(163 days)
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 of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
LOSPA TRK System is intended for cemented application only.
The Additional components being added to the LOSPA TKR System are:
Instrumentation (Tibial Insert Trial) -
The subject LOSPA TKR System components specification inclusions are a line extension of Instrumentation (Tibial Insert trial). The following is the additional components.
A) Instrumentation (Tibial Insert Trial)
A copy of a final tibial 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 femoral component trial prosthesis and a tibial baseplate trial prosthesis. This instrument is a reusable device that must be sterilized prior to use.
Additional Tibial Insert Trials are designed based on Tibial Insert Trials of predicate device cleared LOSPA TKR System Instrumentation under K110404 & K130673 & K160157 & K192507 & K200395. There is one eliminated size, 26T of each design (CR and PS), each for left and right sides. For both CR and PS designs, the ranges of dimensions are the same. The components have slightly modified height. Except for the differences of height, lengths are identical to the previously cleared Tibial insert trials. The subject LOSPA TKR System is available in nine proportional sizes.
This Tibial Insert Trials are made of Propylux conforming to ASTM D4101: Standard Classification System and Basic for Specification for Polypropylene Injection and Extrusion Materials.
The provided text describes a 510(k) premarket notification for the LOSPA TKR System, specifically focusing on the inclusion of new instrumentation (Tibial Insert Trial). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader improvement.
The document is a regulatory submission for a medical device (knee joint prosthesis instrumentation) and details:
- Device Name: LOSPA TKR System
- Manufacturer: Corentec Co., Ltd.
- Regulatory Classification: Class II, Product Codes JWH, MBH
- Indications for Use: Total knee arthroplasty for specific conditions (osteoarthritis, rheumatoid arthritis, post-traumatic loss of function, moderate varus/valgus/flexion deformity, revision of unsuccessful procedures). Intended for cemented application only.
- Device Description: The submission is for additional instrumentation (Tibial Insert Trial) for the existing LOSPA TKR System. These trials are sized for correct alignment, size, and fit of the final prosthesis, are reusable, and made of Propylux.
- Substantial Equivalence: The device is being submitted as substantially equivalent to previously cleared LOSPA Total Knee System products (K110404, K130673, K160157, K192507, K200395).
The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is typically associated with studies proving the clinical or analytical performance of diagnostic or AI-enabled devices. This document pertains to the modification of an existing mechanical prosthetic system, specifically the inclusion of new instrumentation (a trial component), not a diagnostic algorithm or a device requiring such performance studies.
Therefore, I cannot extract the requested information from the provided text because it does not contain data on:
- Acceptance criteria and reported device performance: No specific performance metrics (e.g., sensitivity, accuracy) are mentioned for the Tibial Insert Trial.
- Sample size, data provenance: Not applicable for this type of submission which is for mechanical instrumentation.
- Number/qualifications of experts, adjudication method: Not relevant for this type of device.
- MRMC study: Not relevant.
- Standalone performance: Not relevant.
- Type of ground truth: Not relevant.
- Training set sample size/ground truth establishment: Not relevant, as this is not an AI/algorithmic device.
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December 9, 2021
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Corentec Co., Ltd. Sungwon Yang QMR 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk Gu Cheonan-si, Chungchongnam-do 31056 SOUTH KOREA
Re: K212034
Trade/Device Name: LOSPA TKR System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: November 3, 2021 Received: November 3, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
Ting Song -S
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212034
Device Name LOSPA TKR System
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 of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
LOSPA TRK 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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Special 510(k): Specification Inclusion
LOSPA TKR System
510(K) SUMMARY
Corentec Co.,Ltd. LOSPA TKR System - Specification Inclusion of its instrumentation June 23th, 2021
ADMINISTRATIVE INFORMATION
| Manufacturer: | Corentec Co., Ltd. |
|---|---|
| 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-GuCheonan-si, Chungchongnam-do, South Korea -31056 | |
| Telephone: +82-41-585-7114; Fax: +82-41-585-7113 | |
| Official Contact: | Seungri KimAssociate – RA |
| 12, Yeongsanhong 1-gil, Ipjang-Myeon, Seobuk-GuCheonan-si, Chungchongnam-do, Rep. of Korea -31056 | |
| Ph: +82-41-410-7117 (Direct) ; Fax: +82-41-585-7113 | |
| Email: sr.kim@corentec.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | LOSPA TKR System |
|---|---|
| Common Name: | Total Knee Joint Replacement Prosthesis |
| Classification Regulations: | 21 CFR 888.3560 |
| Class: | II |
| Product Codes: | JWH, MBH |
| Classification Panel: | Orthopedic Products Panel |
| Reviewing Branch: | Orthopedic Devices Branch |
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Special 510(k): Specification Inclusion
LOSPA TKR System
INTENDED USE
The intended use of the added specification has not changed as a result of the modification of the predicate device cleared under LOSPA Total Knee System, K110404 & K130673 & K160157 & K192507 & K200395.
The LOSPA Total Knee Replacement 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.
The LOSPA Total Knee Replacement System is intended for cemented use only.
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Special 510(k): Specification Inclusion
LOSPA TKR System
DEVICE DESCRIPTION
The Additional components being added to the LOSPA TKR System are:
Instrumentation (Tibial Insert Trial) -
The subject LOSPA TKR System components specification inclusions are a line extension of Instrumentation (Tibial Insert trial). The following is the additional components.
A) Instrumentation (Tibial Insert Trial)
A copy of a final tibial 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 femoral component trial prosthesis and a tibial baseplate trial prosthesis. This instrument is a reusable device that must be sterilized prior to use.
Additional Tibial Insert Trials are designed based on Tibial Insert Trials of predicate device cleared LOSPA TKR System Instrumentation under K110404 & K130673 & K160157 & K192507 & K200395. There is one eliminated size, 26T of each design (CR and PS), each for left and right sides. For both CR and PS designs, the ranges of dimensions are the same. The components have slightly modified height. Except for the differences of height, lengths are identical to the previously cleared Tibial insert trials. The subject LOSPA TKR System is available in nine proportional sizes.
This Tibial Insert Trials are made of Propylux conforming to ASTM D4101: Standard Classification System and Basic for Specification for Polypropylene Injection and Extrusion Materials.
SUBSTANTIAL EQUIVALENCE
LOSPA TKR 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 LOSPA TKR System are as follows,
§ 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.