(94 days)
Not Found
No
The device description focuses on the mechanical components and design of a knee prosthesis. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML technology in medical devices.
Yes
The device is a knee prosthesis, which is implanted to reduce pain and improve function in patients with severe knee conditions, clearly serving a therapeutic purpose.
No
This device is a total knee arthroplasty system intended for pain relief and improved knee function, not for diagnosing medical conditions.
No
The device description clearly states that the ASK System is a physical knee prosthesis consisting of multiple hardware components (femoral component, tibial insert, tibial tray, and patellar component).
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 knee arthroplasty to address pain and improve function in patients with severe knee issues. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical prosthesis (femoral component, tibial insert, tibial tray, and patellar component) designed to be implanted in the knee joint. This is a medical device, but not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's condition based on in vitro testing.
In summary, the ASK System is a surgical implant used for treatment, not a device used to perform diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The ASK System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The ASK System is designed for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The ASK System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a patellofemorotibial, polymer/metal/ polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray, and patellar component.
The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component.
The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
skeletally mature patients
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 ASK System was tested for fatigue performance of the tibial tray, interlock mechanism strength (between the tibial tray and tibial insert), shear fatigue strength of the tibial insert post, contact pressures and areas, lateral subluxation of patellar component, knee constraint tests, jump distance test and range of motion performance. Test results indicate that the ASK System performs as well as the predicate Acculoc Total Knee System and is capable of withstanding expected in vivo loading without failure. Biocompatibility risk assessment and pyrogenicity testing has also been conducted.
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.
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
Image /page/0/Picture/0 description: The image contains 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.
L and K BIOMED Corporation Limited Semi Jang RA Deputy Manager 18f, 159-1, Mokdongseo-ro Yangcheon-gu, Seoul, 07997 Korea
Re: K181146
Trade/Device Name: The ASK 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: April 30, 2018 Received: May 1, 2018
Dear Semi Jang:
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 avare 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.
August 3, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known) K181146
Device Name The ASK System
Indications for Use (Describe)
The ASK System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The ASK System is designed for cemented use 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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3
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a): 1.
| Submitter: | L&K BIOMED Co., Ltd.
18f, 159-1, Mokdongseo-ro, Yangcheon-gu, Seoul,
07997, Korea
Phone. 82-2-6717-1985
e-mail: smjang@lnkbiomed.com |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Semi Jang |
| Date prepared: | March 30, 2018 |
2. Device Identification
| Trade Name | The ASK System |
|---|---|
| Common Name | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, |
| SEMI-CONSTRAINED, CEMENTED, | |
| POLYMER/METAL/POLYMER | |
| Product Code | JWH |
| Regulatory Class | 2 |
| Classification Name | Knee joint patellofemorotibial polymer/metal/polymer |
| semi-constrained cemented prosthesis per 21CFR | |
| 888.3560. This falls under the Orthopedics panel/87 | |
| as a ClassII device. |
3. Purpose of 510(k)
The L&K BIOMED Co., Ltd. here by submits this traditional 510(k)
-
- Predicate or legally marketed devices which are substantially equivalent:
Acculoc Total Knee System (K170753)
- Predicate or legally marketed devices which are substantially equivalent:
Description of the Device 5.
The ASK System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a patellofemorotibial, polymer/metal/ polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray, and patellar component.
The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component.
4
The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
| Product | Material | Standard |
|---|---|---|
| Femoral component | CoCrMo Alloy | ASTM F75 |
| Tibial Tray | Ti-6Al-4V ELI | ASTM F136 |
| Tibial Insert | UHMWPE (GUR 1050) | ASTM F648 |
| Patella | UHMWPE (GUR 1050) | ASTM F648 |
Materials:
6. Indication for Use
The ASK System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, avascular necrosis of the femoral condyle, posttraumatic loss of joint configuration. Moderate valgus, varus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. This device may also be indicated in correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure. The ASK System is designed for cemented use only.
Comparison of the technological characteristics of the subject and predicate 7. devices
The ASK System is substantially equivalent to legally marketed device as the Acculoc Total Knee System (K170753). They are similar in design, materials, scientific technologies, intended use, indications and manufacturing process.
Performance Testing 8.
The ASK System was tested for fatigue performance of the tibial tray, interlock mechanism strength (between the tibial tray and tibial insert), shear fatigue
5
strength of the tibial insert post, contact pressures and areas, lateral subluxation of patellar component, knee constraint tests, jump distance test and range of motion performance. Test results indicate that the ASK System performs as well as the predicate Acculoc Total Knee System and is capable of withstanding expected in vivo loading without failure. Biocompatibility risk assessment and pyrogenicity testing has also been conducted.
9. Conclusion
The ASK System is substantially equivalent to legally marketed predicates.