(23 days)
Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. 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. Smith & Nephew Legion Porous Primary femoral components are indicated for use without bone cement and are single use devices.
Subject of this premarket notification are the Legion Porous Primary femoral components, which are intended for uncemented applications. The Legion Porous Primary femoral components are offered in cruciate retaining (C/R) and posterior stabilizing (P/S) designs, both manufactured from Cobalt Chrome alloy material. The femoral components are available in sizes 1 through 8 in right and left configurations. The femoral components will porous coated using a -45/+60 titanjum bead layer conforming to ASTM F67.
This document is a 510(k) summary for the Smith & Nephew Legion Porous Primary Femoral Component. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission does not typically include detailed studies with acceptance criteria and device performance metrics in the same way a PMA (Premarket Approval) application would.
Instead, substantial equivalence is generally established through comparisons to legally marketed predicate devices, focusing on design, materials, indications for use, and technological characteristics. Performance data, if included, is often limited to bench testing or material property comparisons rather than clinical studies with human readers or specific performance metrics like sensitivity/specificity.
Therefore, many of the requested categories in your prompt will not be found in this 510(k) submission.
Here's an analysis based on the provided text, indicating where information is present or not applicable (N/A) for this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable to a 510(k) summary in the way described. A 510(k) aims to demonstrate substantial equivalence to a predicate device, rather than meeting specific performance acceptance criteria from a clinical trial. The "performance" here refers to demonstrating that the new device is as safe and effective as existing models through design similarities, material properties, and intended use.
The document states: "The overall design of the Legion Porous Primary Femoral Component is based on the existing Genesis II Knee System femoral components cleared under the premarket notifications listed below". This indicates that the established performance of the predicate devices implicitly serves as the "acceptance criteria" for the new device – if it's substantially equivalent in design and materials, it's assumed to perform similarly.
The document mentions that the femoral components will be "porous coated using a -45/+60 titanium bead layer conforming to ASTM F67". This is a material specification used to demonstrate equivalence in manufacturing and material properties, rather than a clinical performance metric.
2. Sample Size Used for the Test Set and Data Provenance
N/A. This 510(k) summary does not describe a clinical test set or study with human subjects for performance evaluation. It relies on demonstrating substantial equivalence to predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
N/A. As there is no clinical test set described in this 510(k) summary, there were no experts used to establish ground truth for such a set.
4. Adjudication Method for the Test Set
N/A. No clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This submission does not describe an MRMC comparative effectiveness study to assess improvement with AI assistance (as this is not an AI device).
6. Standalone Performance Study (Algorithm Only)
N/A. This is a medical device (knee implant), not an algorithm or AI system.
7. Type of Ground Truth Used
N/A. No clinical study for performance evaluation described. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices to which it is compared.
8. Sample Size for the Training Set
N/A. This device does not involve a training set as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
N/A. No training set as it is not an AI/ML algorithm.
Summary of 510(k) Approach for this Device:
The core of this 510(k) submission is to establish Substantial Equivalence (SE) to legally marketed predicate devices. The document directly states: "The overall design of the Legion Porous Primary Femoral Component is based on the existing Genesis II Knee System femoral components cleared under the premarket notifications listed below".
The predicate devices mentioned are:
- Genesis II Knee System (cemented use)
- Genesis II Knee System (uncemented use)
The demonstration of substantial equivalence is likely achieved through:
- Comparison of Indications for Use: The current device's indications are consistent with the predicate devices.
- Comparison of Technological Characteristics: This includes material (Cobalt Chrome alloy, porous coated with titanium bead layer conforming to ASTM F67), design (CR and PS designs, sizes 1-8), and overall function.
- Non-clinical (bench) testing: While not detailed in this summary, such submissions typically include non-clinical performance data (e.g., mechanical testing, wear testing, fatigue testing) to demonstrate that the new device performs as intended and is comparable to the predicate devices under simulated use conditions.
Conclusion:
This 510(k) summary for the Legion Porous Primary Femoral Component does not contain the detailed information about acceptance criteria, clinical study designs, human reader performance, or ground truth establishment that would be found in a Premarket Approval (PMA) application or a submission for an AI-powered diagnostic device. Its purpose is to demonstrate substantial equivalence to existing, legally marketed knee prosthesis systems, rather than to prove performance against novel acceptance criteria from a clinical trial.
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Smith & Nephew, Inc. Summary of Safety and Effectiveness Legion Porous Primary Femoral Component
Date of Summary: 11/19/2007
Contact Person and Address Rishi Sinha Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Reconstruction 1450 Brooks Road Memphis, TN 38116 (901)399-6054
Name of Device: Legion Porous Primary Common Name: Knee Prosthesis
DEC 2 0 2007
Device Description
Subject of this premarket notification are the Legion Porous Primary femoral components, which are intended for uncemented applications. The Legion Porous Primary femoral components are offered in cruciate retaining (C/R) and posterior stabilizing (P/S) designs, both manufactured from Cobalt Chrome alloy material. The femoral components are available in sizes 1 through 8 in right and left configurations. The femoral components will porous coated using a -45/+60 titanjum bead layer conforming to ASTM F67.
Device Classification
21 CFR 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis - Class II
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 level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. 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. Smith & Nephew Legion Porous Primary femoral components are indicated for use without bone cement and are single use devices.
Substantial Equivalence Information
The overall design of the Legion Porous Primary Femoral Component is based on the existing Genesis II Knee System femoral components cleared under the premarket notifications listed below:
| The new to the control of the may be and the comments of the many of the more of the comments of the comments of the comments of the comments of the comments of the commentsSUCH PRODUCTION OF DESCRIPTION OF HONOR CONSULTION OF1. BEAT PARTY CLASS PLAN BARRETT PRODUCT OF CLASS OF COLLECTION COLLECTION COLLEGEC REAL TACK THAMPECIAL CARRE, LAND AS BE | 1237 18484452521 1358 11111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111111A | was to the loss of the first |
|---|---|---|
| tenesis II Knee System (cemented lise) | ||
| Genesis II Knee System (uncemented use) |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Ms. Rishi Sinha Regulatory Affairs Specialist Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
DEC 2 0 2007
K073325 Re:
Trade/Device Name: Legion Porous Primary Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: November 26, 2007 Received: November 27, 2007
Dear Ms. 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.
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Page 2 - Ms. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Mark M. Millerson
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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Indications for Use
510(k) Number (if known): Device Name: Legion Porous Primary Femoral Component
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 level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. 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. Smith & Nephew Legion Porous Primary femoral components are indicated for use without bone cement and are single use devices.
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)
Darbarc Buchup
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Division of General, Restorative. and Neurological Devices
510(k) Number K073325
§ 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.