(173 days)
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.
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.
This document is a 510(k) premarket notification for the LINK® GEMINI® SL® Total Knee System. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria that the device proves to meet in a clinical setting.
Therefore, the information you requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a clinical trial with performance metrics, is largely not applicable in this document. This submission relies on non-clinical performance testing to demonstrate substantial equivalence.
I will address the requested points based on the information provided, explicitly stating when the information is not available or not applicable.
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in the format of pass/fail metrics for a clinical study. Instead, it relies on demonstrating that the device performs comparably to the predicate device through non-clinical testing. The "reported device performance" is the successful completion of these non-clinical tests.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Non-Clinical Testing) |
|---|---|
| Mechanical and material properties comparable to predicate and meeting relevant standards for safety and effectiveness. | Tibial Baseplate Component fatigue test per ISO 14879 and ASTM F1800: Results demonstrate safety, effectiveness, and substantial equivalence to predicate. |
| Tibial Bearing Component wear test per ISO 14243-1 and -2: Results demonstrate safety, effectiveness, and substantial equivalence to predicate. | |
| Particle Analyses test per ISO 17853 and ASTM F1877: Results demonstrate safety, effectiveness, and substantial equivalence to predicate. | |
| Fretting Corrosion Testing per ASTM F1875-98: Results demonstrate safety, effectiveness, and substantial equivalence to predicate. | |
| Tibial Post Fatigue Testing: Results demonstrate safety, effectiveness, and substantial equivalence to predicate. | |
| Constraint and Range of Motion Analyses: Results demonstrate safety, effectiveness, and substantial equivalence to predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "non-clinical performance testing," which typically involves laboratory testing on device components, not human test subjects or retrospective/prospective data from a specific country. Therefore, "sample size for the test set" and "data provenance" as applied to clinical studies are not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as there was no clinical test set requiring expert ground truth. The evaluation was based on non-clinical engineering and materials testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there was no clinical test set or human interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a total knee system, not an AI-assisted diagnostic or imaging device. No MRMC study was mentioned or performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a total knee system, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established scientific and engineering principles and standards (e.g., ISO and ASTM standards) for evaluating the mechanical and material performance of total knee prostheses. The device's performance was compared against these standards and the known performance of the predicate device.
8. The sample size for the training set
This information is not applicable as the document describes a medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
{1}------------------------------------------------
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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"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."
{3}------------------------------------------------
510(k) Summary
| 510(k)Submitter: | Waldemar Link GmbH & Co. KGBarkhausenweg 1022339 Hamburg, GermanyPhone: +49-40-539950Facility Registration:3003386935 (Oststraße 4-10)Facility Registration: 3007118403 (Harckesheyde 95) |
|---|---|
| ContactPerson: | Waldemar Link GmbH & Co. KGAndré von Malotki (Regulatory Affairs)Oststraße 4-1022844 Norderstedt, GermanyPhone: +49-40 53995-530Fax: +49-40 53995-174E-Mail: a.vonmalotki@linkhh.de |
| DatePrepared: | December 28th, 2018 |
| Trade Name: | LINK® GEMINI® SL® Total Knee System |
| CommonName: | Total Knee Prosthesis |
| ClassificationName: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; 21 CFR §888.3560, product codeJWH |
| Classificationand Panel: | Class II, Orthopedic / 87 |
| PredicateDevices: | Foundation® Knee System, manufactured by DJO surgical,K923277, cleared 02/09/1993 |
| Foundation® Posterior Stabilized Knee, manufactured by DJOsurgical, K933539, cleared 11/08/1994 | |
| Foundation® Knee System with TiNbN Coating, manufactured byDJO surgical, K122239, cleared 04/11/2013 | |
| DeviceDescription: | The LINK® GEMINI® SL® Total Knee System is a semi-constrained,patellofemorotibial, cemented knee prosthesis. It is intended toreplace 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.
§ 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.