(173 days)
No
The summary describes a mechanical knee prosthesis and its performance testing, with no mention of AI or ML technologies.
Yes
The device is a total knee system intended to replace diseased or damaged knee joint components, which directly addresses medical conditions and aims to restore function, meeting the definition of a therapeutic device.
No
Explanation: The provided text describes a total knee system, which is a medical implant used to replace a damaged knee joint. Its intended use is for treating conditions like arthritis, avascular necrosis, and deformities, and it is described as a "knee prosthesis." This device is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "semi-constrained, patellofemorotibial, cemented knee prosthesis" and is made of materials like CoCrMo. This indicates a physical implant, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant designed to replace parts of the knee joint in patients with specific conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical prosthesis made of materials like CoCrMo, intended for implantation. This is consistent with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is an in vivo (within the body) surgical implant.
N/A
Intended Use / Indications for Use
The LINK® GEMINI® SL® Total Knee System is indicated for patients suffering from disability due to:
- Degenerative, post-traumatic or rheumatoid arthritis;
- Avascular necrosis of the femoral condyle;
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
- Moderate valgus, varus or flexion deformities.
This device may also be indicated in the salvage of previously failed surgical attempts. The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use.
Product codes
JWH
Device Description
The LINK® GEMINI® SL® Total Knee System is a semi-constrained, patellofemorotibial, cemented knee prosthesis. It is intended to replace the three articular portions of the knee joint. The system compromises two different designs: “Cruciate Retaining (CR) tibial components are made of CoCrMo and are available with PorEx® (K152431) surface modification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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 testing included: Tibial Baseplate Component fatigue test per ISO 14879 and ASTM F1800; Tibial Bearing Component wear test per ISO 14243-1 and -2; Particle Analyses test per ISO 17853 and ASTM F1877; Fretting Corrosion Testing per ASTM F1875-98; Tibial Post Fatigue Testing, Constraint and Range of Motion Analyses. The results of non-clinical performance testing demonstrate that the device is as safe, as effective, and substantially equivalent to the predicate 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
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
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April 3, 2019
Waldemar Link GmbH & Co. KG Andre von Malotki Regulatory Affairs Oststraße 4-10 22844 Norderstedt, Germany
Re: K182872
Trade/Device Name: LINK® GEMINI® SL® Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 1, 2019 Received: March 4, 2019
Dear Andre 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. 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
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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Peter G. Allen -S. The date of the signature is 2019.04.03. The time of the signature is 23:55:12 -04'00'.
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
LINK® GEMINI® SL® Total Knee System
Indications for Use (Describe)
The LINK® GEMINI® SL® Total Knee System is indicated for patients suffering from disability due to:
-
Degenerative, post-traumatic or rheumatoid arthritis;
-
Avascular necrosis of the femoral condyle;
-
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
-
Moderate valgus, varus or flexion deformities.
This device may also be indicated in the salvage of previously failed surgical attempts. The device is indicated for cemented use. Only cementless labeled modular stems are indicated 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)
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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
André von Malotki (Regulatory Affairs)
Oststraße 4-10
22844 Norderstedt, Germany
Phone: +49-40 53995-530
Fax: +49-40 53995-174
E-Mail: a.vonmalotki@linkhh.de |
| Date
Prepared: | December 28th, 2018 |
| Trade Name: | LINK® GEMINI® SL® Total Knee System |
| Common
Name: | Total Knee Prosthesis |
| Classification
Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-
constrained cemented prosthesis; 21 CFR §888.3560, product code
JWH |
| Classification
and Panel: | Class II, Orthopedic / 87 |
| Predicate
Devices: | Foundation® Knee System, manufactured by DJO surgical,
K923277, cleared 02/09/1993 |
| | Foundation® Posterior Stabilized Knee, manufactured by DJO
surgical, K933539, cleared 11/08/1994 |
| | Foundation® Knee System with TiNbN Coating, manufactured by
DJO surgical, K122239, cleared 04/11/2013 |
| Device
Description: | The LINK® GEMINI® SL® Total Knee System is a semi-constrained,
patellofemorotibial, cemented knee prosthesis. It is intended to
replace the three articular portions of the knee joint.
The system compromises two different designs: “Cruciate Retaining
(CR) |
4
tibial components are made of CoCrMo and are available with PorEx® (K152431) surface modification.
The LINK® GEMINI® SL® Total Knee System is indicated for Indications for Use: patients suffering from disability due to:
- I Degenerative, post-traumatic or rheumatoid arthritis:
- Avascular necrosis of the femoral condyle: 트
- I Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy:
- I Moderate valgus, varus or flexion deformities.
This device may also be indicated in the salvage of previously failed surgical attempts.
The device is indicated for cemented use. Only cementless labeled modular stems are indicated for uncemented use.
The LINK® GEMINI® SL® Total Knee System is substantially Comparison equivalent to the commercially available device Foundation® Knee to Predicate Device: System, in that both have same intended use and similar indications, design, materials, technological characteristics, and principles of operation. The minor technological differences between the LINK® GEMINI® SL® Total Knee System and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the LINK® GEMINI® SL® Total Knee System is as safe and effective as the Foundation® Knee System. Both devices are intended for cemented use and contain modular stems for cemented and cementless use. The femoral and tibial components are made of CoCrMo and are available with PorEx® (K152431) surface modification. The predicate device is available with the surface modification AmorCoat™ (K122239) produced by the same manufacturer DOT GmbH with same specifications.
Thus, the LINK® GEMINI® SL® Total Knee System is substantially equivalent.
Performance Non-Clinical Performance and Conclusions:
Non-Clinical performance testing was conducted with consideration Data: to Draft Guidance For The Preparation of Premarket Notifications (510(k)s) for cemented, semi-constrained Total Knee Prostheses, April 1993, Guidance Document for Knee Joint patellofemorotibial femorotibial metal/polymer porous-coated uncemented and Prostheses, January 16, 2003
Non-clinical performance testing included: Tibial Baseplate Component fatigue test per ISO 14879 and ASTM F1800; Tibial Bearing Component wear test per ISO 14243-1 and -2; Particle Analyses test per ISO 17853 and ASTM F1877; Fretting Corrosion Testing per ASTM F1875-98; Tibial Post Fatigue Testing, Constraint
5
and Range of Motion Analyses.
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® GEMINI® SL® Total Knee System is Conclusion: substantially equivalent to the predicate devices identified in this premarket notification.