(90 days)
Scorpio Knee System - Tibial Inserts
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No
The document describes a mechanical knee implant system and does not mention any AI/ML components or capabilities.
Yes
The device, a tibial insert component for total knee arthroplasty, is used to relieve painful, disabling joint disease and restore function to the knee, which are therapeutic actions.
No
Explanation: The provided text describes a knee replacement system used to treat joint disease, pain, and instability. It is an implantable device designed for surgical intervention rather than for diagnosing medical conditions.
No
The device description explicitly states it includes "tibial insert components," which are physical hardware implants used in knee replacement surgery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant used in total knee replacement surgery. It is a physical component implanted into the body to replace damaged joint surfaces.
- Intended Use: The intended use clearly states it's for "total knee arthroplasty" to address painful and disabling joint disease. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a Class II or Class III medical device (depending on the specific classification) used for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Scorpio® Knee System 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.
The Scorpio® Knee System components are for use in total knee arthroplasty as a result of:
- 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. .
These components are single use only and are intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The device includes the tibial insert components of a total knee system. These components are used for the replacement of the bearing surface of the proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Knee Joint; Patellofemorotibial; proximal tibia
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A risk analysis and Research and Development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. 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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Scorpio Knee System - Tibial Inserts
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| K033342 |
|---|
| 510(k) Premarket Notification |
1 6 46.
1 of
JAN 1 5 2004
Summary of Safety and Effectiveness
| Contact Person: | Denise Duchene
Sr. Regulatory Affairs Specialist
Howmedica Osteonics Corp.
59 Route 17 South
Allendale, NJ 07401
(201) 831-5612 (Phone)
(201) 831-6038 (FAX) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 17, 2003 |
| Device: | Scorpio ® Knee System - Tibial Inserts |
| Classification: | Knee Joint; Patellofemorotibial; Polymer/metal/polymer; Semi-
constrained; Cemented prosthesis - Class II -21 CFR 888.3560 |
| Predicate Devices: | Scorpio ® Knee System - Tibial Inserts |
| Indications for Use: | The Scorpio ® Knee System 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. |
| Proposed Modification: | Redesign of the tibial insert component dimensions to provide for
improved hyperextension. In addition, to provide a claim for the
CR insert that indicates it provides sufficient constraint for use
when the posterior cruciate ligament (PCL) is absent or non-
functioning. |
| Device Description: | The device includes the tibial insert components of a total knee
system. These components are used for the replacement of the
bearing surface of the proximal tibia to relieve pain, instability and
the restriction of motion due to degenerative bone disease,
including osteoarthritis, rheumatoid arthritis, failure of other
devices or trauma. |
| Summary of Data: | A risk analysis and Research and Development testing have been
performed to demonstrate equivalence of the proposed products to
the predicate devices. The testing includes range of constraint
testing, analysis of tibial insert post stress and contact stress/area
analysis. The results demonstrate equivalence. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Ms. Lorraine T. Montemurro Regulatory Affairs Manager Stryker Howmedica Osteonics 59 Route 17 South Allendale, New Jersey 07401
Re: K033342 Trade/Device Name: Scorpio® Knee System - Tibial Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, patellofemorotibial. polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: October 15, 2003 Received: October 17, 2003
Dear Ms. Montemurro:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
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); labcling (21 CFR Part 801); good manufacturing practice requirements as set 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,
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Page 2 - Ms. Lorraine T. Montemurro
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 A. Millerson
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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Konzade 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Scorpio® Knee System – Tibial Inserts
Indications for Use:
The Scorpio® Knec System components are for use in total knee arthroplasty as a result of:
- 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. .
These components are single use only and are intended for implantation with bone cement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | |
|---|---|---|
| OR | Over-the-Counter Use | |
| (Per 21 CFR 801.109) |
for Mark N Millan