(86 days)
No
The document describes physical knee components and a sterilization process, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "components...in primary or revision cemented total knee arthroplasty," clearly indicating its use in treating a medical condition (damaged knee joints), which aligns with the definition of a therapeutic device.
No
This device is described as UHMWPE Knee components intended for use in total knee arthroplasty, which is a surgical procedure for replacement, not diagnosis. The information provided focuses on the materials and wear reduction, not on diagnostic capabilities.
No
The device description clearly states it is describing "additional UHMWPE Knee components," which are physical implants, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that these components are for "primary or revision cemented total knee arthroplasty." This is a surgical procedure involving the implantation of a medical device into the body.
- Device Description: The description details "additional UHMWPE Knee components" and their use in conjunction with other knee implant components.
- Anatomical Site: The anatomical site is the "Knee," indicating an internal body part.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. The performance studies focus on wear characteristics of the material, not diagnostic performance.
IVD devices are used outside the body to analyze samples from the body. This device is an implantable medical device used inside the body.
N/A
Intended Use / Indications for Use
The Kinemax® Superstabilizer (K904208), Kinematic® II Modular Condylar and Stabilizer Inserts (K871349), PCA® Modular Inserts (K894403), Kinematio® Rotating Hinge Knee (K792089), Duracon® Unicompartmental Knee (K 926231), and the Modular Replacement Metal Encapsulated Components (K952970) are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
This submission describes additional UHMWPE Knee components that can be sterilized by the Duration® Stabilized process previously cleared in submission K936292, as an alternate to standard air irradiated gamma sterilization. Corresponding wear claims, previously cleared in submission K 965173 and listed below, are also applicable to these additional components. This submission includes the Kinemax® Superstabilizer (K904208), the Kinematic® II Modular Condylar and Stabilizer Inserts (K871349), the PCA Modular Inserts(K894403), the Kinematic® Rotating Hinge Knee (K792089), the Duracon® Unicompartmental Knee (K926231), and the Modular Replacement Metal Encapsulated Components (K952970). These components are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.
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)
A block of Howmedica's Duration® Stabilized UHMWPE showed a 30% reduction in volumetric wear versus the same block of Howmedica's conventionally gamma sterilized UHMWPE. Testing was performed in a reciprocating ring-on-block wear test for over 5 million cycles, using a circular disk, 2.83" in diameter, 1" wide, CoCr articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
In an independent laboratory test, a 9mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE showed a 68% reduction in volumetric wear versus the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE. Testing was performed in a reciprocating pin-on-disk wear evaluation over 4 million cycles, using a CoCr cylindrical pin with a 1" spherical end as the articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
In an independent laboratory test, a 9 mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE, having undergone 23 days of heating in air to simulate 7-9 years of "aging", showed a 91% reduction in volumetric wear versus the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE, having undergone 23 days of heating in air to simulate 7-9 years of "aging". Testing was performed in a reciprocating pin-on-disk wear evaluations over 2.5 million cycles, using a CoCr cylindrical pin with a 1" spherical end as the articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
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.
K904208, K871349, K894403, K792089, K926231, K952970
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
K97 2863
510(k) Summary
Proprietary Name: Duration® Stabilized UHMWPE Knee Components
Common Name: UHMWPE Knee Components
OCT 29 1997
21 CFR 888.3560 Classification Name and Reference:
Proposed Requiatory Class: Class II Device Product Code: JWH
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 (201) 507-6870 Fax: Date Summary Prepared: 8-1-97
This submission describes additional UHMWPE Knee components that can be sterilized by the Duration® Stabilized process previously cleared in submission K936292, as an alternate to standard air irradiated gamma sterilization. Corresponding wear claims, previously cleared in submission K 965173 and listed below, are also applicable to these additional components.
This submission includes the Kinemax® Superstabilizer (K904208), the Kinematic® II Modular Condylar and Stabilizer Inserts (K871349), the PCA Modular Inserts(K894403), the Kinematic® Rotating Hinge Knee (K792089), the Duracon® Unicompartmental Knee (K926231), and the Modular Replacement Metal Encapsulated Components (K952970). These components are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.
