(23 days)
Not Found
No
The summary describes a mechanical knee replacement component made of polyethylene. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as being intended to "reduce or relieve pain and restore function and motion to the knee joint," which are therapeutic benefits. It is a part of a total knee replacement system, which clearly falls under therapeutic interventions.
No
The device description indicates it is a component for total knee replacement, intended to reduce pain and restore function, not to diagnose a medical condition.
No
The device description explicitly states the components are manufactured of machined Ultra-High Molecular-Weight (UHMWPE) polyethylene, indicating a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a total knee replacement device. Its intended use is to be surgically implanted to replace a damaged knee joint and restore function. This is an implantable medical device, not a device used to test samples outside the body.
The information provided focuses on the material, manufacturing, intended surgical use, and performance of a knee implant, which are all characteristics of a non-IVD medical device.
N/A
Intended Use / Indications for Use
This device is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.
Prolong crosslinked polyethylene cruciate retaining articular surfaces are intended to be used as part of a cemented knee system.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
These components are manufactured of machined Ultra-High Molecular-Weight (UHMWPE) polyethylene. Both the modified and predicate devices are crosslinked by exposure to electron-beam (e-beam) radiation.
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)
Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device.
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.
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
12013991
DEC 2 7 2001
Summary of Safety and Effectiveness
Submitter:
Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708 (219) 267-6131
Stephen McKelvey Manager, Regulatory Affairs (219) 372-4944 (219) 372-4605
December 20, 2001
Prolong™ Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component
Crosslinked Articular Surfaces
Knee joint patellofemorotibial polyethylene/ metal/ polyethylene semiconstrained cemented total knee prosthesis - 21 CFR 888.3560
The predicate device for the Prolong CR Articular Surface Component is the NexGen® Complete Knee Solution Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component, K003910, cleared March 19, 2001.
These components are manufactured of machined Ultra-High Molecular-Weight (UHMWPE) polyethylene. Both the modified and predicate devices are crosslinked by exposure to electron-beam (e-beam) radiation.
Contact Person:
Telephone: Fax:
Date:
Trade Name:
Common Name:
Classification Name and Reference
Predicate Devices:
Device Description:
1
Intended Use:
This device is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended to be used as part of a cemented knee system.
Except for a minor modification to the patellar cutout, Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Components are identical to the predicate device. The modification does not change the intended use or the fundamental scientific technology. It is packaged and sterilized using the same materials and processes.
Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device.
Comparison to Predicate Devices:
Performance Data:
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2001
Mr. Stephen H. McKelvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K013991
. Trade/Device Name: Prolong™ Highy Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: December 3, 2001 Received: December 4, 2001
Dear Mr. McKelvey:
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 – Mr. Stephen H. McKelvey
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 prematicated nodicate 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,
Sincerely yours,
Mark A. Milkenon
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
Page 1 of 1
510(k) Number (if known): K013991
Device Name:
Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component
Indications for Use:
This device is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.
Prolong crosslinked polyethylene cruciate retaining articular surfaces are intended to be used as part of a cemented knee system.
(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) |
| ------------------------------------------ | ------------------------------------------ | -------------------------------------------------- |
|---|
for Mark N Milburn
(Division Sign-On)
Division of Gastroenterology, Restorative
and Neurological Devices
| 510(k) Number | K013991 |
|---|---|
| --------------- | --------------------------------------------------------- |
000009