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.

Device Description

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.

AI/ML Overview

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.

Performance Test Category	Reported Performance (Qualitative)
Non-Clinical Performance Testing
Compression Testing	Results demonstrate substantial equivalence to predicate device.
Coating Characterization (Porosity, Pore Size, Thickness Measurements)	Results demonstrate substantial equivalence to predicate device.
Static Tensile Testing of Porous Material	Results demonstrate substantial equivalence to predicate device.
Static and Dynamic Shear Testing of Porous Material	Results demonstrate substantial equivalence to predicate device.
Abrasion Testing of Porous Material	Results demonstrate substantial equivalence to predicate device.
Pyrogenicity Testing	Results demonstrate substantial equivalence to predicate device.
Clinical Performance	No clinical performance testing required or conducted.

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.

Summary

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March 18, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Waldemar Link GmbH & Co. KG Stefanie Fuchs Offical Correspondent Oststrabe 4-10 Norderstedt. 22844 GERMANY

Re: K200113

Trade/Device Name: LINK TrabecuLink Tibial Cones Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH Dated: January 17, 2020 Received: January 17, 2020

Dear Stefanie Fuchs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200113

Device Name LINK® TrabecuLink® Tibial Cones

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

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510(k) Summary

510(k)Submitter:	Waldemar Link GmbH & Co. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950Facility Registration:3003386935 (Oststraße 4-10)Facility Registration: 3007118403 (Harckesheyde 95)
ContactPerson:	Waldemar Link GmbH & Co. KGStefanie Fuchs (Regulatory Affairs)Oststraße 4-1022844 Norderstedt, GermanyPhone: +49-40 53995-530Fax: +49-40 53995-174E-Mail: st.fuchs@linkhh.de
DatePrepared:	January 15th, 2020
Trade Name:	LINK® TrabecuLink® Tibial Cones
CommonName:	Knee System Tibial Cones Augments
ClassificationName:	Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis; 21 CFR §888.3565, product code MBH
Classificationand Panel:	Class II, Orthopedic / 87
PredicateDevices:	NexGen® Trabecular Metal™ Tibial Cone Augments by ZimmerBiomet Holdings, Inc., K102896, cleared December 13, 2010Optetrak Logic® Metaphyseal Cones by Exactech, Inc., K153595,cleared March 25, 2016
DeviceDescription:	The LINK® TrabecuLink® Tibial Cones are designed to be used inconjunction 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 subjectdevice is intended to fill small to medium bone defects and provide astable platform for the tibial articulating components.The tibial cones are manufactured using an EBM (Electron BeamMelting) process with titanium alloy powder (Ti6Al4V, ISO 5832-3).The tibial cones consist of a non-porous bulk interior surface and atrabecular structure made of titanium (LINK® TrabecuLink®) on theexternal surface.The LINK® TrabecuLink® Tibial Cones provide cementless fixationto the bone. The subsequently implanted knee endoprosthesis iscemented to the tibial cone.
Indicationsfor Use:	The LINK® TrabecuLink® Tibial Cones are indicated for patients withsevere joint diseases with limitation of mobility due to degenerative.

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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 substantially equivalent Comparison to Zimmer® NexGen® Trabecular Metal™ Tibial Cone Augments to Predicate (K102896) and Exactech® Optetrak Logic® Metaphyseal Cones Device: (K153595). Both are manufactured from porous materials that are intended to fill defects in the tibia during total knee replacement. The devices differ in reqards to microstructure, materials and manufacturing methods, but these differences do not raise difference safety or effectiveness concerns and have been addressed via a biocompatibility assessment and process validation. The microstructure of the porous regions has been characterized and assessed per coating testing. Further, the same EBM material has been seen in K153595.

Features comparable to the predicate devices include the same indications, dimensions, materials, surgical implantation technique and intended use.

Performance Non-Clinical Performance and Conclusions: Data: Non-clinical performance testing and analysis were provided, including bench testing and coating characterization. Specifically,

Compression testing
the following tests were performed:
Coating characterization included porosity, pore size, ● thickness measurements
Static tensile testing of the porous material
Static and dynamic shear testing of the porous material
Abrasion testing of the porous material ●
Pyrogenicity Testing

The results of non-clinical performance testing demonstrate that the device is as safe, as effective and substantially equivalent to the predicate device.

Clinical Performance and Conclusions:

There was no clinical performance testing required for this device.

The subject device LINK® TrabecuLink® Tibial Cones are Conclusion: substantially equivalent to the predicate devices identified in this premarket notification.

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.