(70 days)
No
The 510(k) summary describes a mechanical knee implant component and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is a knee implant designed for joint replacement, which is a structural component of a surgical procedure, not a device that directly administers therapy.
No
The device is a component of a total knee replacement system, used to treat existing conditions rather than diagnose them.
No
The device description clearly states it is a "titanium tibial tray component," which is a physical implant used in knee replacement surgery. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a component of a total knee replacement system used to treat patients with severe pain and disability due to structural damage in the knee joint. This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details a titanium tibial tray component designed to be implanted in the knee. This is a physical medical device for surgical use.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests outside the body, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a therapeutic device used in the body to replace a damaged joint.
N/A
Intended Use / Indications for Use
"The P.F.C. Modular Total Knee System is indicated for use in a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint 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.
The P.F.C. ® Modular Plus Offset Tibial Tray is indicated for use with polymethylmethacrylate (PMMA) bone cement."
Product codes
87 JWH
Device Description
"The P.F.C. Modular Plus Offset Tibial Tray is part of a modular system for use in total knee replacement. The subject device is a titanium tibial tray component, which is designed to accept snap-in tibial inserts in a range of thicknesses and a variety of surface topographies.
The P.F.C. Modular Plus Offset Tibial Tray and its parent device, the P.F.C. Modular Plus Tibial Tray (K923807) have the same keel geometry and adjusted cement pockets that accommodate four screw holes for optional wedge attachment.
The P.F.C. Modular Plus Offset Tibial Tray has been designed with a proximal baseplate offset from the central stem to accommodate patients whose anatomic canal is not centered within the tibia."
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K884796, K892394, K923807, K960279
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
510(k) Summary of Safety and Effectiveness
P.F.C.® Modular Plus Offset Tibial Tray
Manufacturer: Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350
A. Contact Person:
Arlene C. Saull, RAC Sr. Submissions Associate DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581-0988 (219) 372-7276
B. Device Information:
| Proprietary Name: | P.F.C.® Modular Plus Offset Tibial Tray |
|---|---|
| Common Name: | Total Knee Prosthesis Tibial Tray Component |
| Classification Name: | Knee joint Patellofemorotibial polymer/metal/ |
| polymer semi-constrained cemented prosthesis | |
| Regulatory Class: | Class II, per 21 §CFR 888.3560 |
| Product Code: | 87 JWH |
C. Indications for Use:
The P.F.C. Modular Total Knee System is indicated for use in a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint 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.
The P.F.C. ® Modular Plus Offset Tibial Tray is indicated for use with polymethylmethacrylate (PMMA) bone cement.
0000000
1
D. Device Description:
The P.F.C. Modular Plus Offset Tibial Tray is part of a modular system for use in total knee replacement. The subject device is a titanium tibial tray component, which is designed to accept snap-in tibial inserts in a range of thicknesses and a variety of surface topographies.
The P.F.C. Modular Plus Offset Tibial Tray and its parent device, the P.F.C. Modular Plus Tibial Tray (K923807) have the same keel geometry and adjusted cement pockets that accommodate four screw holes for optional wedge attachment.
The P.F.C. Modular Plus Offset Tibial Tray has been designed with a proximal baseplate offset from the central stem to accommodate patients whose anatomic canal is not centered within the tibia.
E. Substantial Equivalence:
The P.F.C. 8 Modular Plus Offset Tibial Tray is similar in performance, intended use, materials, design, performance characteristics, packaging, and sterilization method to the P.F.C.® Modular Tibial Tray (K884796 and K892394), the P.F.C.® Modular Plus Tibial Tray (K923807), and the Zimmer NexGen® LCCK Knee System (K960279).
The determination of substantial equivalence for this device is based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ASTM F136 and the FDA "Draft Guidance for the Preparation of Premarket Notifications {510(k)s} for Cemented, Semi-Constrained Total Knee Prostheses."
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three horizontal lines above them, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1999
Arlene C. Saull, RAC Senior Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re : K984158 P.F.C® Modular Plus Offset Tibial Tray Regulatory Class: II Product Code: JWH November 18, 1998 Dated: Received: November 19, 1998
Dear Ms. Saull:
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 This decision is based on Food, Drug, and Cosmetic Act (Act). 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-1. cemented use.
-
- 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.
-
- Any non-cemented fixation of this device is 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 noncemented fixation must receive approval from their
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Page 2 - Arlene C. Saull, RAC
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. 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 Administration (FDA) will verify such assumptions. Failure to 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.
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 leqally marketed predicate device results in a classification for your device and 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
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Page 3 - Arlene C. Saull, RAC
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,
Ceia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
K984158 510(k) Number (if known) Device Name P.F.C.® Modular Plus Offset Tibial Tray
Indications For Use
The P.F.C. Modular Total Knee System is indicated for use as a total knee replacement for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, or pseudogout.
This damage may also be a result of trauma or failed prior surgical intervention.
The P.F.C. ® Modular Plus Offset Tibial Tray is indicated for use with polymethylmethacrylate (PMMA) bone cement.
(Please do not write below this line - continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acoea
Prescription Use (Per 21 CFR §801.109)
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________