(56 days)
No
The summary describes a physical implantable device (femoral and tibial cones) made of titanium alloy with a specific structure for bone fixation. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies focus on mechanical and material properties.
Yes.
The device is indicated for patients with severe joint diseases, aiming to restore mobility and fill bone defects, which are therapeutic functions.
No.
The device is described as an implantable cone used for knee replacement surgeries to fill bone defects and stabilize bone structure. Its intended use focuses on treatment (implant) rather than diagnosis.
No
The device description clearly states the device is a physical implant manufactured using an EBM process with titanium alloy powder, consisting of a non-porous bulk interior and a trabecular structure on the external surface. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the LINK TrabecuLink Femoral and Tibial Cones are implants designed to fill bone defects and stabilize the femoral and tibial bone structure during knee replacement surgery. They are physical components implanted into the body.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status. Its function is purely structural and supportive within the surgical procedure.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes
MBH
Device Description
The LINK® TrabecuLink® Femoral Cones are an extension to the LINK® TrabecuLink® Tibial Cones (K200113). The femoral 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) femoral components. The subject device is intended to fill large bone defects and stabilize the femoral bone structure in a joint replacement. The femoral cones are manufactured using an EBM (Electron Beam Melting) process with titanium alloy powder (Ti6AI4V). The femoral 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® Femoral Cones provide cementless fixation to the bone. The mating knee endoprosthesis is cemented to the femoral cone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Femoral bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions:
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
- 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 devices.
Clinical Performance and Conclusions:
There was no clinical performance testing required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there 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.
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.
1
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 (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) 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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3
510(k) Summary
| 510(k)
Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-539950
Facility Registration:3003386935 (Oststraße 4-10) |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Waldemar Link GmbH & Co. KG
Stefanie Fuchs (Regulatory Affairs)
Oststraße 4-10
22844 Norderstedt, Germany
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-Mail: st.fuchs@linkhh.de |
| Date
Prepared: | May 18, 2020 |
| Trade Name: | LINK® TrabecuLink® Femoral Cones |
| Common
Name: | Knee System Femoral Cones Augments |
| Classification
Name: | Knee joint patellofemorotibial metal/polymer porous-coated
uncemented prosthesis; 21 CFR §888.3565, product code MBH |
| Classification
and Panel: | Class II, Orthopedic / 87 |
| Predicate
Devices: | NexGen® Trabecular Metal™ Femoral Cone Augments (K103517)
[primary]; LINK® TrabecuLink® Tibial Cones (K200113) |
| Reference
Devices: | NexGen® Trabecular Metal™ Tibial Cone Augments (K102896) |
| Device
Description: | The LINK® TrabecuLink® Femoral Cones are an extension to the
LINK® TrabecuLink® Tibial Cones (K200113). The femoral 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)
femoral components. The subject device is intended to fill large
bone defects and stabilize the femoral bone structure in a joint
replacement.
The femoral cones are manufactured using an EBM (Electron Beam
Melting) process with titanium alloy powder (Ti6AI4V). The femoral
cones consist of a non-porous bulk interior surface and a trabecular
structure made of titanium (LINK® TrabecuLink®) on the external
surface. |
4
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
5
- 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.