(15 days)
Not Found
Not Found
No
The summary describes a physical implant (tibia component) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a knee implant used for total knee arthroplasty, which is a surgical procedure to treat severe degeneration or trauma, making it a treatment device rather than a diagnostic or therapeutic one in the typical sense of delivering therapy.
No
The device, "NexGen LPS Trabecular Metal Monoblock Tibia," is an orthopedic implant for total knee arthroplasty, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly 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, this device 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 used in vivo (within the body).
- Device Description: The description details the materials and construction of a physical implant (Trabecular Metal and UHMWPE).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. This device is clearly a surgical implant.
N/A
Intended Use / Indications for Use
The NexGen LPS TM Monoblock Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The NexGen LPS TM Monoblock Tibia is manufactured from Trabecular Metal (Hedrocel Porous Tantalum) with direct compression molded ultra-high molecular weight polyethylene (UHMWPE).
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)
Not Found
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.
Not Found
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
1/2
.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| The NexGen LPS TM Monoblock Tibia | |
|---|---|
| Submitter Name: | Implex Corp. |
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Les Heimann |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 995-9722 |
| Date Prepared: | January 24, 2001 |
| Device Trade Name: | The NexGen LPS Trabecular Metal Monoblock Tibia |
| Device Common | |
| Name: | Tibial Components |
| Classification Number | |
| and Name: | 21 CFR § 888.3560 |
| Substantial | |
| Equivalence: | The term "substantial equivalence" as used in this |
| 510(k) 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 Description: | The NexGen LPS TM Monoblock Tibia is manufactured |
| from Trabecular Metal (Hedrocel Porous Tantalum) with | |
| direct compression molded ultra-high molecular weight | |
| polyethylene (UHMWPE). |
1
The NexGen LPS TM Monoblock Tibia Special 510(k) Premarket Notification
510(k) Summary (Continued)
The NexGen LPS TM Monoblock Tibia is intended for use Indications for Use: where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
The NexGen LPS TM Monoblock Tibia is substantially Conclusion: equivalent to the 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 symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
FFB 2 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Les Heimann Director of Regulatory Affairs Implex Corp. 80 Commerce Drive. Allendale, New Jersey 07401
Re: K020295
Trade Name: NexGen LPS TM Monoblock Tibia Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotbibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Code: JWH
Dated: January 25, 2002 Received: January 28, 2002
Dear Mr. Heimann:
This letter corrects our substantially equivalent letter of February 12, 2002, regarding the trade name.
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). 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 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 - Mr. Les Heimann
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,
Miriam C. Provost
for 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 LPS TM Monoblock Tibia
Indications For Use:
The NexGen LPS Trabecular Metal Monoblock Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty.
Muriam C. Provost
eral. Restorative and Neurological Devices
026295 510(k) Number
(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)