(101 days)
Not Found
Not Found
No
The summary describes a mechanical modification to a tibial insert and does not mention any AI or ML components or functions.
Yes.
The device is a component for total knee arthroplasty, which is a surgical procedure to alleviate painful and disabling joint disease, indicating its use in treating a medical condition.
No
The device is a tibial insert component used in total knee arthroplasty, which is a surgical procedure to treat painful knee conditions. It is an implantable medical device, not a diagnostic tool used to identify or characterize a disease.
No
The device description clearly states it is a "Tibial Insert components" which are physical implants used in knee surgery, not software.
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 device used in total knee arthroplasty to treat painful and disabling joint disease of the knee. This is a surgical procedure involving the implantation of a medical device within the body.
- Device Description: The device is described as a "Tibial Insert component" for a total knee system. This is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVDs are used outside the body to analyze biological samples. This device is an implantable medical device used within the body.
N/A
Intended Use / 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, 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.
Product codes
87 JWH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Scorpio 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
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 Ariemma |
| Regulatory Affairs Specialist | |
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Telephone: (201) 831-5718 | |
| Fax: (201) 831-6038 | |
| Email: 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,
1
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.
2
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
3
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)
Page 1 of 1
Munk N. Millerson
. Restorative, sion of Genera Neurological Devices
510(k) Number K041591