(77 days)
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No
The 510(k) summary describes a mechanical implant (femoral component and spacers) for total knee replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a component of a total knee replacement system, which is a medical procedure aimed at treating conditions like inflammatory or noninflammatory joint disease, failed previous prosthesis, or trauma to alleviate symptoms and restore function. This classifies it as a therapeutic device.
No.
The device is a femoral component and femoral spacers for a total knee replacement system, used in surgical procedures. Its intended use is to replace joint components due to disease or trauma, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly indicates it is a "Femoral Component and Femoral Spacers," which are physical implants used in total knee replacement procedures. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers are components of a total knee replacement system. They are implanted directly into the body during surgery to replace damaged parts of the knee joint.
- No Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
This device is an implantable medical device used in surgical procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers are intended to be used with Kinemax® and Kinemax® Plus tibial and patellar components as a total knee These components are intended to be used in total knee svstem. replacement procedures indicated due to inflammatory or noninflammatory joint disease, failed previous prosthesis, or trauma.
Specifically, this femoral component is intended to be used in situations where a stemmed component is desired to provide additional stability. This femoral component allows the surgeon to use (as an option) femoral spacers to augment bone loss on the distal or distal/posterior surfaces of the femur.
These components are intended to be implanted using bone cement.
Product codes
JWH
Device Description
Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee Joint (femur)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Hospital
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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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).
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§ 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
K963796
DEC 9 1996
510(k) Summarv
Device: Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers
Common Name: Modular Femoral Component and Femoral Spacers
Classification Name and Reference: 21 CFR 888.3560 Knee Joint patellofemorotibial semi-constrained cemented prosthesis
Proposed Requlatory Class: Class II
Device Product Code: JWH OR(87)
The Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers are intended to be used with Kinemax® and Kinemax® Plus tibial and patellar components as a total knee These components are intended to be used in total knee svstem. replacement procedures indicated due to inflammatory or noninflammatory joint disease, failed previous prosthesis, or trauma.
Specifically, this femoral component is intended to be used in situations where a stemmed component is desired to provide additional stability. This femoral component allows the surgeon to use (as an option) femoral spacers to augment bone loss on the distal or distal/posterior surfaces of the femur.
These components are intended to be implanted using bone cement.
The Kinemax® Plus Modular Stabilizer Femoral Component and Femoral Spacers are substantially equivalent to several other legally marketed devices. Examples of these are listed below:
- Kinemax® Plus Stabilizer Femoral Component (Howmedica -1. K910500)
- Duracon® Stemmed Stabilizer Femoral Component (Howmedica -2. K932070)
- Duracon® Femoral Spacers (Howmedica K920034) 3.
For information contact: Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterams Boulevard Rutherford, NJ 07070 (201) 507-7431 Telephone: (201) 507-6870 Fax: