(51 days)
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.
The NexGen LPS-Flex Prolong articular surfaces are part of the NexGen system of semiconstrained,
The provided document describes a 510(k) premarket notification for a medical device, specifically NexGen® Complete Knee Solution LPS-Flex Prolong™ Highly Crosslinked Polyethylene Articular Surfaces. The document focuses on demonstrating substantial equivalence to predicate devices rather than a de novo study with explicit acceptance criteria and performance data.
Therefore, many of the requested categories (2-9) are not directly applicable or explicitly stated in this type of submission which primarily relies on equivalence to devices already on the market.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is a 510(k), which asserts substantial equivalence to predicate devices rather than establishing new performance acceptance criteria and showing performance against them in a de novo study. The "Performance Data" section explicitly states "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."
Therefore, a table of explicit acceptance criteria and reported device performance, as one would see in a de novo study, is not provided in this type of submission. The 'acceptance criterion' for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate. The 'performance' is therefore inherently linked to the performance of the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No dedicated "test set" or clinical study with a prospectively collected sample size is described as clinical data was not needed. The non-clinical performance refers to design assurance testing, which would typically involve laboratory testing, not a clinical test set. The provenance of such non-clinical data would be internal lab reports.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As clinical data and a test set requiring ground truth establishment by experts were not needed or presented, this information is not provided.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No clinical study, let alone an MRMC study comparing human readers with or without AI assistance, was performed or presented for this 510(k) submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical knee prosthesis component, not an algorithm or AI. Therefore, a standalone performance study in the context of an algorithm's performance is not relevant.
7. Type of Ground Truth Used
Not applicable, as no external "ground truth" for a clinical assessment was required. The "truth" in this context is established through engineering and material science testing that demonstrates the physical properties and performance characteristics (e.g., wear, strength) of the device are equivalent to the predicate.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.
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007 1 3 2004
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Brandon HipsherSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605 |
| Date: | October 12, 2004 |
| Trade Name: | NexGen® Complete Knee Solution LPS-FlexProlong™ Highly Crosslinked PolyethyleneArticular Surfaces |
| Common Name: | Total Knee Prosthesis |
| Classification Nameand Reference: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis21 CFR § 888.3560 (JWH)Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis21 CFR § 888.3565 (MBH) |
| Predicate Devices: | LPS-Flex Fixed Bearing Articular SurfaceComponents, manufactured by Zimmer, Inc.,K991581, cleared July 30, 1999.Prolong Highly Crosslinked Polyethylene CruciateRetaining (CR) Articular Surface Components,manufactured by Zimmer, Inc., K013991, clearedDecember 27, 2001.NexGen Porous, Uncemented Femoral and TibialBaseplate Components, manufactured by Zimmer,Inc., K031061, cleared October 9, 2003. |
| Device Description: | The NexGen LPS-Flex Prolong articular surfacesare part of the NexGen system of semiconstrained, |
| Intended Use: | This device is indicated for patients with severeknee pain and disability due to:- Rheumatoid arthritis, osteoarthritis,traumatic arthritis, polyarthritis.- Collagen disorders, and/or avascularnecrosis of the femoral condyle.- Post-traumatic loss of joint configuration,particularly when there is patellofemoralerosion, dysfunction or prior patellectomy- Moderate valgus, varus, or flexiondeformities.- The salvage of previously failed surgicalattempts or for a knee in which satisfactorystability in flexion cannot be obtained at thetime of surgery.The device is indicated for use when both cruciateligaments have been excised.The device is intended for use as part of a cementedor uncemented knee prosthesis. |
| Comparison to Predicate Device: | Except for a change in material and minordimensional modifications, LPS-Flex Prolongarticular surfaces are identical to the predicatedevice. The modifications do not change theintended use or the fundamental scientifictechnology. The device is packaged using the samematerials and processes. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:Performance testing completed as part of the designassurance process demonstrated that this device issafe and effective and substantially equivalent to thepredicate device.Clinical Performance and Conclusions:Clinical data and conclusions were not needed forthis 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
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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
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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_
Page 1 of 1
§ 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.