(264 days)
Not Found
No
The document describes a mechanical implant (tibial tray) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is a knee prosthesis component intended to replace damaged knee joint articulation to provide increased mobility and reduced pain, which are therapeutic effects.
No
This device is a prosthetic implant for knee replacement, intended to treat rather than diagnose a medical condition.
No
The device description clearly states it is a physical implant manufactured from titanium alloy with a porous coating, designed for surgical implantation in the knee joint. It is a hardware device, not software.
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: The provided text describes a surgical implant – a component of a total knee replacement system. It is a physical device implanted into the body to replace a damaged joint.
- Intended Use: The intended use is to "provide increased mobility and reduced pain by replacing the damaged knee joint articulation." This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
Therefore, based on the provided information, the PFC Sigma Lugged Tibial Tray is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.
Caution: This knee prosthesis component is intended for cemented use only.
Product codes
87 JWH
Device Description
The PFC Sigma Lugged Tibial Tray is designed with four angled pegs to provide firm fixation and anti-rotational properties while preserving bone stock. It is manufactured from titanium alloy (Ti-6A1-4V) and the distal surface is coated with commercially pure titanium porous coating to enhance cement fixation. If additional fixation is required, the tibial tray is designed with one screw hole to accept a bone screw.
The PFC Sigma Lugged Tibial Tray is designed for use with both P.F.C. Modular and P.F.C. Sigma tibial inserts, including curved, posterior lipped and stabilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
elderly patients, younger patients
Intended User / Care Setting
surgeon
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 determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards, e.g. ASTM F-1580, and ASTM F1044.
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
JUN 1 9 2001
510(k) Summary PFC Sigma Lugged Tibial Tray
DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581
A. Contact Person:
Janet G. Johnson, RAC Group Leader, Regulatory Submissions (219) 371-4907
B. Device Information:
| Proprietary Name: | PFC Sigma Lugged Tibial Tray |
|---|---|
| Common Name: | Tibial Tray |
| 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 PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.
Caution: This knee prosthesis component is intended for cemented use only.
1
510(k) Summary (Continued) PFC Sigma Lugged Tibial Tray
D. Device Description:
The PFC Sigma Lugged Tibial Tray is designed with four angled pegs to provide firm fixation and anti-rotational properties while preserving bone stock. It is manufactured from titanium alloy (Ti-6A1-4V) and the distal surface is coated with commercially pure titanium porous coating to enhance cement fixation. If additional fixation is required, the tibial tray is designed with one screw hole to accept a bone screw.
The PFC Sigma Lugged Tibial Tray is designed for use with both P.F.C. Modular and P.F.C. Sigma tibial inserts, including curved, posterior lipped and stabilized.
E. Substantial Equivalence:
The PFC Sigma Lugged Tibial Tray is substantially equivalent in terms of intended use, materials, design, sterilization method, and packaging to the Trick Modular Knee Tibial Tray -Porous (K931054) and the P.F.C. Sigma Porous Modular Keel Tibial Tray (K991106).
The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards, e.g. ASTM F-1580, and ASTM F1044.
2
Public Health Service
Image /page/2/Picture/2 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 an eagle or bird in flight, composed of three curved lines.
JUN 1 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janet G. Johnson, RAC Group Leader, Regulatory Submissions Depuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K003026
Trade Name: PFC Sigma Lugged Tibial Tray Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: March 23, 2001 Received: March 26, 2001
Dear Ms. Johnson:
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 legally marketed predicate 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). 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 requirements, 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.
3
Page 2 - Ms. Janet G. Johnson, RAC
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 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
lelluror
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
4
510(k) Number (if known) Device Name
KOD 3026 PFC Sigma Lugged Tibial Tray
Indications for Use
The PFC Sigma Lugged Tibial Tray is intended to provide increased mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant. Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total unicondylar knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives.
Caution: This knee prosthesis component is intended for cemented use only.
(Please do not write below this line - Continue on another page if necessary)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mr. Mr. Mr. Mr. Mr. Mr. Mr. Mr. Mr. Mr.
(Division Sign-Off) Division of General, Restorative and Neurological Devices
OR
KOO 3026 510(k) Number _
Prescription Use X (Per 21 CFR §801.109)
Over-the-Counter Use
(Optional Format 1-2-96)