(88 days)
The Trabecular Metal LCCK Coupled Tibial Cones are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Coupled Tibial Cones are for cementless or cemented use.
The NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ are manufactured of Trabecular Metal™, porous tantalum with titanium alloy screws and screw inserts. The proposed TM Coupled Tibial Cones intend to combine the function of TM Tibial Augments and TM Tibial Cone Augments. The TM Coupled Tibial Cone design uses the same cavitary filling geometries of the TM Tibial Cone Augment and the mating functions of the TM Tibial Augment to specifically address small to medium segmented, contained, cavitary bony defects of the proximal tibia found during revision surgery. The TM Coupled Tibial Cone design provides the use of mechanical attachment to the tibial baseplate to allow for modularity and intra-operative assembly. The design is intended to provide stability to the tibial baseplate construct after reconstruction of the proximal tibia when subjected to normal gait activities.
The provided document, K120990, describes a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies with human participants. Therefore, many of the requested data points related to human reader studies, training sets, and expert ground truth are not applicable in this context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance for normal gait activities (walking, stair ascent/decent, deep flexion) for the proposed implant needs to meet predetermined requirements. | A comparative Finite Element Analysis (FEA) study was performed to evaluate the strength of the proposed TM Coupled Tibial Cone designs across different normal gait activities (walking, stair ascent/decent and deep flexion). The results demonstrated that the proposed implant adequately meets the predetermined requirements established for its mechanical performance. This supports its substantial equivalence to the predicate devices. The submission states there are "no significant differences between the proposed NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ and the predicates currently being marketed. Any differences in technological characteristics do not raise new issues of safety and efficacy." |
| Substantial equivalence to predicate devices regarding materials, intended use, indications for use, technological characteristics, and design features. | The NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ have the same material, intended use, and indications for use as the previously cleared predicate devices (Zimmer's NexGen® Trabecular Metal™ Tibial Cone Augments (K102896, K031962, K053340) and Zimmer's NexGen® Complete Knee Solution - Trabecular Metal™ Augments (K024161, K040487)). This submission introduces a version of the cone augments to address a wider range of defects, but incorporates the same technological characteristics and design features as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The study referenced is a Finite Element Analysis (FEA), which is a computational simulation. Therefore, there isn't a "sample size" in the traditional sense of patient data. The "test set" would be the conditions and parameters used in the FEA model. The document does not specify the number of simulations or variations performed within the FEA.
- Data Provenance: Not applicable in the context of an FEA study comparing mechanical performance to a predicate device. This is a design and engineering analysis, not based on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable: For an FEA study evaluating mechanical performance, "ground truth" is established through engineering principles, material properties, and validated simulation methods, not by expert human review of images or clinical data. The "experts" would be the engineers and biomechanical analysts who designed and validated the FEA model.
4. Adjudication Method for the Test Set:
- Not Applicable: Since this is an FEA study, there is no adjudication method in the context of human interpretation of results. The output of the FEA is numerical and visual data representing stress, strain, and deformation, which is then interpreted against predetermined engineering criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:
- No: An MRMC comparative effectiveness study was not performed. This type of study is typically conducted for diagnostic or screening devices where human reader performance is a critical outcome. The K120990 submission focuses on the mechanical substantial equivalence of an orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done:
- Yes, in the context of mechanical engineering: The Finite Element Analysis (FEA) can be considered a "standalone" or "algorithm only" study in that it computationally models the device's behavior under various loads without human interpretation of clinical images or data being part of the primary assessment. The FEA algorithm calculates stress and strain, and these calculations are then reviewed by engineers.
7. The Type of Ground Truth Used:
- Engineering Principles and Predicate Device Performance: The "ground truth" for the FEA study is based on established biomechanical engineering principles, material properties of the device and surrounding bone, and the known acceptable mechanical performance of the predicate devices under similar loading conditions (normal gait activities). The FEA models the real-world mechanical behavior of the device.
8. The Sample Size for the Training Set:
- Not Applicable: The FEA study does not involve a "training set" in the context of machine learning. The FEA model is built based on design specifications, material properties, and biomechanical principles.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no training set in the machine learning sense, this question is not relevant to the K120990 submission. The parameters and assumptions of the FEA model are based on established engineering practices and validated material data.
