(29 days)
JWH
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description is purely mechanical.
Yes
Explanation: The device is indicated for use in total knee arthroplasty for the reduction or relief of pain and/or improved knee function, which are therapeutic benefits.
No
This device is a total knee arthroplasty system intended for the treatment of knee conditions, not for diagnosing them. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it consists of "femoral and femoral augments, and tibial inserts," which are physical hardware components used in knee arthroplasty.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total knee arthroplasty. This is a medical device used in vivo (within the body) to treat a physical condition.
- Device Description: The device components (femoral and femoral augments, tibial inserts) are physical implants designed to be placed within the knee joint.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The ADVANCE® Revision Product Line Extension components are 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.
These products are for use with cement only.
Product codes
JWH
Device Description
The ADVANCE® Revision Product Line Extension components consists of femoral and femoral augments, and tibial inserts intended to be used only 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)
Testing meets the requirements cited in the FDA Guidance Documents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ADVANCE® Total Knee System
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
3 399 FEB
Image /page/0/Picture/1 description: The image shows a logo with a large, stylized letter 'W' on the left. To the right of the 'W', the word 'MEDICAL' is vertically stacked. Below 'MEDICAL', there are numbers '5 6 7 7' and the letters 'A R L I' stacked vertically. The logo appears to be for a medical-related entity, possibly a clinic or healthcare provider.
Contact Person: Lynne Witkowski Date Prepared: December 31, 1998
ABBREVIATED 510(k) SUMMARY
| Trade Name: | ADVANCE® Revision Product Line Extension |
|---|---|
| Common Name: | Total Knee Revision Replacement Implant |
| Product Classification: | II |
| Predicate Device: | ADVANCE® Total Knee System |
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® Revision Product Line Extension components consists of femoral and femoral augments, and tibial inserts intended to be used only with bone cement.
The ADVANCE® Revision Product Line Extesion components are indicated in total knee replacements for the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.
Materials
The ADVANCE® revision femoral component is manufactured from cobalt chrome alloy. The tibial components are manufactured from ultra high molecular weight polyethylene. The femoral augments are manufactured form titanium.
Testing Summary
Testing meets the requirements cited in the FDA Guidance Documents.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image of three human profiles facing right. The profiles are connected by a flowing line, symbolizing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 FEB
Ms. Lynne Witkowski Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re : K990030 Advance® Revision Product line Extension Requlatory Class: II Product Code: JWH Dated: December 31, 1998 Received: January 5, 1999
Dear Ms. Witkowski:
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 insert available is the nominal "mm" 1. sized 10 insert, which has a minimum polyethylene thickness under the condyles of 6 mm.
- This device may not be labeled or promoted for non-2. cemented 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.
- 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
2
Page 2 - Ms. Lynne Witkowski
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. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 Requlations.
This letter will allow you to beqin 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. Lynne Witkowski
obtained from the Division of Small Manufacturers Assistance obeathed from the Division of 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Nil RPO Alm for
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
4
Indications for Use of the Device C.
| 510(k) Number (if known): | K990030 |
|---|---|
| --------------------------- | --------- |
ADVANCE® Revision Product Line Extension Device Name:
Indications for Use:
The ADVANCE® Revision Product Line Extension components are 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, 1) traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis; 2)
- correction of functional deformity; 3)
- revision procedures where other treatments or devices have failed; and 4)
- treatment of fractures that are unmanageable using other techniques. ર)
These products are for use with cement only.
(Please do not write below this line-continue on another page if needed) * 水 * * * 水 水 *
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR 801.109) Or
Over-the-Counter Use
(Optional Format 1-2-96)
NRBC
(Division sign-on tera
Division of General Restorative Devices
510(k) Number
SIVE LIFES
K990030
000
0000000