(72 days)
Not Found
No
The summary describes a mechanical knee implant system and its line extension, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for use in unicompartmental knee arthroplasty to treat painful osteoarthritis or traumatic arthritis, which are medical conditions, thus providing therapy.
No
Explanation: The device is an orthopedic implant (Unicompartmental Knee System) intended for use in unicompartmental knee arthroplasty, not for diagnosing medical conditions.
No
The device description explicitly states it includes additional tibial components made of polyethylene material, which are physical implants, not software.
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 unicompartmental knee arthroplasty. This is a procedure performed in vivo (within the body) to replace a damaged joint.
- Device Description: The device is described as a knee system with tibial components made of polyethylene material, intended for implantation with bone cement. This is consistent with a surgical implant, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a prosthetic implant used to replace a damaged joint.
N/A
Intended Use / Indications for Use
The EIUS® Unicompartmental Knee System is intended for use in unicompartmental kncc arthroplasty. It is intended to be used for patients with moderately disabling joint discase of the knee resulting from painful osteoarthritis or traumatic arthritis; revision of previous unsuccessful unicompartmental knec replacement or other procedure, or as an alternative to tibial osteotomy in patients with unicompartmental ostcoarthritis.
The FIUS® Knee System components are for use in Unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
- 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
87 HSX
Device Description
This submission is intended to address a line extension to the EUS® Unicompartmental Knee System. The linc cxtension includes additional tibial components, 8mm, 10mm, and 12mm components without a keel and 6mm components with and without a keel. Also, some changes werc made to the cement recess of the tibial component to ensure adequate thickness under the femoral condyle. Finally, the material will change from the current polycthylene material to the polyethylene material used in the Scorpio Knee System. The new components will be used for resurfacing of either the medial or lateral proximal tibia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, proximal tibia (medial or lateral)
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)
Mechanical testing demonstrated comparable mechanical properties to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K992287, K923011, K980665, K962152
Reference Device(s)
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
§ 888.3520 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
FEB 1 3 2004 Special 510(k) Summary of Safety and Effectiveness: Line Extension to the EIUS® Unicompartmental Knee System
| Proprietary Name: | EIUS® Unicompartmental Knee System |
|---|---|
| Common Name: | Unicompartmental Knee System |
| Proposed Regulatory Class: | Class II |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, | |
| Metal Polymer, 21 CFR 888.3520 | |
| Device Product Code: | 87 HSX |
| For Information contact: | Denise Duchene |
| Sr. Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Dr. | |
| Mahwah, NJ 07430 | |
| Telephone: (201) 831-5612 | |
| Fax: (201) 831-6038 | |
| Email: dduchene@howost.com) | |
| Date Summary Prepared: | November 12, 2003 |
Predicate Device Identification
The EIUS® Unicompartmental Knee System consists of femoral components and tibial components and the Scorpio Total Knee System consists of various femoral, tibial and patcllar components. The EIUS Unicompartmental Knec System additional tibial components are equivalcul to the currently marketed EIUS tibial components with the exception of the thickness, cement recess and material. The material is equivalent to the currently marketed Scorpio Knee System tibial inscrts; whereas the coment recess without a keel is equivalent to the UNIX Unicompartmental Knee and the Biomet Repicci Unicompartmental All Polycthylene Tibia component (also available without a keel). The EIUS Unicompartmental Knee System was determined substantially equivalent under K992287, the UNIX Unicompartmental Kncc was determined substantially equivalcnt under K923011, the Biomet component was cleared under K980665, and the Scorpio Total Kncc Tibial Insert components were determined substantially equivalent under K962152.
Description of Device Modification
This submission is intended to address a line extension to the EUS® Unicompartmental Knee System. The linc cxtension includes additional tibial components, 8mm, 10mm, and 12mm components without a keel and 6mm components with and without a keel. Also, some changes werc made to the cement recess of the tibial component to ensure adequate thickness under the femoral condyle. Finally, the material will change from the current polycthylene material to the polyethylene material used in the Scorpio Knee System. The new components will be used for resurfacing of either the medial or lateral proximal tibia.
Page 1 of 2
1
Intended Use:
The EIUS® Unicompartmental Knee System is intended for use in unicompartmental kncc arthroplasty. It is intended to be used for patients with moderately disabling joint discase of the knee resulting from painful osteoarthritis or traumatic arthritis; revision of previous unsuccessful unicompartmental knec replacement or other procedure, or as an alternative to tibial osteotomy in patients with unicompartmental ostcoarthritis.
Statement of Technological Comparison:
The subject components share the same intended use and basic design concept as that of the predicate devices. Mechanical testing demonstrated comparable mechanical properties to the predicate devices.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
Ms. Denise Duchene Senior Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K033769
Trade/Device Name: EIUS® Unicompartmental Knee System - Tibial Components Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX Dated: January 16, 2004 Received: January 20, 2004
Dear Ms. Duchene:
We have reviewed your Scction 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 Mcdical 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 - Ms. Denise Duchene
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
L. Mark A. Milburn
elia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K033769
Device Name: EIUS® Unicompartmental Knee System - Tibial Components
Indications For Use:
The FIUS® Knee System components are for use in Unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
- 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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
Mad A. Mellem
Restorative,
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510(k) Number K033769