(257 days)
Not Found
No
The summary describes a mechanical knee prosthesis with a new coating. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a knee replacement system intended for patients with severe joint diseases, fractures, and other conditions that limit mobility, aiming to restore joint function.
No
The device is a knee replacement system intended for the treatment of severe joint diseases and fractures, not for diagnosing conditions.
No
The device description clearly outlines physical components made of materials like Cobalt Chromium Molybdenum casting alloy and UHMWPE, indicating it is a hardware device (knee prosthesis). The change described is a coating applied to these physical components.
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that this device is a knee prosthesis, which is an implantable medical device used to replace a damaged knee joint.
- Intended Use: The intended use describes the conditions for which the knee prosthesis is indicated, all of which relate to severe joint diseases and fractures requiring surgical intervention and implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the LINK® Endo-Model® and Sled Knee Systems with PorEx® (TiNbN) coating are not IVD devices. They are surgical implants.
N/A
Intended Use / Indications for Use
The LINK® Endo-Model® and Sled Knee Systems with PorEx® (TiNbN) coating are 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. These devices are intended for cemented use only.
The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System with PorEx® (TiNbN) coating 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, line-art style.
May 9, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Waldemar Link Gmbh & Company KG Andre Von Malotki Regulatory Affairs Barkhausenweg 10 Hamburg, 22339 GERMANY
Re: K152431
Trade/Device Name: LINK® Endo-Model® Knee System with PorEx® (TiNbN) coating, LINK® Sled Knee System with PorEx® (TiNbN) coating Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO, HSX Dated: April 15, 2016 Received: April 19, 2016
Dear Mr. Von Malotki:
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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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" (21CFR 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 N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152431
Device Name
LINK® Endo-Model® Knee System with PorEx® (TiNbN) coating and LINK® Sled Knee System with PorEx® (TiNbN) coating
Indications for Use (Describe)
The LINK® Endo-Model® and Sled Knee Systems with PorEx® (TiNbN) coating are indicated for patients with severe joint diseases with limitation of mobility due to degenerative, rheumatic arthrosis or arthritis. Joint fractures which disallow an osteosynthetic reconstruction. These devices are intended for cemented use only.
The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System with PorEx® (TiNbN) coating 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 ☑ 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 #:3004371426 (Oststraße 4-10) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Waldemar Link GmbH & Co. KG
Stefanie Reimers (Regulatory Affairs)
Oststraße 4-10
Norderstedt, GERMANY 22844
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-Mail: S.Reimers@linkhh.de |
| Date Prepared: | August 24th, 2015 |
| Trade Name: | LINK® Endo-Model® Knee System with PorEx® (TiNbN)
coating and LINK® Sled Knee System with PorEx® (TiNbN)
coating |
| Common Name: | Total Knee Prosthesis |
| Classification Name: | Knee joint femorotibial metal/polymer constrained cemented
prosthesis; 21 CFR §888.3510, product code KRO |
| | Knee joint femorotibial metal/polymer non-constrained
cemented prosthesis; 21 CFR §888.3520, product code HSX |
| Classification and Panel: | Class II, Orthopedic / 87 |
| Predicate Devices: | Foundation Knee System with TiNbN coating; Foundation PS
Knee System with TiNbN coating; 3D Knee System with
TiNbN coating by DJO Surgical, K122239, cleared April 11,
2013 |
| | LINK® Endo-Model® Knee System, K143179, cleared
January 30, 2015 |
| | LINK® Sled Uni-Compartment Knee System, K954186,
cleared January 26, 1996 |
| Device Description: | The LINK® Endo-Model® Knee System is constrained anti-
luxation total knee prosthesis.
Retaining the low friction principle, the physiological
movement of the rotational knee prosthesis is optimal |
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Flexion and rotation of the rotational knee prosthesis take place in a cross joint.
The LINK® Endo-Model® Knee System consists of femoral and tibial components and modular stems. The modular stems are available in a variety of diameters and lengths in cemented version.
The LINK® Endo-Model® Knee System is available in two (2) different knee joint versions:
- -Rotating Hinge Knee - Standard (Non-Modular) Version
- Rotating Hinge Knee Modular Version -
The LINK® Endo-Model® Knee System is produced of Cobalt Chromium Molybdenum casting alloy (CoCrMo) and Ultra high molecular weight polyethylene (UHMWPE / noncrosslinked). The modular stems (cemented) are made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) materials.
The LINK® Sled Knee is a unicompartmental nonconstrained knee replacement system. The LINK® Sled Knee is comprised of a set of implants and consists of a femoral component and a tibial component (all-polyethylene or metalbacked) and are available in different sizes.
The femoral implant is made of Cobalt Chromium Molybdenum casting alloy (CoCrMo) and is personalized to match a patient's anatomy.
The all poly tibial component is made from Ultra high molecular weight polyethylene (UHMWPE / nonand forgeable and cold-formed cobaltcrosslinked) chromium-nickel molybdenum-iron alloy (CoCrNiMoFe) Xray wire. The metal-backed tibial component consists of a Cobalt Chromium Molybdenum casting alloy (CoCrMo) tibial tray and with an Ultra high molecular weight polyethylene (UHMWPE / non-crosslinked) tibial insert and cold-formed cobalt-chromium-nickel molybdenum-iron alloy (CoCrNiMoFe) X-ray wire.
Multiple inserts of varying thickness may be provided to accommodate surgeon preferences.
The change that is the subject of this 510(k) is to add the coating of Titanium Niobium Nitride (TiNbN) to the entire surface of the above listed components.
There is no change to the fundamental scientific technology of the referenced knee systems with the modifications in this
5
510(k) submission. This includes no changes to materials, design, sterilization, packaging, or method of manufactured. All components are sterile and for single use only.
Indications for Use: The LINK® Endo-Model® and Sled Knee Systems with PorEx® (TiNbN) coating are 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. These devices are intended for cemented use only.
The LINK® Endo-Model® Rotating Hinge and Modular Rotating Hinge Knee System with PorEx® (TiNbN) coating 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 4) joint
-
- Revision surgery by insufficient / inadequate bone mass
-
- Arthrosis of patella flange
-
- Valgus/Varus deformities