(90 days)
Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty.
Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty. These devices are of monoblock construct and are manufactured from Trabecular Metal (Hedrocel Porous Tantalum) and direct compression molded ultrahigh molecular weight polyethylene. The Trabecular Metal Tibial and Patellar Components for the NexGen Knee System articulate with the appropriate Zimmer CR and LPS Femoral Components.
The provided text describes a 510(k) summary for medical devices, specifically prosthetic knee components. This type of document is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific performance criteria through a study with acceptance criteria in the way envisioned by the prompt.
Therefore, many of the requested categories (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, training set size) are not applicable to this document as it does not detail a study conducted to establish performance metrics against predefined acceptance criteria for a new, unique device.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance Study (Not Applicable in the traditional sense for this 510(k))
This 510(k) relies on demonstrating substantial equivalence to existing predicate devices. It does not present a new clinical or performance study with acceptance criteria and measured performance in the typical sense of a novel device. The core argument is that the subject device is essentially the same as the predicate and will therefore perform similarly.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Stated | Not Stated |
| (No explicit numerical or qualitative acceptance criteria for clinical performance are presented as this is a substantial equivalence submission, not a de novo device performance study.) | (No specific performance metrics are reported against acceptance criteria. The document states "the device will perform as intended" based on testing per applicable standards, but doesn't quantify this performance against specific thresholds.) |
2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a clinical "test set" for performance evaluation in the context of a new device study. The testing refers to engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth establishment by experts is not described, as this is not a study assessing diagnostic accuracy or similar performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is mentioned, as no clinical test set requiring expert review is described.
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:
Not applicable. This device is a knee implant, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not a software algorithm; it is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Ground truth is not a concept pertinent to this type of substantial equivalence submission for a physical implant. The "truth" in this context is that the device adheres to established material and design standards and is functionally equivalent to already marketed devices.
8. The sample size for the training set:
Not applicable. There is no machine learning or AI component requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no machine learning or AI component, and thus no training set or its associated ground truth establishment.
Summary of Relevant Information from the Document:
- Device Name: Trabecular Metal Tibial and Patellar Components for the NexGen Knee System
- Intended Use: For severe degeneration, trauma, or other pathology of the knee joint indicating cemented or cementless total knee arthroplasty.
- Basis for Equivalence:
- The subject device is described as "identical" to the predicate device in materials, size options, technological design, and geometry features.
- The primary difference is the addition of an "uncemented use" option to the indications for use.
- Performance Data: "The NexGen TMT Tibia, LPS Tibia and Primary Porous Patella were all tested per applicable standards and the results demonstrated that the device will perform as intended." This refers to engineering/bench testing according to standards, not a clinical trial with specific performance criteria.
- Regulatory Conclusion: FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under general controls.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Trabecular Metal Tibial and Patellar Components for the NexGen Knee System
| Submitter Name: | Implex Corp. |
|---|---|
| Submitter Address: | 80 Commerce DriveAllendale, New Jersey 07401-1600 |
| Contact Person(s): | Marci Halevi |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (973) 829-0825 |
| Date Prepared: | May 6, 2003 |
| Device Trade Name: | Trabecular Metal Tibial and Patellar Components for theNexGen Knee System |
| Device Common Name: | Tibial and Patellar Components |
| Classification Name: | Knee Joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis |
| SubstantialEquivalence: | The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantialequivalence found in the Federal Food, Drug andCosmetic Act, as amended and as applied under 21 CFR807, Subpart E under which a device can be marketedwithout premarket approval or reclassification.Adetermination 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 or their application by the courts.
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510(K) Summary of Safety and Effectiveness - Continued...
| Page 2 of | |
|---|---|
| Device Description: | Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty. |
| These devices are of monoblock construct and are manufactured from Trabecular Metal (Hedrocel Porous Tantalum) and direct compression molded ultrahigh molecular weight polyethylene. | |
| The Trabecular Metal Tibial and Patellar Components for the NexGen Knee System articulate with the appropriate Zimmer CR and LPS Femoral Components. | |
| Intended Use: | Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented or cementless total knee arthroplasty. |
| Device TechnologicalCharacteristics andComparison toPredicate Device: | The predicate and subject devices are identical;performance characteristics therefore remain asdocumented in the predicate submissions. |
| Performance Data: | The NexGen TMT Tibia, LPS Tibia and Primary Porous Patella were all tested per applicable standards and the results demonstrated that the device will perform as intended. |
| Conclusion: | The Trabecular Metal Tibial and Patellar Components for the NexGen Knee System incorporates the identical materials, size options, technological design and geometry features as the legally marketed predicate devices described herein. The single difference is in the Indications for Use and associated changes to the Package Insert and Surgical Protocol, which will now incorporate the option for uncemented use. Review of 21.CFR 888.3565, Special Guidance Document for porous coated uncemented prosthesis, and the pre- clinical testing of the predicate (and subject) devices indicate no additional risk or change in safety or efficacy for the indicated and intended uses. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2003
Ms. Marci Halevi Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
Re: K031462 Trade/Device Name: Trabecular Metal Tibial and Patellar Components for the NexGen Knee System Regulation Numbers: 21 CFR 888.3565 Regulation Names: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: May 6, 2003 Received: May 8, 2003
Dear Ms. Halevi:
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
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Page 2 - Ms. Marci Halevi
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. 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
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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510(k) Number (if known):
Device Name:
Trabecular Metal Tibial and Patellar Components for the NexGen Knee System
<031462
Indications For Use:
Trabecular Metal Tibial and Patellar Components for the NexGen Knee System are intended for use where severe degeneration, trauma, or other pathology of the knee ioint indicates cemented or cementless total knee arthroplasty.
(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
Muriam C. Provost
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
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.