(57 days)
The tibial baseplate stem plugs are intended for cemented use in the following diagnostic indications:
-
- Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
-
- Correctable valgus-varus deformity and moderate flexion contracture.
-
- Those patients with failed previous surgery where pain, deformity, or dysfunction persist.
-
- Revision of previously failed knee arthroplasty.
The Sulzer Orthopedics Apollo Revision/Constrained Knee Tibial Baseplate Stem Plugs ("plug"), manufactured from wrought (ASTM F136) titanium alloy, are designed to fit into the female connection of the baseplate keel when no tibial stem component is used. The plug is connected to the baseplate component via a small set screw. The plugs therefore act to restrict the flow of bone cement into the baseplate component is intended for use with the Apollo Revision/Constrained Knee Tibial Baseplate.
The provided text is related to the 510(k) summary for the Sulzer Orthopedics Apollo Constrained/Revision Knee Tibial Baseplate Stem Plugs. This document outlines the regulatory submission for a medical device and its intended use, rather than a diagnostic device with performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, and ground truth establishment is not present in the provided text. The document focuses on establishing substantial equivalence to previously marketed devices based on design and material analysis, rather than a clinical performance study with specific diagnostic outcomes.
However, based on what is available, here's a breakdown of some of the requested points, noting where information is absent due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criteria" for this specific 510(k) submission, as indicated by the document, is the demonstration of substantial equivalence to legally marketed predicate devices. This is a regulatory benchmark rather than a performance metric. The acceptance criterion related to the device's function is its ability to "survive physiologic loading."
- Reported Device Performance: The only reported performance in the provided text is: "Analysis indicated that the device would survive physiologic loading." No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity) are reported.
| Acceptance Criteria (Regulatory/Functional) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices | Deemed substantially equivalent to listed predicate devices. |
| Device would survive physiologic loading | "Analysis indicated that the device would survive physiologic loading." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided as a formal "test set" and associated clinical data are not part of this 510(k) summary. The submission relies on design analysis and comparison to predicate devices, not a clinical study with a test set of patient data.
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 information is not provided. The "ground truth" concept is not applicable here as this is a device for knee replacement components, not a diagnostic tool requiring expert interpretation of results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. Adjudication methods are relevant for studies involving human interpretation of diagnostic results, which is not the case here.
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
- This information is not provided. An MRMC study is not relevant to this type of device (a knee implant component). This device does not involve AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not provided. This device is a passive mechanical component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This concept is not applicable to this device. The "truth" in this context would be related to the mechanical integrity and biological compatibility of the implant, assessed through engineering analysis and material standards, not diagnostic ground truth.
8. The sample size for the training set
- This information is not provided. There is no "training set" as this is not an AI/ML-based device.
9. How the ground truth for the training set was established
- This information is not provided. This is not an AI/ML-based device, so the concept of a training set and its ground truth is not applicable.
In summary, the provided FDA 510(k) summary is for a physical medical device (tibial baseplate stem plugs) and primarily focuses on demonstrating substantial equivalence to existing predicate devices through design comparison and mechanical analysis rather than clinical performance studies with diagnostic metrics.
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510(k) SUMMARY
K-983733
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the Sulzer Orthopedics Apollo Constrained/Revision Knee Tibial Baseplate Stem Plugs.
| Submitter: | Sulzer Orthopedics Inc.9900 Spectrum DriveAustin, Texas 78717(512) 432-9900 |
|---|---|
| Date: | October 16, 1998 |
| Contact Person: | Mitchell A. Dhority, RACManager, Regulatory Affairs |
| Classification Name: | Prosthesis, knee, patellofemorotibial, semi-constrained,cemented, polymer/ metal/polymer 21 CFR 888.3560 |
| Common/Usual Name: | Knee Prosthesis, Partially Constrained |
| Trade/Proprietary Name: | Sulzer Orthopedics Apollo Constrained/Revision Knee SystemTibial Baseplate Stem Plugs |
PRODUCT DESCRIPTION
The Sulzer Orthopedics Apollo Revision/Constrained Knee Tibial Baseplate Stem Plugs ("plug"), manufactured from wrought (ASTM F136) titanium alloy, are designed to fit into the female connection of the baseplate keel when no tibial stem component is used. The plug is connected to the baseplate component via a small set screw. The plugs therefore act to restrict the flow of bone cement into the baseplate component is intended for use with the Apollo Revision/Constrained Knee Tibial Baseplate.
SPECIFIC DIAGNOSTIC INDICATIONS
The tibial baseplate stem plugs are intended for cemented use in the following diagnostic indications:
-
- Patient conditions, including but not limited to, inflammatory degenerative joint disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
-
- Correctable valgus-varus deformity and moderate flexion contracture.
-
- Those patients with failed previous surgery where pain, deformity, or dysfunction persist.
-
- Revision of previously failed knee arthroplasty.
SUBSTANTIAL EQUIVALENCE
The Sulzer Orthopedics Fluted Stems are substantially equivalent to stem plugs used with the Maxim Constrained Knee (Biomet), the Coordinate Revision Knee (DePuy), Kinemax Plus Super Stabilizer (Howmedica), and the PFC - TC3 (Johnson and Johnson).
Analysis indicated that the device would survive physiologic loading.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1998
Mitchell A. Dhority, RAC Manager, Regulatory Affairs Sulzer Orthopedics, Inc. 9900 Spectrum Drive Austin, Texas 78717
K983733 Re: Sulzer Orthopedics Apollo Trade Name: Constrained/Revision Knee System Tibial Baseplate Stem Pluqs Regulatory Class: II Product Code: JWH Dated: October 21, 1998 Received: October 22, 1998
Dear Mr. Dhority:
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 requirements 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 Requlations, Title 21, Parts 800 to 895. ਕੇ 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.
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Page 2 - Mitchell A. Dhority, RAC
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 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 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
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510(k) Number (if known): k983 733
Device Name: Apollo Revision/Constrained Knee System Tibial Baseplate Stem Plug
Indications For Use:
The tibial baseplate stem plugs are intended use in the following diagnostic indications:
- Patient conditions, including but not limited to, inflammatory degenerative joint -1. disease (e.g., rheumatoid arthritis) and noninflammatory degenerative joint disease (e.g., osteoarthritis, avascular necrosis).
-
- Correctable valgus-varus deformity and moderate flexion contracture.
- Those patients with failed previous surgery where pain, deformity, or 3. dysfunction persist.
- Revision of previously failed knee arthroplasty. 4.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use X
OR
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.