(71 days)
Not Found
Not Found
No
The summary describes a knee implant and does not mention any AI or ML components or functionalities.
Yes.
The device is indicated for use in patients suffering from severe pain and disability due to permanent structural damage resulting from various medical conditions, indicating a therapeutic purpose to alleviate symptoms and improve function.
No
The device description clearly states it is a "patellar prosthesis intended for use in Total Knee Replacement," which is a treatment, not a diagnostic tool.
No
The device description clearly states it is a patellar prosthesis constructed of UHMWPE, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a patellar prosthesis (an artificial knee cap) intended for use in Total Knee Replacement surgery. This is a surgically implanted device used to replace a damaged anatomical structure.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens taken from the patient. Its function is to replace a part of the knee joint.
Therefore, based on the provided information, the P.F.C. Sigma Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The P.F.C. Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
Product codes
JWH
Device Description
The P.F.C. Sigma Inset Patella is a patellar prosthesis intended for use in Total Knee Replacement. The device is constructed of UHMWPE.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
P.F.C.® Σ Oval Dome Patella, Universal Inset Patella
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.
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Johnson & Johnson Professional, Inc. 325 Paramount Drive Ravnham. MA 02767-0350
Contact Person: John Ferros Phone: 508.880.8287
Name of Device
Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis has been placed in Class II by the FDA under 21 CFR 888.3560. This falls under the Orthopaedics panel/87. Common Name: Semi-constrained total knee prosthesis.
Trade Name/Proprietary Name: P.F.C. Sigma Knee System Inset Patella
Performance Standards: No performance standards have been developed for this device.
Predicate Device
P.F.C.® Σ Oval Dome Patella, Universal Inset Patella
Description of Device
The P.F.C. Sigma Inset Patella is a patellar prosthesis intended for use in Total Knee Replacement. The device is constructed of UHMWPE.
Intended Use
The P.F.C.® Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis,
osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
Technological Characteristics Compared to Predicate Device
| | P.F.C. Σ
Inset Patella
(subject of this submission) | P.F.C. Σ
Oval-Dome Patella
K961685 | Universal
Inset Patella
K933867 |
|------------------------------------|-----------------------------------------------------------|------------------------------------------|---------------------------------------|
| Design | | | |
| Bone Removal | reamed cavity | planar resection | reamed cavity |
| Bone Periphery @ Major
Diameter | yes | no | yes |
| Articulating Surface | 1" spherical radius¹ | 1" spherical radius¹ | 0.8" spherical radius² |
| Cement Pocket Geometry | Dovetail Undercut | Dovetail Undercut | Dovetail Undercut |
| Peg Geometry(ies) | Round & Clover | Round | Round |
| Material | UHMWPE | UHMWPE | UHMWPE |
Exactly matches the PFC® Σ Femur (C/R, C/S & TC3) Patellar Grooves 1.
Approximately matches the PFC® C/R Femur Patellar Groove 2.
Image /page/0/Picture/20 description: The image shows the number 10 written in a handwritten style. The number is written in black ink on a white background. The number is slightly tilted to the left.
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Image /page/1/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John D. Ferros Senior Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
JUL 16 1997
Re : K971652 P.F.C.® Σ (Sigma) Inset Patella Requlatory Class: II Product Code: JWH Dated: May 5, 1997 Received: May 6, 1997
Dear Mr. Ferros:
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 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). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:
-
- This device may not be labeled or promoted for non-cemented use.
- All labeling for this device, including package 2. label and labeling included within the package, must prominently state that the device is intended for cemented use only.
2
- Any non-cemented fixation of this device is 3. considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for non-cemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
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Page 3 - Mr. John D. Ferros
If you desire specific advice for your device on our labeling regulation (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.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: P.F.C. Sigma Knee System Inset Patella
Indications for Use:
The P.F.C. Sigma Knee System is indicated for use only with bone cement (PMMA) for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders or pseudogout. This damage may also be the result of trauma or failed prior surgical intervention.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of General Restorative Devices 510(k) Number
Prescription Use _x (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)