(107 days)
P.F.C.® Sigma Knee System
Not Found
No
The 510(k) summary describes a mechanical knee replacement system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is a prosthetic knee system intended to replace the natural knee joint to alleviate severe pain and disability caused by various forms of arthritis, which is a therapeutic purpose.
No
The device is described as a "prosthetic device intended to replace the natural knee joint," indicating it is a treatment device, not a diagnostic one.
No
The device description clearly lists physical components (Femoral components, Tibial inserts, Femoral augmentation pieces, Tibial Wedges) made of materials like UHMWPE, Titanium, and Co-Cr-Mo alloy, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a prosthetic device to replace a damaged knee joint. This is a surgical implant, not a test performed on biological samples outside the body.
- Device Description: The description details the physical components of a knee implant (femoral components, tibial inserts, etc.) made of materials like UHMWPE, Titanium, and Co-Cr-Mo alloy. These are materials used for implants, not for diagnostic reagents or instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant for surgical replacement.
N/A
Intended Use / Indications for Use
The P.F.C.® Sigma Knee System (Size 1.5) 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 surqical intervention.
Product codes
JWH
Device Description
The P.F.C. ® Sigma Knee System (Size 1.5) consists of:
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- Femoral components with an asymmetric trochlear groove;
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- Tibial inserts or All-Polyethylene Tibiae;
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- Femoral augmentation pieces;
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- Tibial Wedges.
The device is a prosthetic device intended to replace the natural knee joint. The device is constructed of UHMWPE, Titanium and Co-Cr-Mo alloy.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were conducted for a determination of substantial equivalence: Constraint Testing Contact Areas/Contact Stress between all Interfacing Components Surface Characteristics of Articulating Surfaces Tibial Insert/Tibial Tray Interlock Testing Lateral Stability of Patellofemoral Joint
All testing concluded the device performed as well or better that the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
P.F.C.® Sigma Knee System
Reference Device(s)
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
Johnson&Johnson
PROFESSIONAL, INC.
510(k) Summary
K971189
JUL 17 1997
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person: John D. Ferros Phone:(508) 880-8287 Fax: (508) 828-3212
Name of Device
Classification Name: Knee joint patellofemorotibial 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 (Size 1.5)
Performance Standards: No performance standards have been developed as yet for this device.
Predicate Device
P.F.C.® Sigma Knee System
Description of Device
The P.F.C. ® Sigma Knee System (Size 1.5) consists of:
-
- Femoral components with an asymmetric trochlear groove;
-
- Tibial inserts or All-Polyethylene Tibiae;
-
- Femoral augmentation pieces;
-
- Tibial Wedges.
The device is a prosthetic device intended to replace the natural knee joint. The device is constructed of UHMWPE, Titanium and Co-Cr-Mo alloy.
Intended Use
The P.F.C.® Sigma Knee System (Size 1.5) 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 surqical intervention.
Technological Characteristics Compared to Predicate Device
All the components of the P.F.C.® Sigma Knee System (Size 1.5) are identical to the components of the previously cleared P.F.C.® Sigma Knee System, except they are designed in a smaller size. All materials used in the P.F.C.® Sigma Knee System (Size 1.5) are also identical to the P.F.C.® Sigma Knee System.
Performance Tests
The following tests were conducted for a determination of substantial equivalence: Constraint Testing Contact Areas/Contact Stress between all Interfacing Components Surface Characteristics of Articulating Surfaces Tibial Insert/Tibial Tray Interlock Testing Lateral Stability of Patellofemoral Joint
All testing concluded the device performed as well or better that the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
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 1 7 1997
Re: K971189 P.F.C. Σ Sigma Knee System (Size 1.5) Regulatory Class: II Product Code: JWH Dated: June 30, 1997 Received: July 2, 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:
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- This device may not be labeled or promoted for non-cemented use.
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- All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
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Page 2 - Mr. John D. Ferros
- 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 Regulations, Title 21, Parts 800 to 895. ਸ 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 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 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,
Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: P.F.C. Sigma Knee System (Size 1.5)
Indications for Use:
The P.F.C. Sigma Knee System (Size 1.5) 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)
PCOSEE
(Division Sign-Off) Division of General Restorative Devices 510(k) Number Ka 1189
Prescription Use X (Per 21 CFR 801.109)
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)