(80 days)
Not Found
No
The summary describes a traditional knee implant 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 knee system intended for unicompartmental knee arthroplasty to treat painful osteoarthritis or post-traumatic arthritis, correct functional deformities, and revise previous unsuccessful knee replacements, all of which are therapeutic interventions.
No
This device is a knee implant system intended for unicompartmental knee arthroplasty, which is a treatment for joint disease, not a tool for diagnosing it.
No
The device description explicitly states that the system consists of physical components (femoral component, tibial tray, and tibial insert) made of Cobalt Chrome and polyethylene, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the ACCIN UNI-Knee System components are for implantation in the knee. They are physical prostheses designed to replace damaged joint parts.
- Intended Use: The intended use describes surgical procedures for treating knee joint disease and deformities. This is a surgical implant, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- Correction of functional deformities;
- Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
These components are single use only and are intended for implantation with bone cement.
Product codes
HSX
Device Description
The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and tibial tray and a polyethylene tibial insert.
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
Tests were performed on the ACCIN UNI-Knee System as compared to the Stelkast Unicondylar Knee System. The tests performed can be found in the guidance document entitled "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial MetalPolymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The results provided in the testing section of this submission demonstrate that the proposed ACCIN UNI-Knee System is equivalent to the predicate device Stelkast Unicondylar Knee System.
Key Metrics
Not Found
Predicate Device(s)
EIUS Unicompartmental Knee System - K033769, K992287, Stelkast Unicondylar Knee System - K0032824, Zimmer Unicompartmental Knee System - K033363
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Summary of Safety and Effectiveness
| Submitter: | Michael Kvitnitsky
ACCIN Corporation
1033 US Highway 46, Suite A204
Clifton, NJ 07103 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 18, 2006 |
| Device: | ACCIN UNI-Knee System |
| Classification: | 87 HSX - Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal
Polymer, 21 CFR 888.3520, Class II |
| Predicate Device: | EIUS Unicompartmental Knee System - K033769 and K992287
Stelkast Unicondylar Knee System - K0032824
Zimmer Unicompartmental Knee System - K033363 |
| Device Description: | The ACCIN UNI-Knee System consists of Cobalt Chrome femoral component and
tibial tray and a polyethylene tibial insert. |
| Intended Use: | The ACCIN UNI-Knee System components are for use in Unicompartmental knee
arthroplasty as a result of:
Moderately disabling joint disease of the knee resulting from painful osteoarthritis
or post traumatic arthritis; Correction of functional deformities; Revision of previous unsuccessful unicompartmental knee replacement or other
procedure; As an alternative to tibial osteotomy in patients with unicompartmental
osteoarthritis. JUN - 2 2006 |
These components are single use only and are intended for implantation with bone cement.
Comparison to Predicates:
The ACCIN UNI-Knee system consists of cobalt chrome femoral and tibial components and a polyethylene insert. The device is similar to the Stelkast Unicondylar Knee System, the EUIS Unicompartmental Kryle system and the Zimmer High Flex Unicompartmental Knee System. All three devices are for use in unicompartmental knee replacement. The Zimmer product and the proposed ACCIN device have a metal tibial tray and a UHMWPE tibial insert; whereas the EUIS system and the Stelkast system have an all-polyethylene tibia.
ACCIN Corporation has determined that the minor differences in the proposed device will not impact the safety or effectiveness of the unicompartmental knee system for its intended use. Testing has shown that the proposed device is equivalent to the predicate device.
Synopsis of Test Methods and Results:
Tests were performed on the ACCIN UNI-Knee System as compared to the Stelkast Unicondylar Knee System. The tests performed can be found in the guidance document entitled "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial MetalPolymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." The results provided in the testing section of this submission demonstrate that the proposed ACCIN UNI-Knee System is equivalent to the predicate device Stelkast Unicondylar Knee System.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2006
ACCIN Corporation % Mr. Michael Kvitnitsky 1033 US Highway 46 East Suite A204 Clifton, New Jersey 07013
Re: K060670
Trade/Device Name: ACCIN UNI-Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX Dated: March 06, 2006 Received: March 14, 2006
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.
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
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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 Office of Compliance at (240)-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Lerner
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 5 -- Mr. Michael Kvitnitsky
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OC Numbers:
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| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
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Indications for Use Form
510(k) Number (if known):_
Device Name: ACCIN UNI-Knee System
Indications for Use:
Indications for Use:
The ACCIN UNI-Knee System components are for use in Unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post . traumatic arthritis;
- Correction of functional deformities; .
- Revision of previous unsuccessful unicompartmental knee replacement or other . procedure:
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis. .
These components 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)
2
Herbert Lerner
Division of General, Restorative, and Neurological Devices
510(k) Number K060670
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