(30 days)
Not Found
No
The summary describes a mechanical knee implant and does not mention any software, algorithms, or AI/ML terms.
Yes
The device is a knee implant used for total knee arthroplasty, which is a surgical procedure to treat severe degeneration, trauma, or pathology of the knee joint. This directly addresses and treats a medical condition, qualifying it as a therapeutic device.
No
Explanation: The device is a knee implant used for total knee arthroplasty, which is a treatment for severe degeneration, trauma, or other pathology of the knee joint. It does not perform any diagnostic function.
No
The device description explicitly states it is manufactured from physical materials (Trabecular Metal and UHMWPE), indicating it is a hardware device, not software-only.
Based on the provided information, the NexGen® TMT Tibia is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for replacing a knee joint due to degeneration, trauma, or other pathology. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a knee implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The device is used in the knee joint, not for analyzing samples from the knee joint.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NexGen® TMT Tibia is a medical device used for surgical reconstruction.
N/A
Intended Use / Indications for Use
The NexGen TMT Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
Product codes
JWH
Device Description
The NexGen TMT Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE). These tibial components are intended for use with Zimmer NexGen CR Femoral Components.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Implex Corp.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The NexGen TMT Tibia Submitter Name: Implex Corp. Submitter Address: 80 Commerce Drive Allendale, New Jersey 07401-1600 Robert A. Poggie, Ph.D. Contact Person: (201) 818-1800 Phone Number: Fax Number: (201) 995-9722 August 2, 2001 Date Prepared: The NexGen TMT Tibia Device Trade Name: Device Common Articular Surface and Tibial Components Name: Classification Number 21 CFR § 888.3560 and Name: Substantial The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of Equivalence: substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws
- Device Description: The NexGen TMT Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE).
or their application by the courts.
These tibial components are intended for use with Zimmer NexGen CR Femoral Components.
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510(k) Summary (Continued)
The NexGen TMT Tibia is intended for use where severe Indications for Use: degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
The NexGen TMT Tibia is substantially equivalent to the Conclusion: identified predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2001
Dr. Robert A. Poggie Director of Applied Research Implex Corp. 80 Commerce Drive. Allendale, New Jersey 07401
Re: K012866
Trade/Device Name: The NEXGEN® TMT Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Regulatory Class: II
Product Code: JWH Dated: August 24, 2001 Received: August 27, 2001
Dear Dr. Poggie:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); 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.
3
Page 2 - Dr. Robert A. Poggie
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21-CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Mark A. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NexGen® TMT Tibia Special 510(k) Premarket Notification
510(k) Number (if known) :
012866
Device Name:
The NexGen® TMT Tibia
Indications For Use:
NexGen® TMT Tibia is intended for use where severe The degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
Mark n Melkerson
(Division eral, Restorative Division levices and Neu
510(k) N
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR . . .
Over-The-Counter Use
(Optional Format 1-2-96)