(179 days)
No
The summary describes a traditional total knee replacement system made of standard materials and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total knee system, implanted to treat painful and disabling joint disease of the knee, which is a therapeutic purpose.
No
This device is a total knee system, which is an orthopedic implant used for joint replacement, not for diagnosing conditions.
No
The device description explicitly states it consists of physical components made of cobalt chrome and UHMWPE, which are hardware materials.
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. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device components are described as implants (femoral, tibial tray, and tibial bearing components) made of materials suitable for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The ACCIN Total Knee System components are for use in total knee arthroplasty as a result:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic 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;
- Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
- Ligamentous instability requiring implant bearing surfaces with increased constraint;
- Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.
Product codes
JWH
Device Description
The Accin™ total knee system consists of a series of cobalt chrome femoral components, a series of cobalt chrome tibial tray components and a series of UHMWPE modular tibial bearing components.
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)
Numerous tests were performed on the Accin™ total knee system. The tests performed can be found in the FDA guidance documents on total knee arthroplasty devices and ASTM Standards F1800, F2083 and F1223. Testing has shown that the Accin™ total knee system meets the requirements of the current FDA Guidance documents on total knee arthroplasty product.
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 shows handwritten text that appears to be a combination of alphanumeric characters and symbols. The text includes 'K081127' followed by a number sign '#' and then '1/2'. The handwriting is somewhat cursive and the characters are clearly distinguishable.
OCT 1 7 2008
Summary of Safety and Effectiveness
| Submitter: | Michael Kvitnitsky
Accelerated Innovation, LLC
1033 US Highway 46, Suite A204
Clifton, NJ 07103 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 18, 2008 |
| Device: | Accin™ total knee system |
| Classification: | 87 JWH - Prosthesis, Knee, Patellofemoraltibial, Semi-Constrained, Cemented,
Polymer/Metal/Polymer - Class II (21 CFR 888.3560) |
| Predicate Device: | • Osteonics® Scorpio Posteriorly Stabilized Total Knee System (K962152)
• Osteonics® Scorpio Posterior Cruciate Retaining Total Knee System (K974556)
• Zimmer NexGen® Complete Knee Solution Legacy® Posterior Stabilized (LPS);
LPS-Flex Fixed Bearing Femoral and Articular Surface Components (K991581) |
| Device Description: | The Accin™ total knee system consists of a series of cobalt chrome femoral
components, a series of cobalt chrome tibial tray components and a series of
UHMWPE modular tibial bearing components. |
| Intended Use: | The ACCIN Total Knee System components are for use in total knee arthroplasty
as a result of:
• Painful, disabling joint disease of the knee resulting from degenerative
arthritis, rheumatoid arthritis or post-traumatic 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;
• Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
• Ligamentous instability requiring implant bearing surfaces with increased
constraint;
• Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone |
Comparison to Predicates:
The Accin™ total knee system consists of a series of cobalt chrome femoral components, a series of cobalt chrome tibial tray components and a series of UHMWPE modular tibial bearing components. The system is similar to the Osteonics Scorpio® Posteriorly Stabilized Total Knee System, the Osteonics Scorpio® Posterior Cruciate Retaining Total Knee System and the Zimmer LPS-Flex Fixed Bearing Femoral and Articular Surface Components. The trochlear region of the femoral component is designed to articulate with the Accin™ patellar component, previously approved under K073120. The predicate systems and the proposed system are both for use in total knee replacement surgery. Both the predicate systems and the proposed system have femoral components made from cobalt chrome and modular tibial bearing components made from UHMWPE. Both the predicate Scorpio Total Knee System and the proposed system have cobalt chrome tibial tray components.
. ...
1
K081122 #2/2
Accelerated Innovation, LLC has determined that the minor differences in the proposed device will not impact the safety or effectiveness of the total knee system for its intended use. Analysis has shown that the proposed device is equivalent to the predicate devices.
Synopsis of Test Methods and Results:
Numerous tests were performed on the Accin™ total knee system. The tests performed can be found in the FDA guidance documents on total knee arthroplasty devices and ASTM Standards F1800, F2083 and F1223. Testing has shown that the Accin™ total knee system meets the requirements of the current FDA Guidance documents on total knee arthroplasty product.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
OCT 1 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardo Medical Corporation % Mr. Michael Kvitnitsky 1033 US Highway 46 East, Suite A204 Clifton, New Jersey 07103
Re: K081127 Trade/Device Name: ACCIN Total Knce System Regulation Number: 21 CFR 888.3560 Regulation Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Regulatory Class: Class II Product Code: JWH Dated: October 09, 2008 Received: October 10, 2008
Dear Mr. Kvitnitsky
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Michael Kvitnitsky
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| Indications for Use Form | |
|---|---|
| 510(k) Number (if known): | K081127 |
|---|---|
| --------------------------- | --------- |
Device Name: __Accin™ total knee system
Indications for Use:
The ACCIN Total Knee System components are for use in total knee arthroplasty as a result of:
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid . arthritis or post-traumatic 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;
- . Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
- Ligamentous instability requiring implant bearing surfaces with increased constraint; .
- Absent or non-functioning posterior cruciate ligament. .
These devices are single use only and are intended for implantation with bone cement.
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restorative. and Neurologica
Page 1 of 1
Number K681127