(28 days)
No
The document describes surgical instruments for total knee arthroplasty and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The changes described are related to the physical design of the instruments based on user feedback.
No.
The device described is composed of surgical instruments used during total knee arthroplasty procedures, not the therapeutic implant itself.
No
The device description states that the product consists of surgical instruments intended to facilitate total knee arthroplasty procedures, which are used during surgery rather than for diagnosis.
No
The device description explicitly states the subject devices are "surgical instruments" and describes physical components like "implant specific trials," "guide, alignment instruments," "cutting guides," "AP sizer external rotation instrument," and "cutting block instruments." These are all hardware components used in surgery.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used in total knee arthroplasty surgery for treating painful and disabling joint diseases of the knee. This is a surgical procedure performed on the patient's body, not a test performed on samples taken from the body.
- Device Description: The device is described as surgical instruments for knee joint replacement procedures. These are tools used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such testing.
Therefore, the LOSPA TKR System and EXULT Knee System instruments are surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
LOSPA TKR System is intended for use in total knee arthroplasty surgery for the following indications:
· 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.
LOSPA TKR System is intended for cemented application only.
EXULT Knee 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 System is intended for cemented application only.
Corentec knee instruments are accessory devices and are intended to be used to assist in the implantation of LOSPA Knee Systems (Primary, Modular), EXULT Knee Replacement System in their cleared Indications for Use as provided below:
LOSPA Knee System, EXULT Knee Replacement System are 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.
The LOSPA, EXULT Knee Replacement System are intended for cemented application only.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH, OOG
Device Description
The subject devices in this special 510(k) are the surgical instruments for the LOSPA Modular Knee System and EXULT Knee System, and submitted as a line extension of optional instruments for Corentec's FDA-cleared reusable orthopedic knee joint replacement instruments. The subject instruments are part of Corenter' 510(k)-cleared knee product lines and are required to facilitate total knee arthroplasty procedures.
LOSPA Modular Knee System Instruments
Implant specific trials - the design of the connection part of the trials to the instrument has been revised due to customer's needs.
Guide, alignment instruments - the design of the cutting guides and alignments instruments have been revised due to customer's needs.
EXULT Knee System Instruments
AP sizer external rotation instrument and cutting block instruments have been developed to facilitate to check in posterior access during the operation based on US surgeon's request.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Dimensions measurement testing
- Assembly testing
No clinical or animal testing were required.
Key Results: The subject instruments performed comparable to predicate devices and are as safe and effective as the predicate devices. Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. The subject instruments have the following similarities to the predicate devices:
- Have the same intended use, .
- Have the same indications for use,
- . Use the same operating principles,
- Incorporate the same basic designs,
- Incorporate the same/similar materials, and ・
- . Are supplied non-sterile.
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.
K192507, K110404, K130673, K200395, K201851, K212034
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
August 26, 2022
Corentec Co., Ltd. Yoorim Bae RA Manager 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu Cheonan-si, Chungcheongnam-do 31056 Republic of Korea
Re: K22278
Trade/Device Name: LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH, OOG Dated: June 27, 2022 Received: July 29, 2022
Dear Yoorim Bae:
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.
1
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 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 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).
Sincerely.
For Ting Song, Ph.D., R.A.C. 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
2
Indications for Use
510(k) Number (if known)
K222278
Device Name
LOSPA TKR System Instrumentation
Indications for Use (Describe)
LOSPA TKR System is intended for use in total knee arthroplasty surgery for the following indications:
· 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.
LOSPA TKR 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K222278
Device Name
EXULT TKR System Instrumentation
Indications for Use (Describe)
EXULT Knee 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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for LOSPA, EXULT Knee Instruments changes.
Date: June 27, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer: | Corentec Co., Ltd. |
|---|---|
| 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu | |
| Cheonan-si, Chungcheongnam-do, Rep. of Korea -31056 | |
| Telephone: +82-41-585-7114; Fax: +82-41-585-7113 | |
| Official Contact: | Yoorim Bae |
| RA Manager | |
| 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-Gu | |
| Cheonan-si, Chungcheongnam-do, Rep. of Korea -31056 | |
| Ph: +82-41-410-7116 (Direct) ; Fax: +82-41-585-7113 | |
| Email: yoorim.bae@corentec.com | |
| Trade or Proprietary Name: | LOSPA TKR System Instrumentation, |
| EXULT TKR System Instrumentation | |
| Common Name: | Orthopedic Surgical Instruments |
| Regulatory Class: | Class II |
| Regulation Number: | 21CFR888.3560 |
| Regulation Name: | Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi- |
| Constrained Cemented Prosthesis | |
| Product Code(s): | JWH, MBH, OOG |
Legally Marketed Device(s) to Which Equivalence is Claimed
| 510(k) Number | Trade Name | Submitter | Product Code | |
|---|---|---|---|---|
| Primary | K160157 | LOSPA Modular Knee System | JWH, MBH | |
| Reference | K192507 | LOSPA II Knee System | JWH | |
| K110404 | LOSPA Total Knee System | |||
| (EAUM Total Knee System) | JWH | |||
| K130673 | LOSPA Total Knee Replacement System | Corentec Co.,Ltd | JWH | |
| K200395 | EXULT Knee Replacement System | JWH | ||
| K201851 | EXULT Knee Replacement System | JWH, OOG | ||
| K212034 | LOSPA TKR System | JWH, MBH |
Reason for 510(k) Submission
The purpose of this submission is to include additional instruments for LOSPA Modular Knee System and EXULT Knee System.
5
DEVICE INFORMATION
A. Device Description
The subject devices in this special 510(k) are the surgical instruments for the LOSPA Modular Knee System and EXULT Knee System, and submitted as a line extension of optional instruments for Corentec's FDA-cleared reusable orthopedic knee joint replacement instruments. The subject instruments are part of Corenter' 510(k)-cleared knee product lines and are required to facilitate total knee arthroplasty procedures.
LOSPA Modular Knee System Instruments
Implant specific trials - the design of the connection part of the trials to the instrument has been revised due to customer's needs.
Guide, alignment instruments - the design of the cutting guides and alignments instruments have been revised due to customer's needs.
EXULT Knee System Instruments
AP sizer external rotation instrument and cutting block instruments have been developed to facilitate to check in posterior access during the operation based on US surgeon's request.
B. Intended Use
Corentec knee instruments are accessory devices and are intended to be used to assist in the implantation of LOSPA Knee Systems (Primary, Modular), EXULT Knee Replacement System in their cleared Indications for Use as provided below:
LOSPA Knee System, EXULT Knee Replacement System are 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.
The LOSPA, EXULT Knee Replacement System are intended for cemented application only.
C. Summary of Technological Characteristics
The subject instruments performed comparable to predicate devices and are as safe and effective as the predicate devices. Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy. The subject instruments have the following similarities to the predicate devices:
- Have the same intended use, .
- Have the same indications for use,
- . Use the same operating principles,
6
- Incorporate the same basic designs, ·
- Incorporate the same/similar materials, and ・
- . Are supplied non-sterile.
D. Non-Clinical Testing
The following non-clinical laboratory testing and/or engineering analysis were performed to determine substantial equivalence:
- ・ Dimensions measurement testing
- . Assembly testing
E. Clinical and Animal Testing
No clinical or animal testing were required.
F. Substantial Equivalence Conclusion
Based on the similarities to the predicate devices and rationale to support substantial equivalence, the subject devices are substantially equivalent to the commercially available predicate devices.