(29 days)
Not Found
No
The document describes a mechanical implant (femoral and tibial augments) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
Yes
The device is 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, which are therapeutic interventions.
No
The device description indicates that the NexGen Trabecular Metal femoral and tibial augments are used for the reconstruction of bony defects in knee reconstruction. This is a therapeutic purpose, not a diagnostic one.
No
The device description clearly describes physical implants (femoral and tibial augments) made of Trabecular Metal, designed for surgical implantation in the knee joint. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the NexGen Trabecular Metal femoral and tibial augments are physical implants designed for surgical use in the knee joint to reconstruct bony defects.
- Intended Use: The intended use is for surgical reconstruction and revision of knee procedures, not for analyzing biological samples.
The device is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The NexGen Trabecular Metal femoral and tibial 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 femoral and tibial augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.
Product codes
JWH
Device Description
The NexGen Trabecular Metal Augments are designed for attachment to selected commercially available NexGen tibial base plates and femoral components using either bolts, cement or a combination of both (depending on the augment). In the USA, the augment must be cemented to the bone surface; outside the USA the use of cement along the bone surface is optional.
The augments are manufactured to interface with selected femoral and tibial NexGen components. The femoral augments come in four different sizes (sizes C, D, E and F) that correspond with the sizes of the femoral components. Each NexGen LCCK or RHK femoral component has two corresponding augments, one for the distal segment and one for the posterior segment of the femoral component. The thickness options of the augments vary from 5mm to 20mm. The tibial augments are sized to match the tibial base plates. There are 6 sizes (sizes 2 through 7) of tibial augments to match the six sizes of the augmentable NexGen tibial base plates. Within each size, there are different thickness options (from 5mm - 20mm for sizes 2 and 7; from 5mm - 20mm for sizes 3, 4, 5, 6, and 10mm thick for full blocks for sizes 1-7), right-left configurations and the thicker sizes are tapered to mimic proximal tibial anatomy. The NexGen RHK full block tibial augments are 10mm thick and are offered in sizes 1 through 6.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the subject devices were not performed. Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K982302, K980781, K013385, K946150
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
NexGen® Complete Knee Solution - Trabecular Metal Augments
| Submitter Name
And Address: | Implex Corp.
80 Commerce Drive
Allendale, New Jersey 07401-1600 | JAN 1 5 2003 |
|------------------------------------|-----------------------------------------------------------------------|--------------|
| Contact Person: | Marci Halevi | |
| Phone Number: | (201) 818-1800 ext 507 | |
| Fax Number: | (973) 829-0825 | |
| Date Prepared: | December 16, 2002 | |
| Device Trade Name: | NexGen® Complete Knee Solution - Trabecular Metal
Augments | |
| Device Common Name: | Knee System Augments | |
| Classification Number
and Name: | 21 CFR § 888.3560
Prosthesis, Knee, Patellofemorotibial. | |
The term "substantial equivalence" as used in this 510(k) Substantial Equivalence: notification is limited to the definition of substantial equivalence found in the Federal Food, Druq 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. ্র 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 Augments are designed for attachment to Description: selected commercially available NexGen tibial base plates and femoral components using either bolts, cement or a combination of both (depending on the augment). In the USA, the augment must be cemented to the bone surface; outside the USA the use of cement along the bone surface is optional.
The augments are manufactured to interface with selected femoral and tibial NexGen components. The femoral augments come in four different sizes (sizes C, D, E and F) that correspond with the sizes of the femoral components. Each NexGen LCCK or RHK femoral component has two corresponding augments, one for the distal segment and one for the posterior segment of the femoral component. The thickness options of the augments vary from 5mm to 20mm. The tibial augments are sized to match the tibial base plates. There are 6 sizes (sizes 2 through 7) of tibial augments to match the six sizes of the augmentable NexGen tibial base plates. Within each size, there are different thickness options (from
1
Implex Corp
5mm - 20mm for sizes 2 and 7; from 5mm - 20mm for sizes 3, 4, 5, 6, and 10mm thick for full blocks for sizes 1-7), right-left configurations and the thicker sizes are tapered to mimic proximal tibial anatomy. The NexGen RHK full block tibial augments are 10mm thick and are offered in sizes 1 through 6.
Indications for Use: NexGen Trabecular Metal 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 femoral and tibial augments are for cemented use only in the USA, and for cementless or cemented use outside the USA. NexGen Trabecular Metal Augments are manufactured from the Device Technological
Characteristics and same material as approved Continuum Knee System Spacers. Comparison to Additionally, these augments have the same geometry as cleared Predicate Device: NexGen Knee System augments.
Testing of the subject devices were not performed. Performance Data: . Previous testing of Trabecular Metal and Trabecular Metal devices support a determination of substantial equivalence.
The NexGen Trabecular Metal Augments are substantially Conclusion: equivalent to the following predicate devices identified in this premarket notification:
| 510(k) # | Product Name | Company |
|---|---|---|
| K982302 | Hedrocel Tibial Spacers | Implex Corp. |
| K980781 | Hedrocel Revision Femoral Spacers | Implex Corp. |
| K013385 | NexGen Complete Knee Solution Rotating Hinge Knee | Zimmer, Inc. |
| K946150 | Cruciate Retaining (Augmentable) and Constrained Knee | Zimmer, Inc. |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
JAN 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marci Halevi Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401
Re: K024161
Trade/Device Name: NexGen® Complete Knee Solution - Trabecular Metal 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: December 16, 2002 Received: December 17, 2002
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 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 - Ms. Marci Halevi
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. 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) you may obtain. 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,
l Mark N. Mulkeran
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
4
Implex Corp.
510 (k) Number (if known) :
Device Name:
The NexGen® Complete Knee Solution - Trabecular Metal Augments
Indications For Use:
The NexGen Trabecular Metal femoral and tibial 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 femoral and tibial augments are for cemented use only in the USA, and for cementless or cemented use outside the USA.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED |
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescriptio n Use (Per 21 CFR 801.109) OR. .
Over - The -Counter Use
(Optional Format 1-2-96)
for Mark N. Mcherson
(Division Sign Off)
General. Restorative urclogical Devices
510(k) Number K02