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510(k) Summary
JUN 2 9 2012
| Submitter: | Zimmer Trabecular Metal Technology, Inc.10 Pomeroy RoadParsippany, New Jersey 07054 |
|---|---|
| Contact Person: | Judith RosenSenior Regulatory Affairs SpecialistTelephone: (973) 576-0032 ext 28138Fax: (973) 884-8792 |
| Date: | March 30, 2012 |
| Trade Name: | NexGen® LCCK Trabecular Metal™ Coupled TibialCones™ |
| Common Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented and uncemented |
| Classification Name: | "Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis";and"Knee joint patellofemorotibial metal/polymer porous-coateduncemented prosthesis" |
| Reference: | 21 CFR § 888.3560, JWH and 21 CFR § 888.3565, MBH |
DEVICE DESCRIPTION
The NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ are manufactured of Trabecular Metal™, porous tantalum with titanium alloy screws and screw inserts. The proposed TM Coupled Tibial Cones intend to combine the function of TM Tibial Augments and TM Tibial Cone Augments. The TM Coupled Tibial Cone design uses the same cavitary filling geometries of the TM Tibial Cone Augment and the mating functions of the TM Tibial Augment to specifically address small to medium segmented, contained, cavitary bony defects of the proximal tibia found during revision surgery. The TM Coupled Tibial Cone design provides the use of mechanical attachment to the tibial baseplate to allow for modularity and intra-operative assembly. The design is intended to provide stability to the tibial baseplate construct after reconstruction of the proximal tibia when subjected to normal gait activities.
INDICATIONS FOR USE
The Trabecular Metal LCCK Coupled Tibial Cones are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Coupled Tibial Cones are for cementless or cemented use.
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DEVICE TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICES
The NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ were shown to be substantially equivalent to the legally marketed predicate devices. These predicates include Zimmer's NexGen® Trabecular Metal™ Tibial Cone Augments (K102896, K031962, K053340), and Zimmer's NexGen® Complete Knee Solution - Trabecular Metal™ Augments (K024161, K040487).
The NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ have the same material as the previously cleared predicate devices. The intended use and indications for use of the subject devices are the same as that of the predicate devices. This Traditional Premarket Notification 510(k) submission is to introduce a version of the cone augments to address a wider range of defects. This configuration incorporates the same technological characteristics and design features as the predicate devices.
There are no significant differences between the proposed NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ and the predicates currently being marketed. Any differences in technological characteristics do not raise new issues of safety and efficacy.
PERFORMANCE DATA
A comparative Finite Element Analysis (FEA) study was performed to evaluate the strength of the proposed TM Coupled Tibial Cone designs across different normal gait activities (walking, stair ascent/decent and deep flexion). The results of testing and analysis conducted demonstrate that the proposed implant adequately meets the predetermined requirements established for its mechanical performance, supporting substantial equivalence to the predicate.
CONCLUSION
The NexGen® LCCK Trabecular Metal™ Coupled Tibial Cones™ are the same as the predicate device with respect to intended use/indications for use, technological characteristics and basic principles of operation. This product does not present any new issues of safety or effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Zimmer Trabecular Metal Technology % Ms. Judith Rosen Senior Regulatory Affairs Specialist 10 Pomeroy Road Parsippany, New Jersey 07054
Re: K120990
Trade/Device Name: NexGen® LCCK Trabecular Metal™ Couples Tibial Regulation Number: CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH, JWH Dated: March 30, 2012 Received: April 02, 2012
JUN 2 9 2012
Dear Ms. Rosen:
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
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Page 2 – Ms. Judith Rosen
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
60
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ V120990
Device Name: NexGen® Trabecular Metal™ LCCK Coupled Tibial Cones™
Indications for Use:
The Trabecular Metal LCCK Coupled Tibial Cones are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty. When used with the NexGen Complete Knee Solution - Legacy Constrained Condylar Knee System, the Trabecular Metal Coupled Tibial Cones are for cementless or cemented use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
K120990
510(k) Number
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.