(133 days)
The LINK® MEGASYSTEM-C® is intended to be used with the components of the Endo-Model® SL® Rotating and Non-Rotating Hinge Knee or Endo-Model® Knee System (#K143179) which can be integrated for knee joint replacement and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement.
The LINK® MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures:
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Revision for loosened femoral prosthesis components involving extensive bone loss;
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Surgical intervention for severe trauma;
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Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;
The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.
For the use of the LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge Knee System additional indications should be noted:
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Bone necroses.
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Bicondylar arthrosis by partly damaged collateral ligaments.
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Revision after primary total knee replacement.
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Revision surgery after hinge knee or rotational knee joint.
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Revision surgery by insufficient / inadequate bone mass.
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Arthrosis of patella flange.
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Valgus/Varus deformities
The LINK® MEGASYSTEM-C® is comprised of a number of components that are intended to be used in conjunction with each other, or in conjunction with components of LINK® Endo-Model® SL® Rotating and Non- Rotating Hinge Knee, LINK® Endo-Model® Knee System (#K143179) and LINK® MP® Reconstruction Prosthesis (#K142187)
There are three (3) modules of the MEGASYSTEM-C®:
- Proximal Femur
- Distal Femur / Proximal Tibia
- Total Femur
The system allows partial bone replacements both in the proximal and distal femur in small increments as well as a total replacement of the femur. For the knee joint components, the Endo-Model® SL® Rotating Hinge Knee is used in the MEGASYSTEM-C®.
The LINK® MEGASYSTEM-C® is produced of Cobalt Chromium Molybdenum casting alloy (CoCrMo) and Ultra high molecular weight polyethylene (UHMWPE/noncrosslinked). The Modular Stems (cemented) and the Pushthrough stems are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials. The Modular Stems (cementless) are made of Titanium-Aluminum-Vanadium alloy (Ti-6A1-4V) materials.
Stem Segments, Coupling for diaphyseal spacer and Support Ring are produced of Titanium-Aluminum-Vanadium alloy (Ti-6Al-4V). Coupling components and the knee fusion nail are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.
Femoral Segments and Proximal Tibial Spacers are produced of Titanium-Aluminum-Vanadium alloy (Ti-6Al-4V) and respectively of Ultra high molecular weight polyethylene (UHMWPE/non-crosslinked).
This document describes a 510(k) premarket notification for the LINK® MEGASYSTEM-C® total knee and hip revision prosthesis. It asserts substantial equivalence to a predicate device, the GMRS™ Global Modular Replacement System.
Here's a breakdown of the requested information based on the provided text, focusing on the device's performance given that it is a physical implant and not an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a medical device (prosthesis) and not an AI/ML system, the "acceptance criteria" pertain to mechanical and material performance rather than typical AI metrics like accuracy, sensitivity, or specificity. The document references specific ISO and ASTM standards and then reports that the device passed these tests.
| Test / Performance Metric | Acceptance Criteria (Implied by standard and successful completion) | Reported Device Performance |
|---|---|---|
| Tibial Bearing Component wear test | Per ISO 14243-1 and -2 | Successfully completed (implied, as conclusion states device is safe and effective) |
| Tibiofemoral contact area / stress analyses (at different angles) | Per ISO 14243-1 and -2 | Successfully completed (implied, as conclusion states device is safe and effective) |
| Tibial Baseplate Component fatigue test | Per ISO 14879 and ASTM F1800 | All Endo-Model® SL® Knee System test samples completed 10 million cycles without evidence of fracture or cracking. |
| Femoral neck segment fatigue test | Per ISO 7206-6 | Successfully completed (implied, as conclusion states device is safe and effective) |
| Femoral stem fatigue test | Per ISO 7206-4 | Successfully completed (implied, as conclusion states device is safe and effective) |
| Proximal femoral components fatigue test | Per ASTM F2580 | Successfully completed (implied, as conclusion states device is safe and effective) |
| Modular Connections, Fretting, and Corrosion Testing | Per ASTM F1875-98 | Successfully completed (implied, as conclusion states device is safe and effective) |
| Range of Motion analyses (MEGASYSTEM-C® and Endo-Model® SL® Knee) | (No specific standard mentioned for acceptance, but performed) | Successfully completed (implied, as conclusion states device is safe and effective) |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "test samples" for mechanical testing, but does not specify a numerical sample size for each test. For example, it states "All Endo-Model® SL® Knee System test samples completed the 10 million cycles Tibial Baseplate Fatigue Strength testing." It does not specify if "all" means 3, 5, or more samples.
- Sample Size: Not explicitly stated numerically for each test; refers to "test samples."
- Data Provenance: Non-clinical (laboratory/mechanical testing). No mention of country of origin for the "data" itself, beyond the device manufacturer being from Germany. The tests are based on international (ISO) and US (ASTM) standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This concept is not applicable to the submitted document. This review is for a physical medical device (prosthesis) that undergoes mechanical and material testing, not an AI/ML diagnostic or predictive system that requires expert consensus for ground truth. The "ground truth" for these tests is defined by the physical behavior of the materials and constructs under controlled laboratory conditions as per the standards.
4. Adjudication Method for the Test Set
Not applicable. This is not a study assessing interpretations or diagnoses where adjudication would be necessary. The tests are objective mechanical measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This is a physical medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" is established by adherence to recognized international and national standards for material science and biomechanical testing (e.g., ISO 14243-1, ISO 14243-2, ISO 14879, ASTM F1800, ISO 7206-6, ISO 7206-4, ASTM F2580, ASTM F1875-98). The physical properties and performance under specified test conditions are the objective "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.