device description explicitly states the additional components are "Instrumentation (Femoral Component Trial)" made of "Stainless steel alloy" and are "reusable device that must be sterilized prior to use," indicating a physical, hardware-based medical device.
Based on the provided information, the EXULT Knee Replacement System, including the additional instrumentation (Femoral Component Trial), is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the system as being for the treatment of painful and disabling joint diseases of the knee, post-traumatic loss of function, and correction/revision of previous procedures. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a knee replacement system and associated surgical instrumentation. The femoral component trial is a tool used during surgery to determine the correct size and fit of the implant. This is a surgical aid, not a device used to test samples from the human body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples (blood, tissue, etc.), analysis of biomarkers, or any other activities typically associated with in vitro diagnostics.
In summary, the EXULT Knee Replacement System is a surgical implant and associated instrumentation used for the treatment of knee conditions, not for diagnosing them.
N/A
Intended Use / Indications for Use
EXULT Knee Replacement System is intended for the treatment of diseases as follows:
· Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;
· Post-traumatic loss of knee joint configuration and function;
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
· Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
EXULT Knee Replacement System is intended for cemented application only.
Product codes
JWH, OOG
Device Description
The Additional components being added to the EXULT Knee Replacement System are:
- Instrumentation (Femoral Component Trial) - The subject EXULT Knee Replacement System components specification inclusions are a line extension of Instrumentation (Femoral Component trial). The following is the additional components.
A) Instrumentation (Femoral Component Trial)
A copy of a final femur prosthesis designed to be used during total knee arthroplasty to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set of trial knee prostheses that match the different anatomical structures of the knee joint, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material. This instrument is a reusable device that must be sterilized prior to use.
Additional Femoral Component Trials are designed based on Femoral Component Trials of predicate device cleared EXULT Knee Replacement System Instrumentation under K200395. This femoral component trials are made of Stainless steel alloy conforming to ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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
Non-Clinical Testing
The following non-clinical laboratory testing and/or engineering analysis were performed to determine substantial equivalence:
- Dimensions measurement testing
- . Assembly testing
The dimensions of additional instruments (Femoral component trials) are exactly same with predicate devices under K200395 and additional performance testing is unnecessary since the trial is not implanted.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
July 30, 2020
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.
Corentec Co., Ltd Sungwon Yang Director, QA & RA 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungchongnam-do 31056 SOUTH KOREA
Re: K201851
Trade/Device Name: EXULT Knee Replacement System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH. OOG Dated: June 29, 2020 Received: July 6, 2020
Dear Sungwon Yang:
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, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201851
Device Name
EXULT Knee Replacement System
Indications for Use (Describe)
EXULT Knee Replacement System is intended for the treatment of diseases as follows:
· Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;
· Post-traumatic loss of knee joint configuration and function;
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
· Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
EXULT Knee Replacement System is intended for cemented application only.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
Corentec Co.,Ltd. EXULT Knee Replacement System - Specification Inclusion June 29, 2020
ADMINISTRATIVE INFORMATION
| Manufacturer: | Corentec Co., Ltd.
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu
Cheonan-si, Chungchongnam-do, South Korea -31056
Telephone: +82-41-585-7114; Fax: +82-41-585-7113 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Sungwon Yang
Director – QA&RA
12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu
Cheonan-si, Chungchongnam-do, South Korea -31056
Ph: +82-41-410-7176 (Direct) ; Fax: +82-41-585-7113
Email: sungwon.yang@corentec.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | EXULT Knee Replacement System |
|---|---|
| Common Name: | Total Knee Joint Replacement Prosthesis |
| Classification Regulations: | 21 CFR 888.3560 |
| Class: | II |
| Product Codes: | JWH, OOG |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
INTENDED USE
EXULT Knee Replacement System is intended for the treatment of diseases as follows:
- Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;
- Post-traumatic loss of knee joint configuration and function; ●
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures . can be returned to adequate function and stability;
- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
4
The EXULT Knee Replacement System is intended for cemented application only.
DEVICE DESCRIPTION
The Additional components being added to the EXULT Knee Replacement System are:
- Instrumentation (Femoral Component Trial) -
The subject EXULT Knee Replacement System components specification inclusions are a line extension of Instrumentation (Femoral Component trial). The following is the additional components.
A) Instrumentation (Femoral Component Trial)
A copy of a final femur prosthesis designed to be used during total knee arthroplasty to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set of trial knee prostheses that match the different anatomical structures of the knee joint, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material. This instrument is a reusable device that must be sterilized prior to use.
Additional Femoral Component Trials are designed based on Femoral Component Trials of predicate device cleared EXULT Knee Replacement System Instrumentation under K200395. This femoral component trials are made of Stainless steel alloy conforming to ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments.
SUBSTANTIAL EQUIVALENCE
EXULT Knee Replacement System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Substantially equivalent products for EXULT Knee Replacement System are as follows,
| Device | Manufacturer | Trade or Proprietary
or Model Name | 510(k) |
|----------------------|-------------------|-------------------------------------------------------|---------|
| Primary
Predicate | Corentec Co. Ltd. | EXULT Knee
Replacement System
(Instrumentation) | K200395 |
Summary of Technological Characteristics:
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EXULT Knee Replacement System additional instrumentation performed either similar comparable predicate devices and is as safe and effective as predicate device. Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. At a high level, the EXULT Knee Replacement System has the following similarities to the predicate devices:
- has the same intended use, O
- has the same indications for use, O
- uses the same operating principles, O
- incorporates the same basic designs, O
- incorporates the same/similar materials, and o
- o is supplied non-sterile
Non-Clinical Testing
The following non-clinical laboratory testing and/or engineering analysis were performed to determine substantial equivalence:
- Dimensions measurement testing
- . Assembly testing
The dimensions of additional instruments (Femoral component trials) are exactly same with predicate devices under K200395 and additional performance testing is unnecessary since the trial is not implanted.
Clinical Testing
Clinical testing was not required as a basis for substantial equivalence
STERILIZATION & PACKAGING
The EXULT Knee System Instrumentation is supplied non-sterile and cited predicate devices are non-sterile.
CONCLUSION
6
Corentec Co., Ltd. believes that the subject device is substantially equivalent to the legally marketed predicate device based on intended use, technology, material, as well as the mechanical testing and biocompatibility assessment.