(43 days)
Not Found
No
The document describes a mechanical implant (tibial baseplate) and its modifications, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
This device is a total knee component indicated for conditions like arthritis and failed previous replacements, which are conditions that involve the treatment or mitigation of disease.
No
This device is a total knee component (tibial baseplate), which is an implant used for joint replacement surgery, not for diagnosing conditions.
No
The device description clearly states the device is a physical implant (tibial baseplate) made of Ti-6Al-4V material with porous and HA coatings. It is a hardware component intended for surgical implantation.
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.
- Device Description: The provided text describes a total knee component, specifically a tibial baseplate, which is an implantable device used in knee replacement surgery.
- Intended Use: The intended use clearly states the device is for treating conditions like arthritis and failed previous surgeries, all of which involve surgical implantation and not the analysis of bodily specimens.
The device described is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
Total knee components are indicated for:
- Rheumatoid arthritis
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.
Product codes (comma separated list FDA assigned to the subject device)
MBH
Device Description
Subject of this premarket notification is a review of changes to the Profix Porous Tibial Baseplates (previously cleared for market via premarket notification K030623) to result in the Legion Porous + HA Tibial Baseplates. The subject devices are uncemented tibial baseplates manufactured from Ti-6Al-4V material and feature a porous coating of CP Ti beads and an HA coating. The devices will be available in left and right configurations in sizes 2 through 8.
When compared to the predicate Profix Porous Tibial Baseplates, the Legion Porous + HA Tibial Baseplates have been modified as follows:
- 0 Utilization of the Genesis II style periphery, profile, and locking detail
- . Addition of HA coating
- 트 Increase in thickness of baseplate
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
Older patients
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)
Design verification testing has been performed based on requirements outlined in FDA's Class 2 Special Controls Guidance Document Knee Joint Patellofemoratibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and Staff, dated January 16, 2003 and Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components dated May 1, 1995. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.
Clinical data was not needed to support the safety and effectiveness of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K(∞89 7
Summary of Safety and Effectiveness LEGION Porous + HA Tibial Baseplates Smith & Nephew, Inc.
Contact Person and Address Megan Bevill Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 T (901) 399-5340
Date of Summary: April 14, 2010
MAY 1 3 2010
Name of Device: Legion Porous + HA Tibial Baseplate Common Name: Total Knee Prosthesis Device Classification Name and Reference: 21 CFR 888.3565 Knee joint patellofemorotibial metal/polymer porous coated uncemented prosthesis Device Class: Class II Panel Code: Orthopaedics/87 MBH
Device Description
Subject of this premarket notification is a review of changes to the Profix Porous Tibial Baseplates (previously cleared for market via premarket notification K030623) to result in the Legion Porous + HA Tibial Baseplates. The subject devices are uncemented tibial baseplates manufactured from Ti-6Al-4V material and feature a porous coating of CP Ti beads and an HA coating. The devices will be available in left and right configurations in sizes 2 through 8.
When compared to the predicate Profix Porous Tibial Baseplates, the Legion Porous + HA Tibial Baseplates have been modified as follows:
- 0 Utilization of the Genesis II style periphery, profile, and locking detail
- . Addition of HA coating
- 트 Increase in thickness of baseplate
Intended Use
Total knee components are indicated for:
-
- Rheumatoid arthritis
-
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- এ. The posterior-stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.
1
Summary of Safety and Effectiveness LEGION Porous + HA Tibial Baseplates Smith & Nephew, Inc.
Performance Data
Design verification testing has been performed based on requirements outlined in FDA's Class 2 Special Controls Guidance Document Knee Joint Patellofemoratibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and Staff, dated January 16, 2003 and Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components dated May 1, 1995. A review of the testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.
Clinical data was not needed to support the safety and effectiveness of the subject device.
Substantial Equivalence Information
The Legion Porous + HA Tibial Baseplates are substantially equivalent to previously cleared devices listed below. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate knee systems.
| Description | 510(k) | Clearance Date |
|---|---|---|
| Profix Total Knee System | K030623 | 5/22/03 |
| Genesis II Porous + HA Knee System | K032683 | 10/15/03 |
Table 1. Predicate knee systems
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the Legion Porous + HA Tibial Baseplates. Based on the similarities to the predicate devices and a review of the testing, the devices are substantially equivalent to knee components currently marketed under K030623 and K032683.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Orthopaedic Division Ms. Megan Bevill Regulatory Affairs Specialist 1450 E. Brooks Road Memphis, Tennessee 38116
MAY 1 3 2010
Re: K100897
Trade/Device Name: Legion Porous + HA Tibial Baseplates Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: April 14, 2010 Received: April 15, 2010
Dear Ms. Bevill:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Ms. Megan Bevill
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Barbara Buechner
Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _
Device Name: Legion Porous + HA Tibial Baseplate
Total knee components are indicated for:
- ﺒﺴﺘ Rheumatoid arthritis
-
- Post-traumatic arthrilis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
-
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior-stabilized knee system is designed for use in patients in primary and revision 4. surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Legion Porous + HA Tibial Baseplates are indicated for use without bone cement, and are single use devices.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart Cl
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Omitted for nxm
(Claim Signed)
Division of Surgical and Restorative Devices
510(k) Number K100897