(71 days)
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No
The device description focuses on the materials and mechanical design of knee replacement components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a total knee replacement system intended to treat painful and disabling joint diseases of the knee, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a total knee replacement system, which is an implantable prosthetic used to treat severe knee joint disease. Its purpose is to replace deteriorated knee components and restore function, not to identify or diagnose a medical condition.
No
The device description clearly details physical components made of cobalt chromium alloy and ultra-high molecular weight polyethylene (UHMWPE), which are hardware materials for knee replacement implants. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The device described is a total knee replacement system consisting of implants (femoral components, tibial components, and patellar components) made from materials like cobalt chromium alloy and ultra-high molecular weight polyethylene. These are surgically implanted into the body.
- Intended Use: The intended use is to replace the articulating surfaces of the knee joint to treat painful and disabling joint diseases. This is a surgical intervention, not a diagnostic test performed on a sample outside the body.
Therefore, this device falls under the category of implantable medical devices rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
The indications for the use of these posteriorly stabilized total knee components, in keeping with those of other legally marketed Class II posteriorly stabilized total knee components, are as follows:
Indications:
- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, ● rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function. .
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure. .
- . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- . Absent or non-functioning posterior cruciate ligament.
Product codes
Not Found
Device Description
Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components
The Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are fabricated from cobalt chromium alloy, and are intended for cemented application to replace the articulating surface of the distal femur. These posteriorly stabilized femoral components are utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability.
The Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are available in right and left configurations, and with three different interior surface textures to supplement the cement fixation of the device: basic grit-blasted surface roughness, waffle pattern, and MicroStructured® porous coating. The Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are available either with or without nitrogen ion implanted bearing surfaces.
Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component
The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component is a one-piece total knee replacement tibial component, fabricated from ultra-high molecular weight polyethylene (UHMWPE). The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component, when used in conjunction with its mating Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Component, provides the constraint needed to compensate for an absent or incompetent posterior cruciate ligament.
The bearing surface of the Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component employs a single medial lateral (M/L) radius, and incorporates a posteriorly sloping, raised tibial eminence, a radiographic locator wire, and a swept back, keeled post. The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component is intended for cemented fixation. Primary fixation is to be achieved through interface of the bone cement with the tibial post.
Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert
The Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert is fabricated from ultra-high molecular weight polyethylene (UHMWPE). This tibial bearing insert is assembled to the tibial tray component intraoperatively via a locking wire mechanism.
The articulating surface area of the Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert is identical to that of the Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component.
Osteonics® Scorpio Total Knee All-Polvethylene Patellar Components
The Osteonics® Scorpio Total Knee All-Polyethylene Patellar Components are fabricated from ultra-high molecular weight polyethylene (UHMWPE), and are intended application onto the surgically prepared posterior patella. They replace the patellar articulating surface of the knee joint and simulate the natural anatomy and function of the knee.
The articular geometry is designed with a single medial lateral (M/L) radius. The overall geometry essentially consists of an oval patellar button configuration with three fixation pegs in the anterior surface of the component. The Osteonics® Scorpio Total Knee All-Polyethylene Patellar Components are available in three design configurations - Concentric Dome, Medialized Dome, and Superior-Medialized Dome.
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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
AUG 1 4 1996
Osteonics" Scorpio Posteriorly Stabilized Total Knee System
510(k) Premarket Notification
510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Osteonics Corporation 59 Route 17 Allendale. NJ 07401-1677 201-825-4900
Donna S. Wilson Regulatory Affairs Specialist
Contact Person:
Date Summary Prepared:
Device Identification
Proprietary Name:
Common Name:
Classification Name and Reference:
June 3, 1996
Osteonics® Scorpio Posteriorly Stabilized Total Knee System
Knee Prosthesis
Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis 21 CFR §888.3560
Predicate Device Identification
Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are substantially equivalent to the Osteonics® Series 7000 Total Knee Primary Posteriorly Stabilized Femoral Components. The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component is substantially equivalent to the Osteonics® Series 7000 Total Knee Primary Posteriorly Stabilized All-Polyethyleme Tibial Component. The Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert is substantially equivalent to the Osteonics® Series 7000 Total Knee Tibial Bearing Insert - P/S I Series. The Osteonics® Scorpio Total Knee All-Polyethylene Patellar Components are substantially equivalent to the Osteonics® Series 7000 Total Knee Resurfacing Patellar Components.
