(89 days)
The ADVANCE® Ultra-Congruent Tibial Insert 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.
The ADVANCE® Ultra-Congruent tibial insert is part of a total system that is indicated for use only with cement.
The ADVANCE® Ultra-Congruent tibial insert is part of a total system that is indicated for use only with cement. The ADVANCE® Ultra-Congruent Tibial Insert is manufactured from ultra high molecular weight polyethylene.
This document is a 510(k) summary for a medical device called the ADVANCE® Ultra-Congruent Tibial Insert. It describes the device, its intended use, materials, and a summary of testing performed to demonstrate substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state "acceptance criteria" in a quantitative manner with pass/fail thresholds. Instead, it describes comparability to a predicate device and adherence to industry standards, which serve as an implicit form of acceptance criteria for this 510(k) submission.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Testing) |
|---|---|
| Femoral-tibial contact area comparability to predicate device. | "Submitted femoral-tibial contact area testing demonstrates that the ADVANCE® Ultra-Congruent Tibial Insert is comparable to the predicate device." |
| Stability and resistance to displacement under physiological loads (femoral-tibial constraint). | "Submitted femoral-tibial constraint testing (anterior shear, medial shear, medial shear, lateral shear, and rotation) demonstrates that the ADVANCE® Ultra-Congruent Tibial Insert is expected to remain stable and resist displacement when subjected to appropriate physiological loads." |
| UHMWPE properties meet or exceed minimal properties of ASTM F 648. | "Submitted ultra high molecular weight polyethylene (UHMWPE) properties demonstrate that the ADVANCE® polyethylene components meet or exceed minimal properties of ASTM F 648." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the contact area testing, constraint testing, or UHMWPE properties testing. It also does not provide information on the data provenance such as country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a mechanical device, not an imaging or diagnostic device. Therefore, the concept of "ground truth" established by human experts in the context of diagnostic interpretation (e.g., radiologists) is not applicable here. The "truth" or performance is established through physical and material property testing against industry standards and predicate device benchmarks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or clinical adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to the 510(k) clearance of a mechanical knee implant, not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm. Performance is assessed through physical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the device's materials and mechanical properties is established by:
- Comparability to a legally marketed predicate device: The Intermedics Natural Knee Ultra-Congruent Tibial Insert.
- Adherence to established industry standards: Specifically, ASTM F 648 for Ultra High Molecular Weight Polyethylene.
- Expected physiological performance: Demonstrating stability and resistance to displacement under appropriate loads.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning model requiring training data.
9. How the ground truth for the training set was established
Not applicable. As this is a mechanical device, the concept of a "training set" and its "ground truth" in the context of predictive modeling does not apply.
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Image /page/0/Picture/0 description: The image shows the date "OCT 21 1997". The month is October, the day is the 21st, and the year is 1997. The text is written in a simple, sans-serif font.
Image /page/0/Picture/1 description: The image shows a black and white logo of what appears to be the letter 'W'. The 'W' is stylized with a thick, bold font and has a unique design element where the central part of the 'W' is broken into three distinct segments. A registered trademark symbol is located at the bottom right of the logo.
MEDICAL TECHNOLOGY, INC.
5 6 7 7 AIRLINE ROAD
ARLINGTON, TN 38002
901-867-9971
Contact Person: Dan Regan Date Prepared: 23 July 1997
510(k) SUMMARY
| Trade Name: | ADVANCE® Ultra-Congruent Tibial Insert |
|---|---|
| Common Name: | Total Knee Replacement Implant |
| Product Classification: | II |
| Predicate Device: | Intermedics Natural Knee Ultra-Congruent Tibial Insert |
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® Ultra-Congruent tibial insert is part of a total system that is indicated for use only with cement.
The ADVANCE® Ultra-Congruent Tibial Insert is indicated in total knee replacements for the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis; 2)
-
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and 4)
- treatment of fractures that are unmanageable using other techniques. ર)
Materials
The ADVANCE® Ultra-Congruent Tibial Insert is manufactured from ultra high molecular weight polyethylene.
Testing Summary
- Submitted femoral-tibial contact area testing demonstrates that the ADVANCE® Ultra-Congruent • Tibial Insert is comparable to the predicate device.
- Submitted femoral-tibial constraint testing (anterior shear, medial shear, medial shear, lateral . shear, and rotation) demonstrates that the ADVANCE® Ultra-Congruent Tibial Insert 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 meet or exceed minimal properties of ASTM F 648.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings outstretched, symbolizing strength and freedom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, emphasizing the organization's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1997
Mr. Dan Regan International Regulatory Affairs Manager Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
K972770 Re : ADVANCE® Ultra-Congruent Tibial Insert Requlatory Class: II Product Code: JWH Dated: July 23, 1997 Received: July 24, 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone You may, therefore, market your device subject to cement." the general controls provisions of the Act and the following limitations:
- The thinnest tibial insert available is the nominal 1. "10mm" sized insert, which has a minimum polyethylene thickness under the condyles of 6.00mm.
-
- 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.
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Page 2 - Mr. Dan Regan
- 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. 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 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 requlation (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 "
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Page 3 - Mr. Dan Regan
obtained from the Division of Small Manufacturers Assistance obcarned from the Bivibron or 6.0.2011 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
f
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
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Enclosure
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C. Indications for Use of the Device
510(k) Number (if known):
ADVANCE® Ultra-Congruent Tibial Insert Device Name: Indications for Use:
The ADVANCE® Ultra-Congruent Tibial Insert 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, 1) traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis; 2)
-
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and 4)
- treatment of fractures that are unmanageable using other techniques. ર)
The ADVANCE® Ultra-Congruent tibial insert is part of a total system that is indicated for use only with cement.
(Please do not write below this line-continue on another page if needed) * * * 水 * 水
Concurrence of CDRH, Office of Device Evaluation (ODE)
to cote
Division Sign Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972770
Or
Prescription Use_X_ (Per 21 CFR 801.109)
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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.