Following are the wear claims that will be made for these devices:
A block of Howmedica's Duration® Stabilized UHMWPE showed a 30% reduction in volumetric wear versus the same block of Howmedica's conventionally gamma sterilized UHMWPE. Testing was performed in a reciprocating ring-on-block wear test for over 5 million cycles, using a circular disk, 2.83" in diameter, 1" wide, CoCr articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
1
In an independent laboratory test, a 9mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE showed a 68% reduction in volumetric wear versus the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE. Testing was performed in a reciprocating pin-on-disk wear evaluation over 4 million cycles, using a CoCr cylindrical pin with a 1" spherical end as the articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
In an independent laboratory test, a 9 mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE, having undergone 23 days of heating in air to simulate 7-9 years of "aging", showed a 91% reduction in volumetric wear versus the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE, having undergone 23 days of heating in air to simulate 7-9 years of "aging". Testing was performed in a reciprocating pin-on-disk wear evaluations over 2.5 million cycles, using a CoCr cylindrical pin with a 1" spherical end as the articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank Maas Requlatory Affairs Manager Howmedica, Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
OCT 2 9 1997
K972863 Re: Duration® Stabilized UHMWPE Trade Name: Knee Components Requlatory Class: II Product Code: JWH Dated: August 1, 1997 Received: August 4, 1997
Dear Mr. Maas:
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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:
- This device may not be labeled or promoted for non-1. cemented use.
- All labeling for this device, including package label 2. and labeling included within the package, must prominently state that the device is intended for cemented use only.
3
Page 2 - Mr. Frank Maas
- Any non-cemented fixation of this device is considered 3. investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be
4
Page 3 - Mr. Frank Maas
obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DURATION® WEAR CLAIMS - KNEE COMPONENTS
A block of Howmedica's Duration® Stabilized UHMWPE showed a 30% reduction in volumetric wear versus the same block of Howmedica's conventionally gamma sterilized UHMWPE. Testing was performed in a reciprocating ring-on-block wear test for over 5 million cycles, using a circular disk, 2.83" in diameter, 1" wide, CoCr articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
In an independent laboratory test, a 9 mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE showed a 68% reduction in volumetric wear versus the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE. Testing was performed in a reciprocating pin-on-disk wear evaluation over 4 million cycles, using a CoCr cylindrical pin with a 1" spherical end as the articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
In an independent laboratory test, a 9 mm thick circular disk of Howmedica's Duration® Stabilized UHMWPE, having undergone 23 days of heating in air to simulate 7-9 years of "aging", showed a 91% reduction in volumetric wear versus the same circular disk of Howmedica's conventionally gamma sterilized UHMWPE, having undergone 23 days of heating in air to simulate 7-9 years of "aging". Testing was performed in a reciprocating pin-on-disk wear evaluations over 2.5 million cycles, using a CoCr cylindrical pin with a 1" spherical end as the articulating counterface and bovine calf serum as a lubricant. The results of in vitro tests have not been shown to correlate with clinical wear mechanisms.
Prescription Use
(Per 21 CFR 801.109)
ACotter
Sign-Off of General Restorative (k) Number
6
Indications for Use
510(k) Number (if known):
Device Name: Duration® Stabilized UHMWPE Knee Components
Indications for Use:
The Kinemax® Superstabilizer (K904208), Kinematic® II Modular Condylar and Stabilizer Inserts (K871349), PCA® Modular Inserts (K894403), Kinematio® Rotating Hinge Knee (K792089), Duracon® Unicompartmental Knee (K 926231), and the Modular Replacement Metal Encapsulated Components (K952970) are intended to be used with the PCA®, Duracon®, or Kinemax® family of femoral components, tibial baseplates, and patellar components in primary or revision cemented total knee arthroplasty.
SEE NEXT PAGE FOR DURATION® WEAR CLAIMS
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General Restorative Devices
(Optional Format 1-2-96)
| 510(k) Number | K972863 |
|---|---|
| --------------- | --------- |