(27 days)
No
The summary describes a mechanical knee implant and its material composition, with no mention of AI or ML technology.
Yes.
The device is indicated for relief of pain and improved knee function, which are therapeutic outcomes.
No
Explanation: The Acculoc Total Knee System, including the Acculoc Tibial tray, is an orthopedic implant designed for knee arthroplasty to replace damaged joints. It is a treatment device, not a diagnostic one. Its purpose is to relieve pain and improve function, not to identify or characterize a medical condition.
No
The device description clearly states it is a component of a "Total Knee System" consisting of physical implants (Femoral component, Tibial tray, Tibial Insert, Patella components) and instrumentation. The submission is specifically for a change in material for the Tibial tray, which is a physical hardware component.
Based on the provided text, 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 knee joint to relieve pain and improve function in patients with various knee conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a component of a "Total Knee System" consisting of physical implants (femoral component, tibial tray, tibial insert, patella components) and instrumentation for surgical use. This is consistent with a surgical implant.
- No mention of in vitro testing: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Performance Studies: The performance studies mentioned are mechanical testing (fatigue testing) and pyrogenicity testing, which are relevant to the safety and durability of a surgical implant, not the diagnostic accuracy of an IVD.
In summary, the Acculoc Total Knee System is a surgical implant intended for knee replacement, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Acculoc Total Knee System is indicated in knee arthroplasty for 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
JWH
Device Description
The Acculoc Tibial tray is a component of "Acculoc Total Knee System" cleared under K170753 which consist of Femoral component, Tibial tray, Tibial Insert, Patella components and Instrumentation- Acculoc Total Knee Instrumentation System for use with the implants components.
The current premarket notification is related to the addition of the Acculoc Tibial tray manufactured from CoCrMo alloy (Cobalt-chromium-molybdenum alloy), this is same size and same design with the predicate device tibial tray (K170753) and only the material is different.
The Tibial tray AP and ML size ranges are exact same as the predicate device Tibial tray (K170753).
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)
Performance testing was carried out to demonstrate substantial equivalence and included methods described in the following standards: ASTM F1800/ISO14879-1. Mechanical testing of the subject device consisted of fatigue testing and performed similar to the predicate device/s and pyrogenicity testing has been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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.
September 27, 2018
RootLoc Co., Ltd. Jungsun Ha RA Specialist #1206, 1210, 68, Digital-ro 9-gil Geumcheon-gu. Seoul. 08512. Korea
Re: K182370
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: August 28, 2018 Received: August 31, 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. 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
1
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.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Peter G. Allen -S 2018.09.27 11:34:52 -04'00'
- Mark N. Melkerson FOR Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182370
Device Name Acculoc Total Knee System
Indications for Use (Describe)
The Acculoc Total Knee System is indicated in knee arthroplasty for 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) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Special 510(k) SUMMARY
The following Special 510(k) summary is being submitted as required by 21 CFR 807.92(a):
| Submitter: | RootLoc Co., Ltd.
#1206, 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: | August 28, 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 Class II device. |
3. Purpose of 510(k)
The RootLoc Co., Ltd. here by submits this Special 510(k) for adding CoCrMo alloy(ASTM F75) Tibial tray with the same size and design as the predicate device cleared under Acculoc Total Knee System (K170753).The intended use of the added (Acculoc Tibial tray) has not changed as result of addition.
4. Indication for Use
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
4
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.
5. Predicate or legally marketed devices which are substantially equivalent Predicate:
Primary predicate: Acculoc Total Knee System (K170753) Reference predicate: Corentec EAUM/LOSPA TKR System (K110404, K130673)
Description of the Device 6.
The Acculoc Tibial tray is a component of "Acculoc Total Knee System" cleared under K170753 which consist of Femoral component, Tibial tray, Tibial Insert, Patella components and Instrumentation- Acculoc Total Knee Instrumentation System for use with the implants components.
The current premarket notification is related to the addition of the Acculoc Tibial tray manufactured from CoCrMo alloy (Cobalt-chromium-molybdenum alloy), this is same size and same design with the predicate device tibial tray (K170753) and only the material is different.
The Tibial tray AP and ML size ranges are exact same as the predicate device Tibial tray (K170753).
| Product | Material | Standard |
|---|---|---|
| Femoral | ||
| component | CoCrMo Alloy | ASTM F75 |
| Tibial Tray | ||
| component | Ti-6Al-4V ELI | ASTM F136 |
| CoCrMo Alloy (Added) | ASTM F75 | |
| Tibial Insert | ||
| component | UHMWPE (GUR 1050) | ASTM F648 |
| Patella | ||
| component | UHMWPE (GUR 1050) | ASTM F648 |
Acculoc Total Knee system Materials:
- Comparison of the technological characteristics of the subject and 7. predicate devices
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Acculoc Tibial tray is substantially equivalent in indications and design principles to the predicate devices, each of which has been determined by FDA to be substantially equivalent as below
- Primary predicate: Acculoc Total Knee System (K170753)
- Reference predicate: Corentec EAUM/LOSPA TKR System (K110404, o K130673)
8. Performance Testing
Performance testing was carried out to demonstrate substantial equivalence and included methods described in the following standards: ASTM F1800/ISO14879-1. Mechanical testing of the subject device consisted of fatigue testing and performed similar to the predicate device/s and pyrogenicity testing has been conducted.
9. Conclusion
The Acculoc Tibial tray has similarities to the predicate device/s with the same intended use, same fundamental scientific technology, same operating principles, same material and are same sterile.