(76 days)
Not Found
No
The document describes a mechanical implant (tibial spacers) made of metal alloy, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No.
The device is a component of a total knee replacement system used to augment the tibia during surgery, not to treat or cure a disease or condition as typically defined for a therapeutic device.
No
The device is a tibial spacer, intended for use in total knee replacement procedures to augment bone in cases of bone loss. Its function is structural (to provide stability) rather than diagnostic.
No
The device description clearly states the spacers are fabricated from cast Vitallium® alloy and the fixation screws and pegs are fabricated from wrought or cast Vitallium® alloy, indicating a physical hardware device.
Based on the provided information, 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 and Intended Use: The Kinemax® Plus Tibial Spacers are described as implants used in total knee replacement surgery. They are physically placed within the patient's body to augment bone and provide stability.
- Lack of Diagnostic Testing: The description does not mention any testing of biological samples or providing diagnostic information.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia.
Product codes
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Device Description
There are three types of spacers in the Kinemax® Plus Tibial Spacer System: a half spacer, a full spacer, and a full angled spacer. These spacers are fabricated from cast Vitallium® allov. The fixation screws and pegs used to secure these spacers to the tibial baseplates are fabricated from wrought or cast Vitallium® alloy. These products will be sold sterile.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
K915512, K884837, K872379, K915132, K922285, K896542, K901457, K903286, K914072
Reference Device(s)
Not Found
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
510(k) Summary
FEB 2 4 1997
Device: Kinemax® Plus Tibial Spacers
The Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia.
There are three types of spacers in the Kinemax® Plus Tibial Spacer System: a half spacer, a full spacer, and a full angled spacer. These spacers are fabricated from cast Vitallium® allov. The fixation screws and pegs used to secure these spacers to the tibial baseplates are fabricated from wrought or cast Vitallium® alloy. These products will be sold sterile.
The Kinemax® Plus Tibial Spacers are substantially equivalent to other legally marketed products. Examples of these products are listed below:
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- Duracon® Tibial Wedges - Howmedica (K915512)
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- Kinemax® Angled Tibial Wedge - Howmedica (K884837)
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- Insall-Burstein II Half and Full Tibial Wedges -Zimmer (K872379)
- ട. CKS Tibial Spacers - Techmedica (K896542, K901457, K903286, and K914072)
An analysis of equivalent features was presented.
For information contact:
Margaret F. Crowe Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7431 Facsimile: (201) 507-6870