(24 days)
K040281, Not Found
No
The summary describes a mechanical knee prosthesis component and its intended use, with no mention of AI or ML technology.
No
The device, a knee prosthesis, is used in surgical intervention to treat pain and disability caused by diseases or trauma. Surgical tools or implants are not typically considered therapeutic devices.
No
This device is a total knee prosthesis and related adapters, intended for structural replacement in total knee replacement surgery. It is not described as being used for diagnosis or detection.
No
The device description clearly states it consists of physical components (adapters and bolts) intended for surgical implantation, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage." This describes a surgical implant used in vivo (within the body) to replace a damaged joint.
- Device Description: The description details components that attach to a femoral component of a knee prosthesis, providing fixation extensions. This is consistent with a surgical implant.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does none of those things.
The information provided describes a surgical implant used directly in a patient's body during a surgical procedure.
N/A
Intended Use / Indications for Use
The PFC® Sigma Total Knee Prosthesis is 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 PFC Sigma Total Knee Prosthesis is intended for cemented use only.
Product codes
JWH
Device Description
The DePuy Sigma Femoral Adapters are a modification to the previously cleared DePuy PFC Sigma Femoral Adapters included in K040281. The devices consist of a selection of adapters and bolts that attach to Sigma TC3 and C/S femoral components' intracondylar boxes. When assembled to a femoral component, they provide a construct for the attachment of additional fixation extensions such as metaphyseal sleeves or cemented and fluted stem extensions. The Sigma Femoral Adapters are available in five and neveous degree valgus angle options and +2 mm, 0 mm, and -- 2 mm anterior/posterior offset options.
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)
Based upon the similarities in the design, the equivalent materials utilized and the results from the mechanical testing of the PFC Sigma Femoral Adapter, DePuy believes this device to be substantially equivalent to other commercially available devices.
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.
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K060515 Page 1 of 2
MAR 2 3 2006
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
EST REG No.: 1818910 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Steve Wentworth
Regulatory Affairs Manager
Tel: (574) 371-4913
Fax: (574) 371-4987 |
| TRADE NAME:
COMMON NAME: | DePuy PFC® Sigma Knee Prosthesis
Tricompartmental Knee Prosthesis |
| CLASSIFICATION: | Knee joint patellofemorotibial, polymer/metal/polymer semi-
constrained cemented prosthesis (21 CFR 888.3560), Class II Device |
| DEVICE PRODUCT CODE: | JWH |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | DePuy LPS Metaphyseal Sleeve Component
(K040281, cleared July 9, 2004)
Darwin Knee System (TC3)
(K952830, cleared January 18, 1996) |
DEVICE DESCRIPTION:
The DePuy Sigma Femoral Adapters are a modification to the previously cleared DePuy PFC Sigma Femoral Adapters included in K040281. The devices consist of a selection of adapters and bolts that attach to Sigma TC3 and C/S femoral components' intracondylar boxes. When assembled to a femoral component, they provide a construct for the attachment of additional fixation extensions such as metaphyseal sleeves or cemented and fluted stem extensions. The Sigma Femoral Adapters are available in five and neveous degree valgus angle options and +2 mm, 0 mm, and -- 2 mm anterior/posterior offset options.
INDICATIONS FOR USE:
The PFC® Sigma Total Knee Prosthesis is intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to nermanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The PFC Sigma Total Knee Prosthesis is intended for cemented use only.
00000000
1
BASIS FOR SUBSTANTIAL EQUIVALENCE:
The design of the PFC Sigma Knee Prosthesis Femoral Adapter is substantially equivalent to the LPS Metaphyseal Sleeve (K040281) and the Darwin Knee System (TC3) (K952830). The materials used for the subject device components are identical to those for the predicated devices and the design of the attachment mechanism incorporates similar adapter, retaining ring and bolt components. The available offset options (2mm anterior, neutral, 2mm posterior) are the same for the PFC Sigma and the predicate devices. Both the PFC Sigma and Darwin Knee systems offer S and 7 valgus angle components, whereas the LPS system offers only a 5° valgus angle component.
Based upon the similarities in the design, the equivalent materials utilized and the results from the mechanical testing of the PFC Sigma Femoral Adapter, DePuy believes this device to be substantially equivalent to other commercially available devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human figures within its body, representing the department's focus on health and human well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2006
DePuy Orthopaedics, Inc. c/o Mr. Steven J. Wentworth Regulatory Affairs Project Manager P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K060515
Trade/Device Name: DePuy Sigma Knee Femoral Adapter 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: February 24, 2006 Received: February 27, 2006
Dear Mr. Wentworth:
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 I'DA'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
3
Page 2 - Mr. Steven J. Wentworth
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. 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 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.
Hukut Lumur 09
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: DePuy Sigma Knce Femoral Adapter
Intended Use and Indications:
The PFC® Sigma Total Knee Prosthesis is 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 PFC Sigma Total Knee Prosthesis is intended for cemented use only.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-6 Division of General, Restorative and Neurological Devices
510(k) Number Kol060515
0000008