(22 days)
P830055, K933787
No
The document describes a mechanical knee replacement component and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device replaces a damaged knee joint to provide increased patient mobility and reduced pain, which are therapeutic benefits.
No
Explanation: The device described is a femoral component for a total knee replacement system, which is an implant used for treatment/repair rather than for diagnosing a condition.
No
The device description clearly states it is a physical femoral component made of Co-Cr, intended for surgical implantation as part of a total knee replacement system. 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant – a femoral component for a total knee replacement. This device is physically implanted into the patient's body to replace a damaged joint.
- Intended Use: The intended use is to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a medical device, but it falls under the category of implantable devices or surgical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Sigma C/R Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system.
Total Knee Replacement is intended to provide increased patient 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 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 significant improvement in their quality of life.
Product codes
JWH, MBH
Device Description
The Sigma C/R Porocoat Femoral Components are part of the Sigma Total Knee Replacement System. They are porous coated Co-Cr femoral components with an asymmetric trochlear groove, available in sizes 1.5- 6, in right and left versions. Fixation of the femoral component to the femur is achieved using either bone cement or by biologic fixation via tissue ingrowth into the porous coating.
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)
Reference Device(s)
P830055, K933787
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
SEP 2 9 2006
510(k) SUMMARY
| NAME OF FIRM: | DePuy Orthopaedics Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Establishment Registration No.: 1818910 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Nancy Friddle
Team Leader, Regulatory Affairs
Tel: (574) 371-4923
Email: nfriddle@dpyus.jnj.com |
| TRADE NAME: | DePuy Sigma Cruciate Retaining (C/R)
Porocoat® Femoral Components |
| COMMON NAME: | Total Knee Replacement Prosthesis |
| CLASSIFICATIONS: | 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained
cemented prosthesis; Class II
888.3565 Knee joint patellofemorotibial
polymer/metal porous coated uncemented
prosthesis; Class II |
| DEVICE PRODUCT CODES: | JWH, MBH |
| SUBSTANTIALLY EQUIVALENT
DEVICES: | PFC Sigma® Knee System (cleared as Darwin
Knee System), K943462
PFC Cruciate Retaining Knee System, Size 1.5
K961685
AML® Proximally Coated Hip, K933787 |
DEVICE DESCRIPTION:
The Sigma C/R Porocoat Femoral Components are part of the Sigma Total Knee Replacement System. They are porous coated Co-Cr femoral components with an asymmetric trochlear groove, available in sizes 1.5- 6, in right and left versions. Fixation of the femoral component to the femur is achieved using either bone cement or by biologic fixation via tissue ingrowth into the porous coating.
INDICATIONS FOR USE:
The Sigma C/R Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system.
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Total Knee Replacement is intended to provide increased patient mobility and reduced pain bv 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 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 significant improvement in their quality of life.
SUBSTANTIAL EQUIVALENCE
The Sigma C/R Porocoat Femoral Components are identical in design to the Sigma Femoral Components cleared for cemented use only in K943462 and K961685. The Porocoat porous coating of the Sigma C/R Porocoat Femoral Components is identical to the Porocoat porous coating used on the LCS Knee Femoral Components, which were approved for cementless use in P830055 and on the AML Proximally Coated Hip cleared for cementless use in K933787.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle-like symbol with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2006
DePuy Orthopaedics, Inc. % Ms. Nancy Friddle Team Leader, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K062654
Trade/Device Name: "DePay Sigma Cruciate Retaining Porocoat" Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: September 6, 2006 Received: September 7, 2006
Dear Ms. Friddle:
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 for about in 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, 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 (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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Nancy Friddle
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 (240) 276-0120. 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 will ber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
f
Mark N. Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K062654 510(k) Number (if known):
Device Name: DePuy Sigma Cruciate Retaining Porocoat® Femoral Components
Indications for Use:
The Sigma Cruciate Retaining Porocoat Femoral Components are intended for cemented or cementless use as the femoral components of a Total Knee Replacement system.
Total Knee Replacement is intended to provide increased patient 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 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 significant improvement in their quality of life.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)
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and Neurslogica
510(k) Number K062654
0000004