Search Results

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

The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System with 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 <10°
8. Valgus/Varus deformities 10-15°
9. Valgus/Varus deformities 15-20°

The LINK® Sled Knee System with PorEx® (TiNbN) coating is indicated for the following conditions:

1. Unicondylar arthrosis by intact ligaments including both cruciate ligaments
2. Valgus/Varus deformities <10°

The LINK® Endo-Model® Knee System is constrained anti-luxation total knee prosthesis. Retaining the low friction principle, the physiological movement of the rotational knee prosthesis is optimal Flexion and rotation of the rotational knee prosthesis take place in a cross joint.

The LINK® 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 LINK® 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 LINK® 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 LINK® Sled Knee is a unicompartmental nonconstrained knee replacement system. The LINK® Sled Knee is comprised of a set of implants and consists of a femoral component and a tibial component (all-polyethylene or metalbacked) 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 / nonand forgeable and cold-formed cobaltcrosslinked) chromium-nickel molybdenum-iron alloy (CoCrNiMoFe) Xray wire. The metal-backed tibial component consists of a Cobalt Chromium Molybdenum casting alloy (CoCrMo) tibial tray and with an Ultra high molecular weight polyethylene (UHMWPE / non-crosslinked) tibial insert and cold-formed cobalt-chromium-nickel 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 510(k) is to add the coating of Titanium Niobium Nitride (TiNbN) to the entire surface of the above listed components.

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.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a 510(k) summary for a medical device (knee replacement systems) and it explicitly states on page 6, "There was no clinical performance testing required for this device."

This means that the device did not undergo a study to prove it meets clinical acceptance criteria, as per the FDA's determination for this specific 510(k) submission. The FDA found the device to be substantially equivalent to previously cleared predicate devices based on non-clinical performance data and material changes.

Therefore, I cannot provide information for the following sections of your request because they are not present in the document:

1. A table of acceptance criteria and the reported device performance: No clinical acceptance criteria or reported clinical performance is provided. The non-clinical data is summarized, but that's not what you're asking for in terms of "device performance" in a clinical context.
2. Sample sizes used for the test set and data provenance: No clinical test set data.
3. Number of experts used to establish ground truth: No clinical ground truth established.
4. Adjudication method for the test set: No clinical test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such clinical study was done.
6. Standalone performance: Not applicable for a device that did not undergo clinical performance testing in this submission.
7. Type of ground truth used: Not applicable, as there was no clinical testing requiring ground truth establishment.
8. Sample size for the training set: Not applicable for clinical data.
9. How the ground truth for the training set was established: Not applicable for clinical data.

The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicates, not on proving new clinical performance criteria.

Ask a specific question about this device