(101 days)
The Scorpio -Flex Posterior Stabilized Tibial Insert components are for use in total knee arthroplasty for painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis; post-traumatic loss of knee joint configuration and function; moderate varus, valgus or flexion deformity in with the ligamentous structures can be returned to adequate function and stability; and/or revision of previous unsuccessful knee replacement or other procedure, ligamentous instability requiring implant bearing surface geometries with increased constraint; and absent or non-functioning posterior cruciate ligament.
This submission is intended to address a design modification to the Scorpio® Flex Posterior Stabilized Tibial Insert components. The tibial insert components have been redesigned to provide for improved hyperextension. There has been no change to the intended use of the device.
This document describes a Special 510(k) Premarket Notification for a design modification to the Scorpio®-Flex Posterior Stabilized Tibial Insert Components. The modification aims to improve hyperextension. The submission focuses on demonstrating substantial equivalence to a predicate device through testing and analysis.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the device meets implied acceptance criteria through a comparison to a predicate device and specific tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device in Intended Use and Basic Design Concept | "The subject components share the same intended use and basic design concept as that of the predicate devices." |
| Demonstrates Equivalence in Performance | "A risk analysis, testing and analysis have been performed to demonstrate equivalence of the subject device to the predicate device." |
| Satisfactorily Addresses Range of Constraint | "The testing includes range of constraint testing... The results demonstrate equivalence." |
| Satisfactorily Addresses Tibial Insert Post Stress | "...analysis of tibial insert post stress... The results demonstrate equivalence." |
| Satisfactorily Addresses Contact Stress/Area | "...contact stress/area analysis. The results demonstrate equivalence." |
2. Sample size used for the test set and the data provenance
The document does not specify details about "test sets" in the context of clinical or image-based studies. The testing described (range of constraint, tibial insert post stress, contact stress/area analysis) appears to be bench testing or engineering analysis, not human subject data. Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for the engineering performance tests would be defined by established biomechanical principles and design specifications, not by expert human interpretation of data from a test set as would be the case for a diagnostic device.
4. Adjudication method for the test set
Not applicable. There is no mention of human-adjudicated data for this type of device modification.
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 is a knee implant component, not a diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm and does not have standalone performance in that sense. The performance is determined by its mechanical properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering tests, the "ground truth" would be the established mechanical properties, design specifications, and biomechanical standards for knee implant components, and the comparison to the performance characteristics of the predicate device.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. The design modification is based on engineering principles and testing.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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K 041/591
Special 510(k) Premarket Notification
Special 510(k) Summary of Safety and Effectiveness: Design Modification to the Scorpio -Flex Posterior Stabilized Tibial Insert Components
| Proprietary Name: | Scorpio®-Flex Posterior Stabilized Tibial Insert Components |
|---|---|
| Proposed Regulatory Class: | Class II |
| Classification: | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-constrained; Cemented prosthesis: 21 CFR 888.3560 |
| Device Product Code: | 87 JWH |
| For Information contact: | Karen AriemmaRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Telephone: (201) 831-5718Fax: (201) 831-6038Email: karen.ariemma@stryker.com |
| Date Summary Prepared: | June 9, 2004 |
Predicate Device Identification:
The Scorpio Total Knee System consists of various sizes of femoral, tibial and patellar components.
Description of Device Modification:
This submission is intended to address a design modification to the Scorpio® Flex Posterior Stabilized Tibial Insert components. The tibial insert components have been redesigned to provide for improved hyperextension. There has been no change to the intended use of the device.
Indications for Use:
The Scorpio -Flex Posterior Stabilized Tibial Insert components are for use in total knee arthroplasty for painful, disabling joint disease of the knee resulting from degenerative arthritis,
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rheumatoid arthritis or post-traumatic arthritis; post-traumatic loss of knee joint configuration and function; moderate varus, valgus or flexion deformity in with the ligamentous structures can be returned to adequate function and stability; and/or revision of previous unsuccessful knee replacement or other procedure, ligamentous instability requiring implant bearing surface geometries with increased constraint; and absent or non-functioning posterior cruciate ligament.
Statement of Technological Comparison:
The subject components share the same intended use and basic design concept as that of the predicate devices. A risk analysis, testing and analysis have been performed to demonstrate equivalence of the subject device to the predicate device. The testing includes range of constraint testing, analysis of tibial insert post stress and contact stress/area analysis. The results demonstrate equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2004
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, New Jersey 07430
Re: K041591
Trade/Device Name: Scorpio -Flex Posterior Stabilized Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: August 25, 2004 Received: August 26, 2004
Dear Ms. Ariemma:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Karen Ariemma
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Millenson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K041159
Device Name: Scorpio®-Flex Posterior Stabilized Tibial Insert
Indications
- Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis
- Post-traumatic loss of knee joint configuration and function .
- Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability;
- . Revision of previous unsuccessful knee replacement or other procedure;
- . Ligamentous instability requiring implant bearing surface geometries with increased constraint;
- Absent or non-functioning posterior cruciate ligament. .
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(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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Munk N. Millerson
. Restorative, sion of Genera Neurological Devices
510(k) Number K041591
§ 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.