(51 days)
No
The summary describes a knee prosthesis component and does not mention any AI or ML capabilities.
Yes
The device is indicated for patients with severe knee pain and disability due to various conditions, aiming to alleviate pain and restore joint function as part of a knee prosthesis.
No
This device is a knee prosthesis, which is an implant used for treatment, not for diagnosis. The intended use describes conditions that the device treats, not conditions it diagnoses.
No
The device description and intended use clearly describe a physical knee prosthesis component, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for surgical implantation to treat severe knee pain and disability. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as part of a knee prosthesis, which is an implantable medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. -
- Collagen disorders and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities. -
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
The device is indicated for use when both cruciate ligaments have been excised. The device is intended for use as part of a cemented or uncemented knee prosthesis.
Product codes
JWH, MBH
Device Description
The NexGen LPS-Flex Prolong articular surfaces are part of the NexGen system of semiconstrained,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
007 1 3 2004
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brandon Hipsher
Specialist, Corporate Regulatory Affairs
Telephone: (574) 371-8083
Fax: (574) 372-4605 |
| Date: | October 12, 2004 |
| Trade Name: | NexGen® Complete Knee Solution LPS-Flex
Prolong™ Highly Crosslinked Polyethylene
Articular Surfaces |
| Common Name: | Total Knee Prosthesis |
| Classification Name
and Reference: | Knee joint patellofemorotibial polymer/metal/
polymer semi-constrained cemented prosthesis
21 CFR § 888.3560 (JWH)
Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis
21 CFR § 888.3565 (MBH) |
| Predicate Devices: | LPS-Flex Fixed Bearing Articular Surface
Components, manufactured by Zimmer, Inc.,
K991581, cleared July 30, 1999.
Prolong Highly Crosslinked Polyethylene Cruciate
Retaining (CR) Articular Surface Components,
manufactured by Zimmer, Inc., K013991, cleared
December 27, 2001.
NexGen Porous, Uncemented Femoral and Tibial
Baseplate Components, manufactured by Zimmer,
Inc., K031061, cleared October 9, 2003. |
| Device Description: | The NexGen LPS-Flex Prolong articular surfaces
are part of the NexGen system of semiconstrained, |
| Intended Use: | This device is indicated for patients with severe
knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis,
traumatic arthritis, polyarthritis. - Collagen disorders, and/or avascular
necrosis of the femoral condyle. - Post-traumatic loss of joint configuration,
particularly when there is patellofemoral
erosion, dysfunction or prior patellectomy - Moderate valgus, varus, or flexion
deformities. - The salvage of previously failed surgical
attempts or for a knee in which satisfactory
stability in flexion cannot be obtained at the
time of surgery.
The device is indicated for use when both cruciate
ligaments have been excised.
The device is intended for use as part of a cemented
or uncemented knee prosthesis. |
| Comparison to Predicate Device: | Except for a change in material and minor
dimensional modifications, LPS-Flex Prolong
articular surfaces are identical to the predicate
device. The modifications do not change the
intended use or the fundamental scientific
technology. The device is packaged using the same
materials and processes. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Performance testing completed as part of the design
assurance process demonstrated that this device is
safe and effective and substantially equivalent to the
predicate device.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for
this device. |
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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 is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings spread and its head turned to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2004
Mr. Brandon Hipsher Specialist, Corporate Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K042271
K042271
Trade/Device Name: NexGen® Complete Knee Solution LPS-Flex Prolong™ Highly Crosslinked Polyethylene Articular Surfaces Regulation Number: 21 CFR 888.3560 and 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis and Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: JWH and MBH
Dated: September 10, 2004 Received: September 13, 2004
Dear Mr. Hipsher
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bector. 910(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to ttg_as) actment date of the Medical Device Amendments, or to commence prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic 710-1710-11-28, subject to the general controls provisions of the Act. The Tourmay, therefore, thanket the act include requirements for annual registration, listing of general controlly provisions 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 If your device is classified (800 aborto) als. Existing major regulations affecting your device can may be subject to suen additional begulations, 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 I loase oe actived that I be mination that your device complies with other requirements of the Act that I Dri has made a assocd regulations administered by other Federal agencies. You must
3
Page 2 - Mr. Brandon Hipsher
comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the rice s requirements, 01); good manufacturing practice requirements as set CITY art 8077, adoling (21 CFR Part 820); and if applicable, the electronic forul in the qualis) byevelsions (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) This iciter will anow you to ogen mailing of substantial equivalence of your device to a legally premits to the nevice 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 If you desire specific acvice 10. Jour acon 2011) 276-0120. Also, please note the regulation entitled, contact the Office of Computer in (Et notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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. Millican
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
Indications for Use
510(k) Number (if known): Ko4227 |
Device Name:
NexGen® Complete Knee Solution LPS-Flex Prolong™ Highly Crosslinked Polyethylene Articular Surfaces
Indications for Use:
This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. -
- Collagen disorders and/or avascular necrosis of the femoral condyle. ।
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
- Moderate valgus, varus or flexion deformities. -
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
The device is indicated for use when both cruciate ligaments have been excised. The device is intended for use as part of a cemented or uncemented knee prosthesis.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Mark A. Millauer
Sion-(){}) Division of General, Restorative, and Neurological Devices
K04227
510(k) Number_
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