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The GEMINI SL Total Knee System is indicated for patients suffering from disability due to:
1 ) Degenerative, post-traumatic or rheumatoid arthritis;
2) Avascular necrosis of the femoral condyle;
3) Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
4) Moderate valgus, varus or flexion deformities.
This device may also be indicated in the salvage of previously failed surgical attempts.
The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use.

The Endo-Model and Sled Knee Systems with LINK PorEx (TiNbN) coating are indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatic arthrosis or arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. These devices are intended for cemented use only.
The Endo-Model Rotating Hinge and Modular Rotating Hinge Knee System with LINK PorEx (TiNbN) coating are indicated for the following conditions:

• 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 GEMINI SL Total Knee System is a semi-constrained, patellofemorotibial, cemented knee prosthesis. It is intended to replace the three articular portions of the knee joint. The system compromises two different designs: "Cruciate Retaining (CR)" and "Posterior Stabilized (PS)". Both versions consist of similar components: a Cobalt Chromium femoral component a polyethylene patella and a Cobalt Chromium tibial baseplate with an Ultra High Molecular Weight Polyethylene (UHMWPE / non-crosslinked) insert. The fixation of the tibial baseplate can be extended due to modular stems. The femoral and tibial components are made of CoCrMo and are available with PorEx surface modification.
The Endo-Model Knee System with LINK PorEx (TiNbN) coating is a constrained anti-luxation total knee prosthesis.
The Endo-Model Knee System consists of femoral and tibial components and modular stems. The modular stems are available in a variety of diameters and lengths in cemented version.
The Endo-Model Knee System is available in two (2) different knee joint versions:

• -Rotating Hinge Knee - Standard (Non-Modular) Version
• Rotating Hinge Knee Modular Version -
  The Endo-Model Knee System is produced of Cobalt Chromium Molybdenum casting alloy (CoCrMo) and Ultra high molecular weight polyethylene (UHMWPE / noncrosslinked). The modular stems (cemented) are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.
  The Sled Knee System with LINK PorEx (TiNbN) coating is a unicompartmental non-constrained knee replacement system. The Sled Knee is comprised of a set of implants and consists of a femoral component and a tibial component (allpolyethylene or metal-backed) and are available in different sizes.
  The femoral implant is made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) and is personalized to match a patient's anatomy.
  The all-poly tibial component is made from Ultra high molecular weight polyethylene (UHMWPE / non-crosslinked) and forgeable and cold-formed cobalt-chromium-nickel molybdenum-iron alloy (CoCrNiMoFe) X-ray wire. The metalbacked tibial component consists of a Cobalt Chromium Molybdenum casting alloy (CoCrMo) tibial tray and with an Ultra high molecular weight polyethylene (UHMWPE / noncrosslinked) tibial insert and cold-formed cobalt-chromiumnickel molybdenum-iron alloy (CoCrNiMoFe) X-ray wire. Multiple inserts of varying thickness may be provided to accommodate surgeon preferences.
  The change that is the subject of this Special 510(k) is to add the coating of Titanium Niobium Nitride (TiNbN) done by Waldemar Link inhouse to the above listed systems. The devices are already commercially available with TiNbN coating applied by an external vendor.
  There is no change to the fundamental scientific technology of the referenced knee systems with the modifications in this 510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufactured. All components are sterile and for single use only.

This document is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to previously cleared devices. It primarily details changes to manufacturing,
This document outlines a 510(k) premarket notification for knee replacement systems, specifically regarding an in-house Titanium Niobium Nitride (TiNbN) coating. It does not contain information about the acceptance criteria or a study proving device performance in the way requested. Here's a breakdown of why the requested information cannot be extracted from this text:

Missing Information:

• Acceptance Criteria and Reported Device Performance: This document does not provide specific acceptance criteria (e.g., minimum tensile strength, specific wear rate limits) for the device. Instead, it relies on substantial equivalence to predicate devices. There are no reported performance metrics for the device in the context of specific acceptance criteria.
• Sample Size, Data Provenance, Ground Truth Experts, Adjudication Method, MRMC Study, Standalone Study, Type of Ground Truth for Test Set, Training Set Size, Ground Truth for Training Set: The document explicitly states:
  • "There was no additional non-clinical performance testing required for the devices in scope."
  • "There was no clinical performance testing required for this device."

This means that a study with a test set, expert involvement, and ground truth establishment, as usually associated with evaluating device performance against acceptance criteria, was not performed for this specific 510(k) submission.

What the document does state regarding testing:

• Reliance on Predicate Testing: "System specific testing, with consideration to Draft Guidance For The Preparation of Premarket Notifications (510(k)s) for cemented, semi-constrained Total Knee Prostheses can be found in predicate 510(k)s #K152431 and #K182872."
• Coating-Specific Testing: "Testing considering the LINK PorEx (TiNbN) inhouse coating was done in #K202924." This implies that the coating itself was likely tested in the context of a different device previously cleared (LinkSymphoKnee System, K202924), and that testing is being referenced here rather than new testing for the current devices.

Conclusion:

Based on the provided text, a new study to demonstrate device performance against acceptance criteria was not conducted for this 510(k) submission. The FDA clearance is based on the device's substantial equivalence to existing predicate devices and prior testing of the "in-house" coating on another system. Therefore, I cannot provide the requested table and details about a specific study proving the device meets acceptance criteria from this text.

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