(133 days)
No
The 510(k) summary describes a modular orthopedic prosthesis system and its components, focusing on materials, intended use for limb salvage/oncology and revision procedures, and non-clinical performance testing related to mechanical properties and wear. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities that would suggest the use of AI/ML.
Yes
Explanation: The device is indicated for the treatment of various medical conditions, including limb salvage/oncology procedures, severe trauma, bone necroses, and revision surgeries, which are all therapeutic interventions.
No
The device is described as a system of components for knee and hip replacement, indicating it is an orthopedic implant for treatment, not diagnosis.
No
The device description explicitly states it is comprised of physical components made of materials like Cobalt Chromium Molybdenum, UHMWPE, and Titanium-Aluminum-Vanadium alloy, and the performance testing involves mechanical fatigue and wear tests, indicating it is a hardware device.
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 for limb salvage/oncology procedures involving bone replacement in the knee and hip areas. This is a therapeutic device used in vivo (within the body).
- Device Description: The device is described as a system of components made of materials like Cobalt Chromium Molybdenum and Titanium-Aluminum-Vanadium alloy, designed for bone replacement. This aligns with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- No mention of diagnostic testing: The text does not mention any use of the device for analyzing samples (like blood, urine, or tissue) to diagnose a condition.
- Performance Studies: The performance studies described are related to the mechanical properties and durability of the implant (fatigue testing, wear testing), which are relevant for surgical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The LINK® MEGASYSTEM-C® is intended to be used with the components of the Endo-Model® SL® Rotating and Non-Rotating Hinge Knee or Endo-Model® Knee System (#K143179) which can be integrated for knee joint replacement and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement.
The LINK® MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures:
-
Revision for loosened femoral prosthesis components involving extensive bone loss;
-
Surgical intervention for severe trauma;
-
Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;
The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.
For the use of the LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge Knee System additional indications should be noted:
-
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, representing the department's focus on health and human well-being. The profiles are depicted in a simple, abstract manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Waldemar Link GmbH & Company KG Ms. Stefanie Reimers Regulatory Affairs Barkhausenweg 10 22339 Hamburg Germany
August 26, 2015
Re: K151008
Trade/Device Name: Link® Megasystem-C® Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO, LZO, JDI, LWJ Dated: July 23, 2015 Received: July 24, 2015
Dear Ms. Reimers:
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. 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 801); medical device reporting of medical device-related
1
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration
Indications for Use
510(k) Number (if known)
Device Name
LINK® MEGASYSTEM-C®
Indications for Use (Describe)
The LINK® MEGASYSTEM-C® is intended to be used with the components of the Endo-Model® SL® Rotating and Non-Rotating Hinge Knee or Endo-Model® Knee System (#K143179) which can be integrated for knee joint replacement and with the MP® Reconstruction Prosthesis (#K142187) for hip replacement.
The LINK® MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures:
-
Revision for loosened femoral prosthesis components involving extensive bone loss;
-
Surgical intervention for severe trauma;
-
- Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;
The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.
- Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;
For the use of the LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge Knee System additional indications should be noted:
- 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 The LINK® MEGASYSTEM-C® is indicated for treatment of any of the following Limb salvage/Oncology procedures:
-
- Revision for loosened femoral prosthesis components involving extensive bone loss;
-
- Surgical intervention for severe trauma;
-
- Oncology cases where extensive resection and replacement of bone is required from tibia to hip area;
The device is to be used with bone cement unless a proximal femur or a modular stem is indicated for use.
For the use of the LINK® Endo-Model® SL® Rotating and Non-Rotating Hinge Knee System additional indications should be noted:
Indications for Use:
7
-
- Bone necroses.
-
- Bicondylar arthrosis by partly damaged collateral ligaments.
- Revision after primary total knee replacement. 3)
- Revision surgery after hinge knee or rotational knee 4) ioint.
-
- Revision surgery by insufficient / inadequate bone mass.
- Arthrosis of patella flange. 6)
- Valgus/Varus deformities