(74 days)
Not Found
No
The 510(k) summary describes a mechanical implant (tibial tray) and makes no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The description focuses on the material and design, referencing a predicate device from 1994.
Yes.
The device is used in total knee replacement surgery to address permanent structural damage from various conditions, aiming to alleviate severe pain and disability, which aligns with the definition of a therapeutic device.
No
Explanation: This device is a surgical implant (tibial tray for knee replacement), not a device used to diagnose medical conditions.
No
The device description explicitly states the device is a "Co-Cr-Mo alloy tibial tray," which is a physical hardware component used in knee replacement surgery.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Sigma Co-Cr Tibial Trays are physical implants used in total knee replacement surgery. They are surgically placed within the body.
- Intended Use: The intended use is to replace damaged knee joints, not to diagnose a condition using a sample from the body.
This device is a surgical implant or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
The Sigma Co-Cr Tibial Trays are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The Sigma Co-Cr Tibial Trays are intended for cemented use only.
Product codes
87 JWH
Device Description
The DePuy Sigma Co-Cr Tibial Trays are Co-Cr-Mo alloy tibial trays similar in design to the Darwin tibial trays cleared in K943462. The Sigma Co-Cr Tibial Trays are intended for use with the Darwin (now PFC Sigma) femoral and patella components, previously cleared in K943462.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
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
032151
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SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl Hastings
Director, Regulatory Affairs |
| TRADE NAME: | DePuy Sigma Co-Cr Tibial Trays |
| COMMON NAME: | Total Knee Joint Replacement Prosthesis |
| CLASSIFICATION: | 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis; Class II |
| DEVICE PRODUCT CODE: | 87 JWH |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | Johnson & Johnson Professional, Inc. (now DePuy)
Darwin Knee System - K943462 |
DEVICE DESCRIPTION:
The DePuy Sigma Co-Cr Tibial Trays are Co-Cr-Mo alloy tibial trays similar in design to the Darwin tibial trays cleared in K943462. The Sigma Co-Cr Tibial Trays are intended for use with the Darwin (now PFC Sigma) femoral and patella components, previously cleared in K943462.
INTENDED USE AND INDICATIONS:
The Sigma Co-Cr Tibial Trays are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The Sigma Co-Cr Tibial Trays are intended for cemented use only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Sigma Co-Cr Tibial Trays have the same basic design and the same intended use as the tibial trays of the Darwin Knee System. Like the Darwin trays, the Sigma Co-Cr trays can be used with the existing PFC Sigma femoral and patella components. The tibial tray material has been changed from forged Ti-6Al-4V alloy to forged Co-Cr-Mo alloy. Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the Sigma Co-Cr Tibial Trays are substantially equivalent to the previously cleared trays of the Darwin Knee System.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
SEP 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cheryl Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw. Indiana 46581-0988
Re: K032151
Trade/Device Name: DePuy Sigma Co-Cr Tibial Trays Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: August 27, 2003 Received: August 28, 2003
Dear Ms. Hastings:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 vours,
Sincerely yours,
Mark N Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications Statement
510(k) Number (if known) K032151
Device Name DePuy Sigma Co-Cr Tibial Trays
Intended Use and Indications:
The Sigma Co-Cr Tibial Trays are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The Sigma Co-Cr Tibial Trays are intended for cemented use only.
Concurrence of CDRH, Office of Device Evaluation
for Mark N. Millican
Tivision Sign-Off) Latision of General, Restorative and Neurological Devices Kossalis
510(k) Number_
Prescription Use _ (Per 21 CFR 801.109) OR
Over-The Counter Use