(375 days)
Not Found
No
The summary describes a mechanical knee implant system and its performance testing, with no mention of AI or ML technology.
Yes
The "Intended Use / Indications for Use" section states that the device is indicated "for reduction or relief of pain and/or improved knee function," which are therapeutic outcomes.
No
This device, the Acculoc Total Knee System, is a knee prosthesis designed for implantation in knee replacement surgery to restore function and relieve pain. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components (femoral component, tibial insert, tibial tray, patellar component) made of materials like polymer and metal, indicating it is a hardware medical device, not software-only.
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 replacing a damaged knee joint in patients. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details the physical components of a knee prosthesis (femoral component, tibial insert, tibial tray, patellar component) designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Acculoc Total Knee 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 Acculoc Total Knee System is designed for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Acculoc Total Knee System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a Patellofemorotibia, 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.
| 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 |
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 Acculoc Total Knee 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 Acculoc Total Knee System performs as well, or better than, the U2 Total Knee system , Progressive Orthopaedic Total Knee System ,LOSPA TKR System and NovoKnee Total Knee System and is capable of withstanding expected in vivo loading without failure. Biocompatibility risk assessment and pyrogenicity testing has 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.
K051640, K142649, K150783, K110404, K123339
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 23, 2018 RootLoc Co., Ltd. Jungsun Ha RA Specialist #1210, 68, Digital-ro 9-gil Geumcheon-gu, Seoul, 08512 Korea Re: K170753 Trade/Device Name: Acculoc Total Knee 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: January 31, 2018 Received: February 2, 2018
Dear Jungsun Ha:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K170753
Device Name Acculoc Total Knee System
Indications for Use (Describe)
The Acculoc Total Knee 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 Acculoc Total Knee System is designed for cemented use 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)
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
510(k) SUMMARY
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| Submitter: | RootLoc Co., Ltd.
#1210, 68, Digital-ro 9-gil
Geumcheon-gu, Seoul, 08512, Korea
Phone. 82-2-6941-4341
e-mail: jsha0314@gmail.com |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jungsun Ha |
| Date prepared: | March 15, 2018 |
2. Device Identification
| Trade Name | Acculoc Total Knee 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 RootLoc Co., Ltd. here by submits this traditional 510(k)
5. Description of the Device
The Acculoc Total Knee System is of the fixed bearing type with a posterior stabilized design and cruciate retained design. It is a Patellofemorotibia, polymer.metal/polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, tibial tray and patellar component. The femoral
4
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.
| Product | Material | Standard | |
|---|---|---|---|
| Femoral | CoCrMo Alloy | ASTM F75 | |
| component | |||
| Tibial Tray | Ti-6Al-4V ELI | ASTM F136 | |
| Tibial Insert | UHMWPE (GUR 1050) | ASTM F648 | |
| Patella | UHMWPE (GUR 1050) | ASTM F648 |
Materials:
Indication for Use 6.
The Acculoc Total Knee 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 Acculoc Total Knee System is designed for cemented use only.
Comparison of the technological characteristics of the subject and predicate 7. devices
The Acculoc Total Knee System has the same intended use and indications as the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System. The Acculoc Total Knee System is manufactured from the same, or better materials as the U2 Total Knee System, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee
5
Total Knee System. The range of sizes available for the Acculoc Total Knee System is the same as the range of sizes cleared for the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System. The Acculoc Total Knee System design is substantially similar to the U2 Total Knee system design, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System. Based on these similarities, the Acculoc Total Knee System believes that the Acculoc Total Knee System is substantially equivalent to the U2 Total Knee system, Progressive Orthopaedic Total Knee System, LOSPA TKR System and NovoKnee Total Knee System.
8. Performance Testing
The Acculoc Total Knee 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 Acculoc Total Knee System performs as well, or better than, the U2 Total Knee system , Progressive Orthopaedic Total Knee System ,LOSPA TKR System and NovoKnee Total Knee System and is capable of withstanding expected in vivo loading without failure. Biocompatibility risk assessment and pyrogenicity testing has been conducted.
9. Conclusion
The Acculoc Total Knee System is substantially equivalent to legally marketed predicates.