(77 days)
The ADVANCE® Total Knee System 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.
The ADVANCE® knee system components consists of femoral and modular tibial inserts intended to be used only with bone cement.
The ADVANCE® femoral component is manufactured from cobalt chrome alloy. The tibial components are manufactured from ultra high molecular weight polyethylene.
The provided text describes a 510(k) summary for the ADVANCE® knee system components, which are total knee replacement implants. It details the device's description, intended use, materials, and a testing summary. However, it does not contain the specific information required to adequately complete the table and answer the questions as it pertains to a study proving acceptance criteria for an AI/device. The document focuses on mechanical testing of the physical implant components and comparability to a predicate device, not on AI-driven performance or studies involving human readers or ground truth.
Therefore, the following information cannot be extracted from the provided text:
- Acceptance Criteria and Reported Device Performance Table: The document lists types of mechanical tests and states the device is "comparable to the predicate device" or "demonstrates" certain properties, but it does not quantify acceptance criteria (e.g., specific thresholds for contact area, shear resistance) or precise performance metrics.
- Sample size for the test set and data provenance: Not applicable as no AI/device performance study is documented.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document's "Testing Summary" refers to bench testing of the physical components of the knee system, confirming their mechanical properties and comparability to a predicate device (Axiom Total Knee System). This is a different type of validation than what is requested, which seems to pertain to a diagnostic or AI-powered medical device.
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Image /page/0/Picture/0 description: The image shows a stylized letter "W" logo. The "W" is formed by three thick, black, angled lines that converge at the bottom, creating a triangular shape. To the right of the "W" and slightly below it, there is a small circled "R" symbol, indicating a registered trademark.
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology, Inc. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the address: 5677 Airline Road, Arlington, TN 38002, and the phone number: 901-867-9971.
K972626
Sept. 29, 1997
Contact Person: Dan Regan Date Prepared: July 11, 1997
510(k) SUMMARY
| Trade Name: | ADVANCE® knee system components |
|---|---|
| Common Name: | Total Knee Replacement Implant |
| Product Classification: | II |
| Predicate Device: | Axiom 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® knee system components consists of femoral and modular tibial inserts intended to be used only with bone cement.
The ADVANCE® knee system 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® femoral component is manufactured from cobalt chrome alloy. The tibial components are manufactured from ultra high molecular weight polyethylene.
Testing Summary
- Submitted patella-femoral contact area testing demonstrates that the ADVANCE® knee system . component is comparable to the predicate device.
- Submitted femoral-tibial contact area testing demonstrates that the ADVANCE® knee system . component is comparable to the predicate device.
- Submitted patella-femoral lateral stability testing demonstrates that the ADVANCE® knee system . component resists lateral subluxation similar to the predicate device.
- Submitted femoral-tibial constraint testing (anterior shear, posterior shear, medial shear, lateral . shear, and rotation) demonstrates that the ADVANCE® knee system component is expected to remain stable and resist displacement when subjected to appropriate physiological loads.
- Submitted ultra high molecular weight polyethylene (UHMWPE) properties demonstrate that the . ADVANCE® polyethylene components should perform adequately.
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Image /page/1/Picture/2 description: The image is a seal or logo. It features the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around a central emblem. The emblem consists of three stylized, curved lines that appear to be interconnected, possibly representing a symbol or abstract design.
SEP 2 9 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan Reqan ·International Regulatory Affairs Manager Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002
Re: K972626 ADVANCE® Total Knee System Trade Name: Regulatory Class: II Product Code: JWH July 11, 1997 Dated: Received: July 14, 1997
Dear Mr. Regan:
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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 (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 Requlation (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 action. In addition, FDA may publish further announcements 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.
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Page 2 - Mr. Dan Regan
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 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 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
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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C. Indications for Use of the Device
| 510(k) Number (if known): | K972626 |
|---|---|
| --------------------------- | --------- |
ADVANCE® Total Knee System Tibial Insert and Femoral Device Name: Component
Indications for Use:
The ADVANCE® Total Knee System 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;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and
- 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)
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)
pucellz
(Division Sign-Off) Division of General Restorative Devices 510(k) Number.
00007
§ 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.