(156 days)
Not Found
No
The summary describes a knee implant component made of crosslinked polyethylene with improved wear properties, and there is no mention of AI or ML technology.
Yes
The device is a knee component indicated for various forms of arthritis and is designed for surgical implantation to improve joint function, which aligns with the definition of a therapeutic device.
No
The provided text describes knee components (implants) and their indications for use in surgical procedures, not devices used for diagnosis.
No
The device description clearly states it is a physical implant (articular inserts made of crosslinked polyethylene) for knee replacement surgery, 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, or tissue) to provide information about a person's health.
- Device Description: The provided text describes Total Knee components, specifically articular inserts made of crosslinked polyethylene. These are implants designed to be surgically placed within the knee joint.
- Intended Use: The intended use clearly states that these components are for surgical implantation in patients with various forms of arthritis.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis for use in primary and revision surgeries. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Constrained Knee Systems are designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the colateral ligaments (i.e. medial cruciate ligament and one or both of the collateral ligaments) are absent on inadequate. The indications for each device system are identical to the indications for each cleared predicate knee system.
Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis for use in primary and revision surgeries. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Constrained Knee Systems are designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the colateral ligaments (i.e. medial cruciate ligament and one or both of the collateral ligaments) are absent or inadequate. Smith & Nephew, Inc. Crosslinked Polyethylene Articular Inserts are single use devices. The indications for each device system are identical to the indications for each cleared predicate knee system
Product codes
JWH, MBH
Device Description
The intended use, base material, and design specifications of the Smith & Nephew Crosslinked Polyethylene articular inserts for the Journey and Genesis II knee systems are the same as subject identical components fabricated from conventional non-Crosslinked Ultra High Molecular Weight Polyethylene. The devices subject to this premarket notification have been Crosslinked by a proprietary process. As a result, the polymer is highly crosstinked with increased wear performance properties over traditional UHMWPE.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K951987, K030612, K962137, K032295, K041825, K042515
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
K07107/ page 142
Smith & Nephew, Inc. Summary of Safety and Effectiveness Crosslinked Polyethylene Articular Inserts
SEP 1 9 2007
Contact Person and Address
Date of Summary: 04/12/2007
Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 (901)399-6054
Name of Device: Crosslinked Polyethylene Articular Inserts Common Name: Articular Inserts
Device Description
The intended use, base material, and design specifications of the Smith & Nephew Crosslinked Polyethylene articular inserts for the Journey and Genesis II knee systems are the same as subject identical components fabricated from conventional non-Crosslinked Ultra High Molecular Weight Polyethylene. The devices subject to this premarket notification have been Crosslinked by a proprietary process. As a result, the polymer is highly crosstinked with increased wear performance properties over traditional UHMWPE.
Device Classification
21 CFR 888.3560 Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis - Class II
21 CFR 888.3565 Knee joint patellofemorotibial polymer semi-constrained uncemented prosthesis - Class II
Indications for Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis for use in primary and revision surgeries. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Constrained Knee Systems are designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the colateral ligaments (i.e. medial cruciate ligament and one or both of the collateral ligaments) are absent on inadequate. The indications for each device system are identical to the indications for each cleared predicate knee system.
1
:
Substantial Equivalence Information
The overall design and function of the Crosslinked components have not been changed over that of their identical counterparts manufactured from conventional UHMWPE listed in the table below
| DESCRIPTION | 510(K) | CLEARANCE DATE |
|---|---|---|
| Genesis II Knee System (cemented use) | K951987 | 8/22/95 |
| Genesis II Knee System (uncemented use) | K030612 | 5/27/03 |
| Genesis II Constrained Knee System | K962137 | 8/2/96 |
| Genesis II High Flex PS Articular Inserts | K032295 | 8/21/03 |
| Genesis II Deep Flex CR Articular Inserts | K041825 | 3/11/05 |
| High Performance Knee (Journey BCS) | K042515 | 3/14/05 |
:
:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Mr. Rishi Sinha Regulatory Affairs Specialist 1450 E. Brooks Road Memphis, Tennessee 38116
SEP 1 9 2007
Re: K071071
Trade/Device Name: Crosslinked Polyethylene Articular Inserts Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: August 24, 2007 Received: August 28, 2007
Dear Mr. Sinha:
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. 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.
3
Page 2 - Mr. Rishi Sinha
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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchu
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K071071
Device Name: Crosslinked Polyethylene Articular Inserts
Indications for Use:
Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis for use in primary and revision surgeries. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Constrained Knee Systems are designed for use in patients in primary and revision surgeries, where the posterior cruciate ligament and one or both of the colateral ligaments (i.e. medial cruciate ligament and one or both of the collateral ligaments) are absent or inadequate. Smith & Nephew, Inc. Crosslinked Polyethylene Articular Inserts are single use devices. The indications for each device system are identical to the indications for each cleared predicate knee system
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew Buehler
(Division Sign-Off)
Division of Gen and Neurological De Page 1 of _
510(k) Number K071071