LINK TrabecuLink Femoral Cones

K201364 · Waldemar Link GmbH & Co. KG · MBH · Jul 17, 2020 · Orthopedic

Device Facts

• Record ID: K201364
• Device Name: LINK TrabecuLink Femoral Cones
• Applicant: Waldemar Link GmbH & Co. KG
• Product Code: MBH · Orthopedic
• Decision Date: Jul 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LINK TrabecuLink Femoral and 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 Femoral and 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 Story

LINK TrabecuLink Femoral Cones are orthopedic implants designed to fill large bone defects and stabilize femoral bone structure during total knee replacement. Used in conjunction with LINK Endo-Model Knee System femoral components; the device provides cementless fixation to the bone, while the mating knee endoprosthesis is cemented to the cone. Implants are manufactured via Electron Beam Melting (EBM) of titanium alloy powder (Ti6Al4V), featuring a non-porous bulk interior and a trabecular titanium external surface. Intended for use by orthopedic surgeons in clinical settings. The device benefits patients by restoring structural integrity to the femur in cases of severe bone loss or degeneration, facilitating successful total knee arthroplasty.

Clinical Evidence

No clinical performance testing was required. Substantial equivalence is supported by non-clinical bench testing, including compression testing, dynamic fatigue testing, and coating characterization (porosity, pore size, thickness, static tensile, static/dynamic shear, abrasion, and pyrogenicity testing).

Technological Characteristics

Material: Titanium alloy (Ti6Al4V). Manufacturing: Electron Beam Melting (EBM). Structure: Non-porous bulk interior with trabecular titanium external surface. Fixation: Uncemented to bone, cemented to prosthesis. Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients with severe joint diseases (degenerative, rheumatoid, post-traumatic arthrosis/arthritis) or joint fractures precluding osteosynthetic reconstruction, requiring total knee endoprosthesis due to severe degeneration, bone loss, or trauma.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• NexGen® Trabecular Metal™ Femoral Cone Augments (K103517)
• LINK® TrabecuLink® Tibial Cones (K200113)

Reference Devices

• NexGen® Trabecular Metal™ Tibial Cone Augments (K102896)

Submission Summary (Full Text)

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July 17, 2020

Waldemar Link GmbH & Co. KG % Terry Powell Regulatory Affairs LinkBio Corp. 69 King Street Dover, New Jersey 07801

Re: K201364

Trade/Device Name: LINK® TrabecuLink® Femoral 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: May 22, 2020 Received: May 22, 2020

Dear Terry Powell:

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.

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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 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 (OS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] 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) K201364

Device Name LINK TrabecuLink Femoral Cones

Indications for Use (Describe)

The LINK TrabecuLink Femoral and 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 Femoral and 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

| 510(k)<br>Submitter: | Waldemar Link GmbH & Co. KG<br>Barkhausenweg 10<br>22339 Hamburg, Germany<br>Phone: [phone]<br>Facility Registration:3003386935 (Oststraße 4-10) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Person: | Waldemar Link GmbH & Co. KG<br>Stefanie Fuchs (Regulatory Affairs)<br>Oststraße 4-10<br>22844 Norderstedt, Germany<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Date<br>Prepared: | May 18, 2020 |
| Trade Name: | LINK® TrabecuLink® Femoral Cones |
| Common<br>Name: | Knee System Femoral Cones Augments |
| Classification<br>Name: | Knee joint patellofemorotibial metal/polymer porous-coated<br>uncemented prosthesis; 21 CFR §888.3565, product code MBH |
| Classification<br>and Panel: | Class II, Orthopedic / 87 |
| Predicate<br>Devices: | NexGen® Trabecular Metal™ Femoral Cone Augments (K103517)<br>[primary]; LINK® TrabecuLink® Tibial Cones (K200113) |
| Reference<br>Devices: | NexGen® Trabecular Metal™ Tibial Cone Augments (K102896) |
| Device<br>Description: | The LINK® TrabecuLink® Femoral Cones are an extension to the<br>LINK® TrabecuLink® Tibial Cones (K200113). The femoral cones are<br>designed to be used in conjunction with the LINK® Endo-Model®<br>Knee System Standard / Modular / Porex® coated (K143179;<br>K152431) and with the Endo-Model® SL® Knee System (K151008)<br>femoral components. The subject device is intended to fill large<br>bone defects and stabilize the femoral bone structure in a joint<br>replacement.<br>The femoral cones are manufactured using an EBM (Electron Beam<br>Melting) process with titanium alloy powder (Ti6AI4V). The femoral<br>cones consist of a non-porous bulk interior surface and a trabecular<br>structure made of titanium (LINK® TrabecuLink®) on the external<br>surface. |

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The LINK® TrabecuLink® Femoral Cones provide cementless fixation to the bone. The mating knee endoprosthesis is cemented to the femoral cone.

The LINK® TrabecuLink® Tibial and Femoral Cones are indicated for Indications for Use: 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 and Femoral 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® Femoral Cones are substantially Comparison equivalent to the NexGen® Trabecular Metal™ Femoral Cone to Predicate Device: Augments (K103517). Both are manufactured from porous materials that are intended to fill defects in the femur during total knee replacement. The devices differ in regards to microstructure. materials and manufacturing methods, but these differences do not raise different safety or effectiveness concerns and have been via biocompatibility assessment. addressed non-clinical performance testing, and process validation. The microstructure of the porous regions has been characterized and assessed per coating testing. Further, the subject LINK® TrabecuLink® Femoral Cones are manufactured by the same process and material and have the same porous TrabecuLink surface as the predicate LINK® TrabecuLink® Tibial Cones (K200113).
Features comparable to the predicate devices include the same or similar 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, the following tests were performed:

- Compression testing
- . Dynamic fatique testing

The following testing also applicable to the subject femoral cones was incorporated by reference to the predicate LINK® TrabecuLink® Tibial Cones submission K200113:

- Coating characterization included porosity, pore size, ● thickness measurements
- . Static tensile testing of the porous material

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- Static and dynamic shear testing of the porous material .
- Abrasion testing of the porous material ●
- o Pyrogenicity Testing

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

## Clinical Performance and Conclusions:

There was no clinical performance testing required for this device.

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