(30 days)
Not Found
No
The document describes a mechanical knee implant component and its modifications for manufacturability and constraint, with no mention of AI or ML technology.
No
The device is an orthopedic implant (tibial insert) used in knee replacement surgery, which is a medical device designed to treat a medical condition by replacing a body part, rather than directly diagnosing, preventing, monitoring, treating, or alleviating disease independently.
No
The device is an orthopedic implant (tibial bearing insert) used in knee replacement surgery, not a tool for diagnosing diseases. Its intended use describes treatment for painful joint diseases and post-traumatic conditions, not detection or analysis.
No
The device description clearly indicates it is a physical implant (tibial bearing inserts) made of materials intended for surgical implantation, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Scorpio® CR Superflex™ Tibial Bearing Inserts are implants intended for use in knee replacement surgery. They are physical components designed to be surgically placed within the body to restore joint function.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's health status. Its purpose is purely therapeutic and structural.
Therefore, this device falls under the category of a medical device (specifically, an orthopedic implant), but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the modified tibial bearing inserts is identical to that of the unmodified tibial bearing inserts. As with the predicate inserts, the modified inserts are single use devices. They are intended for mating with commercially available Howmedica Osteonics tibial trays and patellas and corresponding Howmedica Osteonics cruciate retaining femoral components. Howmedica Osteonics Scorpio® CR Total Knee components are intended for cemented fixation.
The indications for the modified Scorpio® CR Superflex™ tibial inserts will remain the same as the indications for the current Scorpio® CR inserts. These are:
- 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 .
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Scorpio® CR Superflex™ tibial inserts share critical design features as the predicate Scorpio® CR tibial inserts. They have a barb and wire locking mechanism for mating with the appropriate Howmedica Osteonics tibial trays and are compatible with the current Scorpio® patella and CR femoral components. The subject inserts will be available in the same range of sizes and thicknesses as the current Scorpio® CR inserts.
The modifications incorporated with the Scorpio® CR Superflex™ inserts address ease of manufacturability and constraint in internal rotation. These modifications include increasing the anterior radius of the sagittal curve and adding a patella recess feature.
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)
Static testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts.
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.
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
510(k) Summary Scorpio® CR Superflex TM Tibial Inserts
JUN 2 8 2001
510(k) Summary Scorpio® CR Superflex™ Tibial Insert
Submission Information
Name and Address of the Sponsor of the 510(k) Submission:
Contact Person:
Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677
Mary-Catherine Dillon Regulatory Affairs Specialist
Date of Summary Preparation:
June 21, 2001
Device Identification
Proprietary Name:
Scorpio® CR Superflex™ Tibial Insert
Common Name:
Knee Prosthesis
Classification Name and Reference:
Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis 21 CFR '888.3560
Predicate Device Identification
The Scorpio® CR Superflex™ Tibial Bearing Inserts are substantially equivalent to the Scorpio® CR Tibial Bearing Inserts cleared via K974556.
Device Description
The Scorpio® CR Superflex™ tibial inserts share critical design features as the predicate Scorpio® CR tibial inserts. They have a barb and wire locking mechanism for mating with the appropriate Howmedica Osteonics tibial trays and are compatible with the current Scorpio® patella and CR femoral components. The subject inserts will be
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1
510(k) Summary Scorpio® CR SuperflexTM Tibial Inserts
available in the same range of sizes and thicknesses as the current Scorpio® CR inserts.
The modifications incorporated with the Scorpio® CR Superflex™ inserts address ease of manufacturability and constraint in internal rotation. These modifications include increasing the anterior radius of the sagittal curve and adding a patella recess feature.
Intended Use
The intended use of the modified tibial bearing inserts is identical to that of the unmodified tibial bearing inserts. As with the predicate inserts, the modified inserts are single use devices. They are intended for mating with commercially available Howmedica Osteonics tibial trays and patellas and corresponding Howmedica Osteonics cruciate retaining femoral components. Howmedica Osteonics Scorpio® CR Total Knee components are intended for cemented fixation.
Indications
The indications for the modified Scorpio® CR Superflex™ tibial inserts will remain the same as the indications for the current Scorpio® CR inserts. These are:
- 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 .
2
510(k) Summary Scorpio® CR SuperflexTM Tibial Inserts
Performance Data
Static testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts.
Statement of Technological Comparison
The fundamental scientific technology of the current Scorpio® CR tibial inserts has not changed with regard to the modified inserts. The modified inserts employ the same basic design concepts, the same materials, and the same manufacturing methods.
3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with three wavy lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2001
Ms. Mary-Catherine Dillon Regulatory Affairs Team Member Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
Re: K011643
Trade Name: Scorpio® Cruciate Retaining (CR) Superflex™ Tibial Inserts Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: May 25, 2001 Received: May 29, 2001
Dear Ms. Dillon:
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 sured in the encreater) to 'cal Device Amendments, or to devices that have been reclassified in encerdance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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 action. In addition, FDA may publish further announcements 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. 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.
4
Page 2 - Ms. Mary-Catherine Dillon
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your dones contact the Office of Compliance at variance at additionally 809.10 for m Viro diagnosus on the promotion and advertising of your device, (301) 594-4659. Addinonally, for questions of the presence the regulation prease contact the Onlive or Comphanee as (st a station" (21 CFR 807.97). Other generall entitled, "Misuranding by releited to prema Act may be obtained from the Division of Small
information on your responsibilities under the Act 12012 142, 6507, and title information on your responsionnes and its not no not (300) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
itchell MDfor
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
5
510(k) Number (if known): Koll643
Device Name: Scorpio® CR Superflex™ Tibial Inserts
The Scorpio® CR Superflex™ Tibial Bearing Inserts are single use devices. They are intended for mating with commercially available Howmedica Osteonics tibial trays and patellas and Scorpio® Total Knee CR femoral components, which are intended for cemented fixation.
Indications
The indications for the modified Scorpio® CR Superflex™ tibial inserts will remain the same as the indications for the current Scorpio® CR inserts. These are:
- 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 .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Per 21 CFR |
(Optional Format 1-2-96)
Dsmichell, MD
onmul
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K011643 |
|---|---|
| --------------- | --------- |