(61 days)
No
The summary describes a physical implant (tibial cones) made of titanium with a specific structure for bone fixation. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests of the material properties.
Yes.
The device is indicated for patients with severe joint diseases, post-traumatic arthrosis or arthritis, and joint fractures, all of which are conditions that benefit from therapeutic intervention to restore mobility and function. The device itself is an implant used in total knee endoprosthesis after severe degeneration or bone loss.
No
The device description clearly states its purpose is to "fill small to medium bone defects and provide a stable platform for the tibial articulating components" in the context of knee arthroplasty, and it is an implantable medical device, not a diagnostic tool.
No
The device description clearly states the device is a physical implantable component made of titanium alloy, manufactured using an EBM process. It is a hardware device intended to fill bone defects.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to address bone defects in the tibia during knee replacement surgery. This is a therapeutic and structural function within the body.
- Device Description: The device is described as a tibial cone made of titanium alloy, designed to be implanted into bone and provide a platform for other knee replacement components. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on biological samples to provide information about a person's health status. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
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.
Product codes
MBH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, tibia
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
- 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.
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.
0
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
1
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
2
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 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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)
Facility Registration: 3007118403 (Harckesheyde 95) |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | January 15th, 2020 |
| Trade Name: | LINK® TrabecuLink® Tibial Cones |
| Common
Name: | Knee System Tibial 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™ Tibial Cone Augments by Zimmer
Biomet Holdings, Inc., K102896, cleared December 13, 2010
Optetrak Logic® Metaphyseal Cones by Exactech, Inc., K153595,
cleared March 25, 2016 |
| 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. |
| Indications
for Use: | The LINK® TrabecuLink® Tibial Cones are indicated for patients with
severe joint diseases with limitation of mobility due to degenerative. |
4
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.