(197 days)
The NexGen Trabecular Metal Tibial Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Tibial Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.
The NexGen Trabecular Metal Tibial Cone Augments are designed to be used in conjunction with Zimmer Inc.'s Legacy@ Stemmed Tibial Bases (LCCK) and Rotating Hinge Knee (RHK) tibial components. The subject devices are used to address proximal tibial cavitary defects encountered when implanting either of these two systems. The augments are manufactured from Trabecular Metal and have tapered posterior, medial and lateral walls. The periphery of the inferior surface is smaller than that of the superior surface. The augments are hollow such that they are to be filled with bone cement, and allow for placement of the stem and/or keel of the associated tibial base plate. Fixation of the augment to the tibial baseplate is accomplished by using bone cement. The inferior surface of the LCCK and RHK tibial baseplates must be cemented to bone. The Trabecular Metal Tibial Cone Augments are for cemented use along the bone in the USA, and for cementless or cemented use along the bone outside the USA.
This submission describes a medical device, the NexGen Trabecular Metal Tibial Cone Augments, and seeks to demonstrate its substantial equivalence to previously marketed predicate devices. This is a premarket notification for a medical device (510(k)), not a study to prove performance against specific acceptance criteria. Therefore, most of the requested information about a clinical study is not applicable to this document.
Here's a breakdown of the relevant information provided and how it addresses your request:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of acceptance criteria and reported device performance for the NexGen Trabecular Metal Tibial Cone Augments. The submission aims to establish substantial equivalence to predicate devices rather than proving performance against specific, pre-defined acceptance criteria through a new study.
The closest statement to "reported performance" is:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The submission is for substantial equivalence, not performance against pre-defined criteria. | "Testing of the subject devices were not performed. Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence. An engineering analysis was provided to support this." |
| Conclusion: "The NexGen Trabecular Metal Tibial Cone Augments are substantially equivalent to the predicate devices identified in this premarket notification." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No new test set or clinical study was performed for this 510(k) submission on the subject device. The determination of substantial equivalence was based on an engineering analysis and previous testing of the material (Trabecular Metal) and other Trabecular Metal devices, not a specific clinical test set for these augments.
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):
Not applicable. No clinical test set with ground truth established by experts was used for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set was used.
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 passive implant (tibial cone augment), not an AI-powered diagnostic tool. Therefore, an MRMC study or assessment of AI assistance for human readers is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No new ground truth was established for the subject device. The basis for the submission is demonstrating substantial equivalence through an engineering analysis and previously conducted testing on the material itself.
8. The sample size for the training set:
Not applicable. There was no "training set" in the context of an algorithm or AI model development. The basis of the submission is the material properties of Trabecular Metal and its prior use in other devices.
9. How the ground truth for the training set was established:
Not applicable. As there was no training set, there was no ground truth for a training set to be established.
In summary: This 510(k) submission for the NexGen Trabecular Metal Tibial Cone Augments relies on demonstrating substantial equivalence to existing predicate devices. This typically involves comparing device design, materials, manufacturing processes, and intended use. The submission states that "Testing of the subject devices were not performed" and instead, "Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence. An engineering analysis was provided to support this." This means the regulatory decision was made based on a comparison to known, safe, and effective devices already on the market, rather than a new clinical study with acceptance criteria and measured performance of this specific augment.
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JAN - 8 2004 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NexGen Trabecular Metal Tibial Cone Augments
| Submitter NameAnd Address: | Implex Corp.80 Commerce DriveAllendale, New Jersey 07401-1600 |
|---|---|
| Contact Person: | Marci Halevi |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (973) 829-0825 |
| Date Prepared: | October 9, 2003 |
| Device Trade Name: | NexGen Trabecular Metal Tibial Cone Augments |
| Device Common Name: | Knee System Augments |
| Classification Numberand Name: | 21 CFR § 888.3560Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. |
term "substantial equivalence" as used in this 510(k) Substantial The Equivalence: notification is limited to the definition of 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 or their application by the courts.
Device The NexGen Trabecular Metal Tibial Cone Augments are Description: designed to be used in conjunction with Zimmer Inc.'s Legacy@ Stemmed Tibial Bases (LCCK) and Rotating Hinge Knee (RHK) tibial components. The subject devices are used to address proximal tibial cavitary defects encountered when implanting either of these two systems. The augments are manufactured from Trabecular Metal and have tapered posterior, medial and The periphery of the inferior surface is smaller lateral walls. than that of the superior surface. The augments are hollow such that they are to be filled with bone cement, and allow for placement of the stem and/or keel of the associated tibial base plate. Fixation of the augment to the tibial baseplate is accomplished by using bone cement. The inferior surface of the LCCK and RHK tibial baseplates must be cemented to bone.
The Trabecular Metal Tibial Cone Augments are for cemented use along the bone in the USA, and for cementless or cemented use along the bone outside the USA.
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510(k) Summary (Continued)
Indications for Use: The NexGen Trabecular Metal Tibial Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Tibial Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA. Device Technological A comparison of device technological characteristics and Characteristics and properties demonstrates that the device is substantial Comparison to equivalent to the cited predicate devices. Predicate Device: Performance Data: Testing of the subject devices were not performed. Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence. An engineering analysis was provided to support this (reference Appendix A of the addendum.
- Conclusion: The NexGen Trabecular Metal Tibial Cone Augments are substantially equivalent to the predicate devices identified in this premarket notification.
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 2004
Ms. Marci IIalevi Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600
Rc: K031962
Trade/Device Name: NexGen Trabecular Metal Tibial Conc Augments 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: October 9, 2003 Received: October 10, 2003
Dear Ms. Halevi:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one re revealed 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 cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Fedcral Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and connette for (10) was the device, subject to the general controls provisions of the Act. The r ou may, diere, were, mains of the Act include requirements for annual registration, Insting of general voltation province, labeling, and prohibitions against misbranding and adulteration.
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elaintined toonal controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, IDA may publish further announcements concerning your device in the Fedcral 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 or uny reature and 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Marci Halevi
This letter will allow you to begin marketing your device as described in your Section 510(k) This tetter will anow you'ls cognifinding of substantial equivalence of your device to a legally prematicated 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 n you dobile of Compliance at (301) 594-4659. Also, please note the regulation entitled, eontact the Oriece of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small (Anergeneral 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. Milliman
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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Implex Corp
510(k) Number (if known) :
KO31962
Device Name:
The NexGen Trabecular Metal Tibial Cone Augments
Indications For Use:
The NexGen Trabecular Metal Tibial Cone Augments are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. The Trabecular Metal Tibial Cone Augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.
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Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescripti
on Use
(Per 21 CFR 801.109)
OR...
Over-The-
Counter Use
for Male n
(Optional Format 1-2-96)
vision Sig
Prision of C Restorative
And Neurolo... Devices
100 Num K031962
§ 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.