(21 days)
Not Found
Not Found
No
The summary describes a physical implant (tibia component) made of specific materials, with no mention of software, algorithms, or any computational processing that would suggest AI/ML.
Yes
The device is a medical implant (Tibial component for knee arthroplasty) intended to treat severe degeneration, trauma, or pathology of the knee joint, which falls under the definition of a therapeutic device.
No
The provided text describes a knee implant (LPS - Continuum® TM Hybrid Tibia) used for total knee arthroplasty, indicating its purpose is for treatment/replacement rather than diagnosis.
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 pathology. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical implant made of metal and plastic, designed to be surgically placed within the body. IVDs are typically reagents, kits, or instruments used to test samples outside the body (in vitro).
- Lack of IVD characteristics: There is no mention of testing biological samples, analyzing biomarkers, or providing diagnostic information.
Therefore, the LPS - Continuum® TM Hybrid Tibia is a medical device, specifically a surgical implant, and not an IVD.
N/A
Intended Use / Indications for Use
The LPS - Continuum® TM Hybrid Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the LPS -Continuum® TM Hybrid Tibia is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.
Product codes
JWH
Device Description
The LPS - Continuum TM Hybrid 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 LPS 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 (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
Implex Corp.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| The LPS - Continuum TM Hybrid Tibia | |
|---|---|
| Submitter Name: | Implex Corp. |
| Submitter Address: | 80 Commerce Drive |
| Allendale, New Jersey 07401-1600 | |
| Contact Person: | Robert Poggie |
| Phone Number: | (201) 818-1800 |
| Fax Number: | (201) 995-9722 |
| Date Prepared: | June 29, 2001 |
| Device Trade Name: | The LPS - Continuum TM Hybrid Tibia |
| Device Common | |
| Name: | Articular Surface and 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 LPS - Continuum TM Hybrid 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 LPS Femoral components.
1
510(k) Summary (Continued)
Indications for Use:
The LPS - Continuum® TM Hybrid Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the LPS - Continuum TM Hybrid Tibia is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.
Conclusion:
The LPS - Continuum TM Hybrid Tibia is substantially equivalent to the identified predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three horizontal lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2001
Dr. Robert A. Poggie Director of Applied Research Implex Corp. 80 Commerce Drive. Allendale, New Jersey 07401
Re: K012095
Trade Name: The LPS-Continuum ™ Hybrid Tibia Regulatory Class: II Regulation Number: 888.3560 Product Code: JWH Dated: July 3, 2001 Received: July 5, 2001
Dear Dr. Poggie:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
3
Page 2 - Dr. Robert A. Poggie
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific a in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in This anagliestions on the promotion and advertising of your device, (2017) 594-4639. Rudinonary, 10. queens at (301) 594-4639. Also, please note the regulation prease connact the office or Scrence to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Machluurks
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
510(k) Number (if known) :
l2.PT
Device Name:
The LPS- Continuum® TM Hybrid Tibia
Indications For Use:
The LPS - Continuum® TM Hybrid Tibia is intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates cemented total knee arthroplasty. In addition, the LPS -Continuum® TM Hybrid Tibia is indicated for use in the presence of knee instability caused by a compromised or non-functional posterior cruciate ligament.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Bhatthee to tai iun
(Division Sign-O Division of General, Restorative and Neurological Devices Counter Use 510(k) Number KO12099
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)