(22 days)
Not Found
No
The document describes a knee implant system and its components, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is a knee system, and its intended use is to treat various knee conditions such as degenerative, rheumatoid, or post-traumatic arthrosis or arthritis, bone necroses, and deformities, which are all therapeutic interventions designed to alleviate suffering, repair damage, or prolong life.
No
The device is a knee system (Knee System adds Femoral Segments (Augments) made of UHMWPE) used for treatment/replacement of the knee joint. It is not used for diagnosing medical conditions.
No
The device description clearly states that the device is comprised of physical components (Femoral Segments made of UHMWPE) and does not mention any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly indicate that the LINK Endo-Model Knee System is a surgical implant designed to replace or augment parts of the knee joint in patients with various knee conditions. It is a physical device implanted into the body, not a test performed on a sample outside the body.
The text focuses on the surgical application, materials (UHMWPE), and anatomical site (knee joint), all of which are characteristic of a surgical implant rather than an IVD.
N/A
Intended Use / Indications for Use
The LINK Endo-Model Knee System is indicated for patients with diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. This device is intended for cemented use only unless a cementless modular stem is indicated for use. The LINK Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System are indicated for the following conditions:
- Bone necroses.
- Bicondylar arthrosis by partly damaged collateral ligaments
- Revision after primary total knee replacement.
- Revision surgery after hinge knee or rotational knee joint.
- Revision surgery by insufficient / inadequate bone mass.
- Arthrosis of patella flange.
- Valgus/Varus deformities
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
June 30, 2021
Waldemar Link GmbH & Co. KG % Terry Powell Regulatory Affairs Program Director LinkBio Corp. 69 King Street Dover, New Jersey 07801
Re: K211768
Trade/Device Name: LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: June 8, 2021 Received: June 8, 2021
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.
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
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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 (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 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. 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) K211768
Device Name
The LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
Indications for Use (Describe)
The LINK Endo-Model Knee System is indicated for patients with diseases with limitation of mobility due to degenerative, rheumatoid or post-traumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. This device is intended for cemented use only unless a cementless modular stem is indicated for use. The LINK Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System are indicated for the following conditions:
- Bone necroses.
-
- Bicondylar arthrosis by partly damaged collateral ligaments
-
- Revision after primary total knee replacement.
-
- Revision surgery after hinge knee or rotational knee joint.
-
- Revision surgery by insufficient / inadequate bone mass.
- Arthrosis of patella flange.
-
- Valgus/Varus deformities Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
| 510(k)
Submitter: | Waldemar Link GmbH & Co. KG
Barkhausenweg 10
22339 Hamburg, Germany
Phone: +49-40-53995 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Facility Registration: 3004371426 |
| Date Prepared: | June 4, 2021 |
| Trade Name: | LINK Endo-Model Total Knee System, Femoral Segments (Augments), UHMWPE |
| Common Name: | Artificial knee replacement system |
| Classification
Name: | 21 CFR §888.3510: Knee joint femorotibial metal/polymer constrained cemented
prosthesis |
| Classification
and Panel: | Class II, Orthopedic / 87, KRO |
| Predicate
Devices: | K143179: LINK Endo-Model Knee System by Waldemar Link GmbH & Co KG
[Primary predicate]
K151008, LINK Megasystem-C with Endo-Model SL Knee System, by
Waldemar Link GmbH & Co KG
K821476/S01: LINK Endo-Model Rotating Hinge Revision Knee System by
Waldemar Link GmbH & Co KG, (original submission by CR Bard). |
| Reason for
Submission | The submission adds the following accessory components: Femoral Segments
(Augments) made of UHMWPE. |
| Device
Description: | This 510k adds Femoral Segments (Augments) made of UHMWPE. The subject
femoral segments are available in four heights: size 1 (20mm h), size 2 (25mm h),
size 3 (50mm h), and size 4 (80mm h). They are available in right and left versions,
and in sizes x-small, small, medium, and large, which correspond to the femoral
component sizing. The size 1 and size 2 segments are a unicompartmental design
provided either as a set containing one medial and one lateral component, or
individually packaged (e.g. only the medial or only the lateral). The size 3 and 4 are
a bicompartmental design (do not have medial versus lateral components like the
size 1 and 2 variants). |
| Intended Use: | The LINK Endo-Model Knee System is indicated for patients with severe joint
diseases with limitation of mobility due to degenerative, rheumatoid or post-
traumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic
reconstruction. This device is intended for cemented use only unless a cementless
modular stem is indicated for use. |
| | The LINK Endo-Model Rotating Hinge and Modular Rotating Hinge Knee System are indicated for the following conditions:
- Bone necroses.
- Bicondylar arthrosis by partly damaged collateral ligaments
- Revision after primary total knee replacement.
- Revision surgery after hinge knee or rotational knee joint.
- Revision surgery by insufficient / inadequate bone mass.
- Arthrosis of patella flange.
- Valgus/Varus deformities