1
Device Description
Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components
The Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are fabricated from cobalt chromium alloy, and are intended for cemented application to replace the articulating surface of the distal femur. These posteriorly stabilized femoral components are utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability.
The Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are available in right and left configurations, and with three different interior surface textures to supplement the cement fixation of the device: basic grit-blasted surface roughness, waffle pattern, and MicroStructured® porous coating. The Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Components are available either with or without nitrogen ion implanted bearing surfaces.
Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component
The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component is a one-piece total knee replacement tibial component, fabricated from ultra-high molecular weight polyethylene (UHMWPE). The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component, when used in conjunction with its mating Osteonics® Scorpio Total Knee Posteriorly Stabilized Femoral Component, provides the constraint needed to compensate for an absent or incompetent posterior cruciate ligament.
The bearing surface of the Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component employs a single medial lateral (M/L) radius, and incorporates a posteriorly sloping, raised tibial eminence, a radiographic locator wire, and a swept back, keeled post. The Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component is intended for cemented fixation. Primary fixation is to be achieved through interface of the bone cement with the tibial post.
Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert
The Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert is fabricated from ultra-high molecular weight polyethylene (UHMWPE). This tibial bearing insert is assembled to the tibial tray component intraoperatively via a locking wire mechanism.
The articulating surface area of the Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert is identical to that of the Osteonics® Scorpio Total Knee Posteriorly Stabilized All-Polyethylene Tibial Component.
Osteonics® Scorpio Total Knee All-Polvethylene Patellar Components
The Osteonics® Scorpio Total Knee All-Polyethylene Patellar Components are fabricated from ultra-high molecular weight polyethylene (UHMWPE), and are intended application
2
Osteonics" Scorpio Posteriorly Stabilized Total Knee System
onto the surgically prepared posterior patella. They replace the patellar articulating surface of the knee joint and simulate the natural anatomy and function of the knee.
The articular geometry is designed with a single medial lateral (M/L) radius. The overall geometry essentially consists of an oval patellar button configuration with three fixation pegs in the anterior surface of the component. The Osteonics® Scorpio Total Knee All-Polyethylene Patellar Components are available in three design configurations - Concentric Dome, Medialized Dome, and Superior-Medialized Dome.
Intended Use
The indications for the use of these posteriorly stabilized total knee components, in keeping with those of other legally marketed Class II posteriorly stabilized total knee components, are as follows:
Indications:
- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, ● rheumatoid arthritis or post-traumatic arthritis.
- Post-traumatic loss of knee joint configuration and function. .
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure. .
- . Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- . Absent or non-functioning posterior cruciate ligament.
Statement of Technological Comparison
The Osteonics® Scorpio Posteriorly Stabilized Total Knee System components share the same materials, indications and intended use, surgical techniques, basic design features, and basic manufacturing methods of their respective predicate devices. These components are substantially equivalent to predicate devices by virtue of providing for cemented application of the femoral, patellar, and all-polyethylene tibial components, security of fixation, proper load transfer, and a biomechanical function and range of motion which approximate the normal knee when used in conjunction with each other and/or the associated Osteonics® Series 7000 Total Knee Tibial Trays and Osteonics® Omnifit Total Knee Tibial Trays, as applicable. Although the articulating surfaces of the subject devices differ slightly from that of their predicate devices, applicable performance testing demonstrates that no significant difference exists between these components and their predicate designs.