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The LINK® TrabecuLink® Tibial Cones are indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis and joint fractures which disallow an osteosynthetic reconstruction.

The LINK® TrabecuLink® Tibial Cones are indicated for the following conditions:

· Surgeries which require implantation of a total knee endoprosthesis after severe degeneration or bone loss, traumata or other pathologies.

The device is intended for uncemented use.

The LINK® TrabecuLink® Tibial Cones are designed to be used in conjunction with the LINK® Endo-Model® Knee System Standard / Modular / Porex® coated (K143179; K152431) and with the Endo- Model® SL® Knee System (K151008) tibial components. The subject device is intended to fill small to medium bone defects and provide a stable platform for the tibial articulating components.
The tibial cones are manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6Al4V, ISO 5832-3). The tibial cones consist of a non-porous bulk interior surface and a trabecular structure made of titanium (LINK® TrabecuLink®) on the external surface.
The LINK® TrabecuLink® Tibial Cones provide cementless fixation to the bone. The subsequently implanted knee endoprosthesis is cemented to the tibial cone.

This document describes the LINK® TrabecuLink® Tibial Cones, a medical device used in total knee replacement surgeries. It does not describe an AI/ML device, and therefore, the information typically requested about AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for training sets) is not applicable here.

The document focuses on demonstrating the substantial equivalence of the device to legally marketed predicate devices through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter and 510(k) summary do not present formal "acceptance criteria" for performance in a table format with specific numerical targets. Instead, they refer to "non-clinical performance testing and analysis" which demonstrate that the device is "as safe, as effective and substantially equivalent to the predicate device." The "acceptance" is implicitly that the device performs comparably to the predicate devices in these tests.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. This refers to non-clinical bench testing, not a dataset of patient cases.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this was non-clinical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable, as this was non-clinical bench testing. Performance was assessed against engineering and material science standards and comparison to predicate devices, not expert human interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable, as this was non-clinical bench testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For non-clinical performance, the "ground truth" or reference for assessment would be established engineering and material science standards, specifications, and direct comparison to the performance characteristics of the predicate devices. There is no biological "ground truth" (like pathology or outcomes data) established for these specific tests, as they are mechanical and material characterizations.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, and no training set was used.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device.

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The Instruments for LINK® MEGASYSTEM-C® Family are intended to aid in intra-operative implantation of the LINK® MEGASYSTEM-C® (K151008), which can be integrated with the components of the Endo-Model® SL® Rotating and Non- Rotating Hinge Knee or Endo-Model® Knee System (#K143179) for knee replacement, and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement. The LINK® MEGASYSTEM-C® (K151008), has the following indications:

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:

1. Revision for loosened femoral prosthesis components involving extensive bone loss;
2. Surgical intervention for severe trauma;
3. 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 Hinge Knee System additional indications should be noted:

1. Bone necroses.
2. Bicondylar arthrosis by partly damaged collateral ligaments.
3. Revision surgery after primary total knee replacement.
4. Revision surgery after rotating or non-rotating hinged knee replacement.
5. Revision surgery by insufficient / inadequate bone mass.
6. Arthrosis of patella flange.
7. 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).

This is a duplicate 510k and line extension in Link Bio Corp.'s name for the accessory instrument system previously cleared in K151008 by Waldemar Link GmbH & Co KG for use with/as accessories to the LINK® MEGASYSTEM-C® and 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). It includes the same instruments as in K151008, and additional accessory instruments (line extension).

The provided text describes a 510(k) premarket notification for surgical instruments used in knee and hip replacement (Trade/Device Name: Instruments for LINK® MEGASYSTEM-C® Family). This submission is a duplicate 510(k) and line extension for accessory instruments previously cleared under K151008.

Based on the provided document, the device in question is a set of manual reusable surgical instruments, not an AI/ML-driven device or a device that generates diagnostic data that would typically have acceptance criteria related to sensitivity, specificity, or similar performance metrics. The document explicitly states:

"Extensive performance testing was provided in K151008 for the implant system, but is not required for the accessory instruments."

And regarding technological characteristics:

"The accessory instruments presented in K151008 are exactly replicated in this duplicate 510k. Additional reusable manual surgical instruments included as a line extension are for the same purpose (to support implantation of the same Waldemar Link GmbH implant systems) as the existing instrument system, with no significant differences in technological features, materials, or intended use."

Therefore, the following information cannot be extracted from this document as it pertains to AI/ML or data-driven diagnostic devices, which this product is not:

• Acceptance criteria and reported device performance (in terms of diagnostic accuracy or similar metrics)
• Sample size for the test set and data provenance
• Number of experts and their qualifications for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to a predicate device (K151008) based on the instruments being identical or having minor design modifications that do not change their intended use or function. No "study" in the sense of a clinical trial or performance evaluation against specific diagnostic metrics is mentioned for these instruments.

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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:

1. Revision for loosened femoral prosthesis components involving extensive bone loss;

2. Surgical intervention for severe trauma;

3. 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:

1. Bone necroses.

2. Bicondylar arthrosis by partly damaged collateral ligaments.

3. Revision after primary total knee replacement.

4. Revision surgery after hinge knee or rotational knee joint.

5. Revision surgery by insufficient / inadequate bone mass.

6. Arthrosis of patella flange.

7. 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.

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.

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