(89 days)
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No
The document describes a mechanical knee implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described for the treatment of various joint diseases and fractures, indicating a therapeutic purpose.
No
The document describes a knee implant system used for treatment of joint diseases and fractures, not for diagnosing conditions.
No
The device description clearly details physical components made of wrought Ti-6Al-4V and commercially pure titanium, indicating it is a hardware device, not software-only.
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, or tissue) to provide information about a person's health.
- Device Description: The provided description clearly describes a knee implant (resurfacing and pegged tibial components) used for surgical implantation to treat various knee joint conditions.
- Intended Use: The intended use is to treat degenerative joint diseases and fractures, which are conditions addressed through surgical intervention, not through the analysis of bodily specimens.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The indications for use of these tibial inserts are noninflammatory Indications: degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, theumatoid arthritis, treatment of fractures that are unmanageable using other techniques. This device is for cemented use only.
Product codes
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Device Description
The resurfacing and pegged tibial components are available in six sizes, articulate with the existing Foundation® Knee System. The baseplates are fabricated from wrought Ti-6Al-4V that conforms to ASTM F136. The under side of both baseplates is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance cement fixation. The resurfacing baseplate has four smooth pegs and two screw holes to allow the use of 6.5 mm cancellous type screws. The resurfacing component has a notch cut out posteriorly to allow retention of the posterior cruciate ligament. The stemmed tibial baseplate has a stem for rotational stability and four screw holes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee joint
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 (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
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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
Summary of Safety and Effectiveness
Encore Orthopedics®, Inc. 9800 Metric Blvd. Austin, TX 78758 512-834-6237 Ashley M. Bock
APR - 2 1997
Trade Name: Tibial Component
Common Name: Tibial Component
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis.
Description: The resurfacing and pegged tibial components are available in six sizes, articulate with the existing Foundation® Knee System. The baseplates are fabricated from wrought Ti-6Al-4V that conforms to ASTM F136. The under side of both baseplates is plasma sprayed with commercially pure titanium to provide a roughened surface to enhance cement fixation. The resurfacing baseplate has four smooth pegs and two screw holes to allow the use of 6.5 mm cancellous type screws. The resurfacing component has a notch cut out posteriorly to allow retention of the posterior cruciate ligament. The stemmed tibial baseplate has a stem for rotational stability and four screw holes.
The indications for use of these tibial inserts are noninflammatory Indications: degenerative joint disease including osteoarthritis or traumatic arthritis, avascular necrosis of the femoral condyle, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus or flexion deformities, theumatoid arthritis, treatment of fractures that are unmanageable using other techniques. This device is for cemented use only.
Comparable Features to Predicate Device is similar in features, design and indications as the Foundation® Primary Knee System (K923277) and Biomet Maxim® Knee System.