(148 days)
Not Found
No
The device description focuses on the physical components and materials of a knee implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is an implantable knee component intended to treat degenerative or post-traumatic degenerative disease, effectively replacing a damaged part of the knee to restore function and alleviate symptoms.
No
This device is a Unicompartmental Knee, an implant for joint replacement, not a device used to diagnose medical conditions. Its intended use is for "medial compartment replacement of the articulating surface of the knee" due to degenerative disease or previous injuries.
No
The device description clearly outlines physical components made of Cobalt Chrome Alloy and UHMWPe, along with instruments and trials, 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 states that the device is a unicompartmental knee replacement for surgical implantation to treat degenerative or post-traumatic knee conditions. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components of a knee prosthesis (femoral and tibial components made of metal and plastic) and instruments for implantation. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
In summary, this device is a surgical implant used to replace a damaged part of the knee joint, not a device used to perform diagnostic tests in vitro.
N/A
Intended Use / Indications for Use
The Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty procedures. This device is intended for cemented use only.
Product codes
HRY
Device Description
The VOT Uni Knec consists of a femoral and a tibial component. The low profiled prosthesis is designed to be nonconstraining and to allow natural weight distribution and flexion. The anatomically designed femoral component is asymmetrically shaped conforming to the natural knee in the coronal and sagittal planes. The post and keel are designed to provide anteroposterior and mediolateral stability. Cobalt Chrome Alloy is used to fabricate the component which is available in three sizes. The tibial component is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPe). It incorporates a hemispherical shaped articular surface to replicate the natural knce. The component is nonconstraining and designed to allow natural weight distribution and flexion. Dovetailed channels on the undersurface allow for mechanical lock between the implant and the cement mantle. The thickness of the component under the area of the femoral-tibial articulation helps to improve longevity and to minimize the possibility of its fracture. The dual injection ports, the cement delivery instruments, synnge and adapter facilitate cement application. Nine sizes are available to enhance surgical latitude in preoperative planning. Tibial and femoral instruments and trials are also available to facilitate implantation.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K971938, K033363, K010685, K033769, K060412, K020264
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
K072704 # '12
..............................................................................................................................................................................
510(K) SUMMARY 3.
Valpo Orthopedic Technology, Inc. Applicant/Sponsor: 1. 438 E 200 N Warsaw, IN 46582
- പ്പ് 5 3 9 Contact Person: Hans Stover 2. President & CEO hstover@votechnology.com Phone (574) 269-4103, Ext 222
-
- Proprietary Name: Unicompartmental Knee
- Common Name: Unicondylar Knee 4.
- Classification Name: 5. Knee joint, femorotibial metal/polymer semi-constrained cemented Prosthesis (21 CFR 888.3530)
- Legally Marketed Devices to which Substantial Equivalence is Claimed:
- Repicci II Unicompartmental Knee. (K971938) ત્વા
- Zimmer Unicompartmental Knee System (K033363) b.
- Miller /Galante Precoat Unicompartmental Knee (K010685) C.
- d. EIUS Unicompartmental Knee System -(K033769)
- Active Unicompartmental Kncc System-(K060412) .3
- f. Repicci II Unicondylar Knee System-(K020264)
-
- Device Description:
The VOT Uni Knec consists of a femoral and a tibial component. The low profiled prosthesis is designed to be nonconstraining and to allow natural weight distribution and
1
Image /page/1/Picture/0 description: The image shows a handwritten text string that appears to be a combination of alphanumeric characters. The string starts with 'K072704' followed by a number sign '#' and then '2/2'. The handwriting is somewhat stylized, with some characters slightly distorted or connected.
flexion. The anatomically designed femoral component is asymmetrically shaped conforming to the natural knee in the coronal and sagittal planes. The post and keel are designed to provide anteroposterior and mediolateral stability. Cobalt Chrome Alloy is used to fabricate the component which is available in three sizes. The tibial component is manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPe). It incorporates a hemispherical shaped articular surface to replicate the natural knce. The component is nonconstraining and designed to allow natural weight distribution and flexion. Dovetailed channels on the undersurface allow for mechanical lock between the implant and the cement mantle. The thickness of the component under the area of the femoral-tibial articulation helps to improve longevity and to minimize the possibility of its fracture. The dual injection ports, the cement delivery instruments, synnge and adapter facilitate cement application. Nine sizes are available to enhance surgical latitude in preoperative planning. Tibial and femoral instruments and trials are also available to facilitate implantation.
The VOT Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface of the knec when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty procedures. The device is intended for cement use only.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text reading "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three curved lines representing wings or streams.
Public Health Service
FEB 19 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Valpo Orthopedic Technology, Inc. % Mr. Hans Stover President & CEO 438 E 200 N Warsaw, Indiana 46582
Re: K072704 Trade/Device Name: Unicompartmental Knee Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint, femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: January 24, 2008 Received: January 25, 2008
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. Hans Stover
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 M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 2. | INDICATIONS FOR USE |
|---|---|
| ---- | --------------------- |
| 510(k) Number (if known): | N/A (unknown) K072704 |
|---|---|
| Device Name: | Unicompartmental Knee |
Indications for Use:
The Unicompartmental Knee is indicated for:
The Unicompartmental Knee is solely indicated for medial compartment replacement of the articulating surface of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty procedures. This device is intended for cemented use only.
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divison Sign-Off) 1 (Division Sign-On)
Division of General, Restorative,
Division of General, Devices Division of Secon Devices X072704 510(k) Number_________________________________________________________________________________________________________________________________________________________________