(88 days)
Not Found
No
The device description and performance studies focus on mechanical properties and structural integrity, with no mention of AI or ML.
Yes
The device is an implant for total knee arthroplasty, which is a medical procedure aimed at treating conditions like severe degeneration or trauma of the knee joint. This constitutes a therapeutic intervention.
No
Explanation: The device is an implantable orthopedic device (tibial cones) used in total knee arthroplasty to address bony defects and provide stability, not to diagnose a medical condition.
No
The device description clearly states it is a physical implant manufactured from Trabecular Metal, porous tantalum, and titanium alloy, intended for surgical implantation in the knee joint. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in total knee arthroplasty, addressing severe degeneration, trauma, or other pathology of the knee joint. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a physical implant made of porous tantalum and titanium alloy, designed to be mechanically attached to a tibial baseplate. This is a medical device intended for implantation, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
- Measuring biomarkers or other indicators of disease
The device described is a surgical implant used to reconstruct the proximal tibia during knee replacement surgery. This falls under the category of a medical device, specifically a surgical implant, not an IVD.
N/A
Intended Use / 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.
Product codes
MBH, JWH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint / proximal tibia
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K102896, K031962, K053340, K024161, K040487
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary
JUN 2 9 2012
| Submitter: | Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Road
Parsippany, New Jersey 07054 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Judith Rosen
Senior Regulatory Affairs Specialist
Telephone: (973) 576-0032 ext 28138
Fax: (973) 884-8792 |
| Date: | March 30, 2012 |
| Trade Name: | NexGen® LCCK Trabecular Metal™ Coupled Tibial
Cones™ |
| 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-coated
uncemented 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.
1
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.
2
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
3
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
4
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