(90 days)
The DePuy Graduated Compartmental Knee (GCK) is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
The GCK is indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces or a history of gout or pseudogout. All GCK components are intended for CEMENTED USE ONLY.
The DePuy GCK is composed of unicompartmental femoral components, patellofemoral trochlear components, unicompartmental tibial components and patellar components. These components may be used in various combinations to create: a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee; two unicompartmental femorotibial replacements for both the medial and lateral sides of the knee; a patellofemoral replacement; a bicompartmental patellofemorotibial replacement for the medial or lateral side of the knee; or a tricompartmental patellofemorotibial replacement for the medial and lateral sides of the knee.
The GCK unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).
This submission describes design modifications to the previously cleared GCK unicompartmental femoral components and all polyethylene unicompartmental tibial components.
This document describes the 510(k) summary for the DePuy GCK Femoral and Tibial Components, focusing on design modifications to previously cleared components.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (DePuy GCK, DePuy Sigma Unicompartmental Knee) | The modified GCK unicompartmental femoral and all polyethylene unicompartmental tibial components have the same indications and intended use, the same articulating geometry, the same sizes, and are manufactured from the same materials as the previously cleared GCK components. |
| Mechanical Integrity/Performance | Finite Element Analysis (FEA) performed to demonstrate substantial equivalence to predicate devices and other clinically successful designs. Specific results or quantitative acceptance criteria for FEA are not provided in this summary. |
| Intended Use/Indications | Deemed to have the "same indications and intended use" as predicate devices. Intended to provide increased patient mobility and reduced pain by replacing damaged knee joint articulation. Indicated for single or multi-compartmental knee replacement in skeletally mature individuals with osteoarthritis, posttraumatic arthritis, or a history of gout or pseudogout. All GCK components are for CEMENTED USE ONLY. |
| Material Equivalence | Manufactured from the "same materials" as the previously cleared GCK unicompartmental femoral and all polyethylene unicompartmental tibial components. |
| Geometric Equivalence (Articulating Geometry & Sizes) | Have the "same articulating geometry" and the "same sizes" as the previously cleared GCK components. |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. This submission relies on non-clinical testing (Finite Element Analysis) for substantial equivalence, not a clinical test set with patient data.
- Data Provenance: Not applicable for a clinical test set. The Finite Element Analysis would be computational data generated based on design specifications and material properties.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. As no clinical test set was used, no experts were involved in establishing ground truth for such a set. Substantial equivalence was primarily based on engineering analysis and comparison to predicate devices, which would have been reviewed by the FDA.
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Adjudication Method for the Test Set:
- Not applicable, as no clinical test set was evaluated.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. Clinical testing was explicitly stated as "not necessary to determine substantial equivalence."
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Standalone (Algorithm Only) Performance Study:
- Not applicable. This device is a physical knee implant, not an algorithm or AI system. Its performance is assessed through engineering analysis (FEA) and equivalence to established predicate devices.
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Type of Ground Truth Used:
- Engineering-based equivalence: The "ground truth" for this submission is established through demonstrating that the modified components are substantially equivalent to previously cleared and clinically successful predicate devices, based on their design, materials, intended use, and simulated mechanical performance (Finite Element Analysis). There is no "ground truth" in the sense of clinical outcomes or pathology for this specific submission, as clinical testing was not conducted.
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Sample Size for the Training Set:
- Not applicable, as this is a physical medical device and not an AI or algorithm that requires a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 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.