(73 days)
Not Found
Not Found
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total knee arthroplasty component, intended to reduce pain and improve knee function for patients with various joint degenerative conditions or fractures, which aligns with the definition of a therapeutic device.
No
The device is an orthopedic implant for total knee arthroplasty, designed to replace a damaged knee joint, not to diagnose a condition.
No
The device description explicitly states it is a physical component manufactured from ultra high molecular weight polyethylene, which is a hardware material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a total knee arthroplasty component, specifically a tibial component made of polyethylene. Its intended use is for surgical implantation to replace a damaged knee joint and improve function and reduce pain.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. It is a physical implant used within the body.
Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
-
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and
-
- treatment of fractures that are unmanageable using other techniques.
This device is intended for use with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The ADVANCE All Polyethylene Tibial Component, size 8mm, is manufactured from ultra high molecular weight polyethylene. The device features cement pockets on the underside of the component. The device is designed to be used with bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature patients
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)
Submitted testing indicates that the device should withstand a load of 450 lbs for at least 10 million cycles. Additional testing indicates that no areas of unacceptable high stress were identified. Finally, testing provided indicates that the device provides adequate constraint for expected physiological loads.
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.
ADVANCE® Total Knee System All Polyethylene Tibial Components manufactured by Wright Medical Technology, Inc.
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
JAN 30 1998
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" on the left, followed by the company name in bold, uppercase letters. Below the name is the company's address: 5677 Airline Road, Arlington, TN 38002, and their phone number: 901-867-9971. At the bottom of the image, the number K974328 is handwritten.
Kim Tompkins Contact Person: November 17, 1997 Date:
510(k) Summary
| Trade Name: | ADVANCE® Total Knee System, All Polyethelene Tibial
Component, size 8mm |
|-------------------|------------------------------------------------------------------------------------------------------------------|
| Common Name: | Tibial Component |
| Classification: | Class II |
| Predicate Device: | ADVANCE® Total Knee System All Polyethylene Tibial
Components manufactured by Wright Medical Technology, Inc. |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Description/Intended Use
The ADVANCE All Polyethylene Tibial Component, size 8mm, is manufactured from ultra high molecular weight polyethylene. The device features cement pockets on the underside of the component. The device is designed to be used with bone cement.
This device is indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
-
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and
-
- treatment of fractures that are unmanageable using other techniques.
Testing
Submitted testing indicates that the device should withstand a load of 450 lbs for at least 10 million cycles. Additional testing indicates that no areas of unacceptable high stress were identified. Finally, testing provided indicates that the device provides adequate constraint for expected physiological loads.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Ms. Kim Tompkins Director, Clinical and Regulatory Affairs Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K974328 ADVANCE® Total Knee System, 8mm All Polyethylene Tibial Component Requlatory Class: II Product Code: ਹੈਂ ਮ November 17, 1997 Dated: Received: November 18, 1997
Dear Ms. Tompkins:
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:
- The thinnest tibial component available is the nominal 1. "8mm" sized component, which has a minimum polyethylene ... ా thickness under the condyles of 8.0mm.
-
- This device may not be labeled or promoted for noncemented use.
- All labeling for this device, including package label 3. and labeling included within the package, must prominently state that the device is intended for cemented use only.
2
Page 2 - Ms. Kim Tompkins
- Any non-cemented fixation of this device is considered 4 . 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. ਸ 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 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 Regulations.
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
3
Page 3 - Ms. Kim Tompkins
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.
2Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
C. Indications for Use of the Device
Page 1 of 1
| 510(k) Number (if known): | K974328 |
|---|---|
| --------------------------- | --------- |
Device Name: ADVANCE Total Knee System, product line addition to include the 8mm thick all poly tibial component
Indications for Use:
Indicated for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
-
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity;
★
-
- revision procedures where other treatments or devices have failed; and
-
- treatment of fractures that are unmanageable using other techniques .--
This device is intended for use with bone cement.
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Or Over-the-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number KG 7432
0000009