(30 days)
No
The document describes a mechanical knee implant component and does not mention any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is a knee implant used in total knee replacement surgery to correct functional deformity and treat various degenerative joint diseases and injuries. This directly addresses health conditions and restores function, which are characteristics of a therapeutic device.
No
The device is a patellar component for knee replacement surgery, which is a therapeutic intervention, not a diagnostic one. Its intended use focuses on correcting functional deformities and replacing damaged knee anatomy.
No
The device description clearly states it is a "single use component" and a "Patellar Component," which are physical hardware components used in knee replacement surgery. There is no mention of software.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant intended for use in total knee replacement surgery. It is a physical component (a patellar component) that is surgically implanted into the knee joint.
- Lack of Diagnostic Function: The device does not perform any tests on bodily samples to diagnose a condition or provide information about a patient's health status through analysis of those samples. Its function is purely mechanical and structural within the knee joint.
Therefore, based on the provided information, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The subject devices are single use components, intended for cemented use only. They are intended for use in conjunction with associated Duracon femoral components as part of cemented total knee replacement surgery. Indications for use, in keeping with those of other commercially-available, Class II total knee devices, are as follows:
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
- Revision procedures where other treatments have failed.
- Post-traumatic loss of knee joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy.
- Irreparable fracture of the knee.
Product codes
JWH
Device Description
The subject 25mm Duracon Inset Patellar Component is identical to the commercially-available Duracon Inset Patellar Components (available in sizes 27, 29, 31, and 33mm), except for its smaller diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (Patellar)
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)
Comparative testing (simulated chair rising and stair climbing) confirmed that the wear resistance of the modified component is not significantly different from that of existing product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
DEC = 2 1999 510(k) Summary
Duracon Inset Patellar Component: Additional Size
Submission Information
| Name and Address of the Sponsor: | Howmedica Osteonics Corp.
59 Route 17
Allendale, NJ 07401-1677 |
|----------------------------------|----------------------------------------------------------------------|
| Contact Person: | Terry Sheridan Powell |
| Date of Summary Preparation: | October 29, 1999 |
Device Identification
Proprietary Name: Duracon Inset Patellar Component Common Name: Artificial Knee Component
Classification Name and Reference:
888.3560: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Predicate Device Identification
The Duracon Inset Patellar Component, in sizes 27, 29, 31, and 33mm, were determined Substantially Equivalent via 510(k) #K961482. They were then cleared in a Duration-stabilized version via K965173. This Special 510(k) covers an additional size component: 25mm.
1
The intended use of the subject component is unchanged from that of the commercially-available Duracon Inset Patellar Components. The indications are specified in the Indications for Use attachment, and are the same as those cleared via K961482.
Device Description
The subject 25mm Duracon Inset Patellar Component is identical to the commercially-available Duracon Inset Patellar Components (available in sizes 27, 29, 31, and 33mm), except for its smaller diameter.
Statement of Technological Comparison
The materials for the subject and predicate devices are identical. The indications for use of the subject and predicate devices are identical. The design of the subject and predicate devices is the same, except that the subject device is a new, smaller size: 25mm diameter. The performance testing is sufficient to demonstrate that the subject and predicate devices are Substantially Equivalent with regard to design.
Performance Data
Comparative testing (simulated chair rising and stair climbing) confirmed that the wear resistance of the modified component is not significantly different from that of existing product.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 1999
Ms. Terry Sheridan Powell Regulatory Affairs Department Howmedica Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
Re: K993692 Duracon Inset Patella, 25mm Trade Name: Regulatory Class: II Product Code: JWH Dated: October 29, 1999 Received: November 2, 1999
Dear Ms. Powell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the action ially 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 redical boundance 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 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 General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. 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 requlations.
3
Page 2 - Ms. Terry Sheridan Powell
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.qov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.R. Ogden
James F. Dillard III
James E. Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K_993692
Device Name: Duracon Inset Patellar Component, Additional Size (25mm)
Indications For Use:
The subject devices are single use components, intended for cemented use only. They are intended for use in conjunction with associated Duracon femoral components as part of cemented total knee replacement surgery. Indications for use, in keeping with those of other commercially-available, Class II total knee devices, are as follows:
- . Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis.
- Rheumatoid arthritis. .
- . Correction of functional deformity.
- . Revision procedures where other treatments have failed.
- . Post-traumatic loss of knee joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy.
- . Irreparable fracture of the knee.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| ARO for | |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K993692 |
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use ________
(Optional Format 1-2-96)