(20 days)
No
The document describes a physical knee replacement system and its components, with no mention of software, algorithms, or AI/ML technologies.
Yes
Explanation: The device is a knee replacement system intended for the treatment of painful, disabling joint disease of the knee, traumatic arthritis, or avascular necrosis, all of which aim to alleviate symptoms or restore function, thus qualifying it as therapeutic.
No
This device is a knee replacement system used for the treatment of various knee diseases and conditions. It is a prosthetic implant, not a tool for diagnosing medical conditions.
No
The device description explicitly states it is a "Tibial Insert" and describes its physical characteristics and testing related to wear, constraint, contact pressure, and range of motion, all of which are associated with a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating knee joint diseases and deformities. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a component of a knee replacement system (a tibial insert). This is a physical implant used in surgery.
- 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 performance studies focus on mechanical properties and wear, which are relevant to surgical implants, not diagnostic tests.
Therefore, the EXULT Knee Replacement System, including the described tibial insert, falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
EXULT Knee Replacement System is indicated 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
Device Description
The purpose of the submission is a line extension of the EXULT Tibial Insert (UC-type) to the EXULT Knee Replacement System (K192507). The UC-type Tibial Inserts are designed based on the design of the other Tibial Inserts of the EXULT Knee Replacement System (PS-type and CR-type). The UC-type, which is ultra-congruent, has high conformity and increased anterior/posterior edge height, which limits anterior/posterior motion instead of a post structure, like the PS-type. The UC-type Tibial Insert matches Femoral Components of one-size up and down. The UC-type Tibial Insert is symmetrical and used in both the right and left knee. It is only used in combination with the Femoral component/Tibial baseplate of the predicate device (K192507).
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:
- Wear Testing as per ISO 14242-1&2, ASTM F2003-02
- Constraint test as per ASTM F1223
- Contact pressure as per ASTM F2083, ASTM F1672
- Range of Motion as per ISO 21536
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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August 1, 2024
Corentec Co., Ltd. Seo Sanghee Senior Manager 33-2, Banpo-daero 20-gil, Seocho Gu, Seoul, 06649 Republic of Korea
Re: K242046
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 Dated: July 12, 2024 Received: July 12, 2024
Dear Seo Sanghee:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Lixin Liu-S" in a simple, sans-serif font. The text is black against a light background. The letters are evenly spaced and clearly legible. The overall impression is clean and professional.
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
EXULT Knee Replacement System
Indications for Use (Describe)
EXULT Knee Replacement System is indicated 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
ADMINISTRATIVE INFORMATION
Manufacturer: Corentec Co., Ltd. 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu, Cheonansi, Chungchongnam-do, Republic of Korea (31056) Telephone: +82-41-585-7114 Fax: +82-41-585-7113 Official Contact: Sanghee Seo RA Senior Manager 33-2, Banpo-daero 20-gil, Seocho-gu, Seoul, Republic of Korea (06649) Tel: +82-2-6937-4902 Fax: +82-2-3445-5497 E-mail: sh.seo@corentec.com Date Prepared: July 12, 2024
DEVICE NAME AND GENERAL INFORMATION
| Trade/Proprietary Name: | EXULT Knee Replacement System |
|---|---|
| Common Name: | Total Knee Joint Replacement |
| Classification | 21 CFR 888.3560 |
| Regulations: Regulatory | Class II |
| Class: Product Codes: | JWH |
| Classification Panel: | Orthopedic Products Panel |
Predicate device
Primary predicate device: EXULT Knee Replacement System, Corentec Co., Ltd. (K192507).
Reference device: LOSPA Total Knee System, Corentec Co., Ltd. (K110404, K121037, K130673)
Device Description
The purpose of the submission is a line extension of the EXULT Tibial Insert (UC-type) to the EXULT Knee Replacement System (K192507). The UC-type Tibial Inserts are designed based on the design of the other Tibial Inserts of the EXULT Knee Replacement System (PS-type and CR-type). The UC-type, which is ultra-congruent, has high conformity and increased anterior/posterior edge height, which limits anterior/posterior motion instead of a post structure, like the PS-type. The UC-type Tibial Insert matches Femoral Components of one-size up and down. The UC-type Tibial Insert is symmetrical and used in both the right and left knee. It is only used in combination with the Femoral component/Tibial baseplate of the predicate device (K192507).
5
Indications for Use
EXULT Knee Replacement System is indicated 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.
Summary of Technological Characteristics
Device Comparisons and performance testing indicate that EXULT Tibial Insert (UC-type) of the EXULT Knee Replacement System is substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles. It offers an additional option of constraint to the existing Tibial Inserts available with the EXULT Knee Replacement System.
Non-Clinical Testing
The Corentec Co., Ltd. has evaluated the subject EXULT Tibial Insert (UC-type) to demonstrate substantial equivalence to the predicate devices.
- . Wear Testing as per ISO 14242-1&2, ASTM F2003-02
- Constraint test as per ASTM F1223 ·
- . Contact pressure as per ASTM F2083, ASTM F1672
- . Range of Motion as per ISO 21536
Substantial Equivalence Conclusion
Based on above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.