(46 days)
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. Total knee components are single use devices and may be used in cemented or uncemented applications.
The Smith & Nephew, Inc. Gender Knee Systems are the existing Smith & Nephew, Inc. Genesis II, Legion, and Journey BCS Knee Systems. This premarket notification seeks only to add gender-related claims for these existing total knee systems previously cleared by FDA marketed by Smith & Nephew. No new total knee components being introduced as a result of this premarket notification.
This document is a 510(k) Pre-market Notification for the Smith & Nephew, Inc. Gender Knee Systems. It is a regulatory submission to the FDA seeking to add gender-related claims to existing total knee replacement systems.
Based on the provided text, the device is being cleared based on substantial equivalence to previously marketed predicate devices, not on a new study demonstrating its efficacy or performance against specific acceptance criteria. This type of submission (510(k)) does not typically involve the rigorous clinical trial evidence that would include specific acceptance criteria and a detailed study report as requested in your prompt.
Therefore, many of the requested elements are not present in this type of regulatory document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not describe specific performance-based acceptance criteria for the "Gender Knee Systems" or report performance results against such criteria. The submission is for "gender-related claims" for existing devices, relying on substantial equivalence to predicates.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No new clinical testing or "test set" is described for this 510(k) submission. The clearance is based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No "test set" requiring ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No "test set" and thus no adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. This document is about a knee implant, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This document is about a knee implant, not an algorithm, so this concept is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. As there's no new study or "test set" described, there's no mention of ground truth types.
8. The sample size for the training set
- Cannot be provided. This is not a machine learning/AI device, and no "training set" is relevant or mentioned.
9. How the ground truth for the training set was established
- Cannot be provided. As above, a training set and its ground truth establishment are not applicable to this device or its regulatory pathway.
Summary of what is known based on the provided text:
- Device Name: Smith & Nephew, Inc. Gender Knee Systems (based on existing Genesis II, Legion, and Journey BCS Knee Systems)
- Regulatory Pathway: 510(k) Premarket Notification
- Purpose of Submission: To add "gender-related claims" to existing, previously cleared total knee systems.
- Basis for Clearance: Substantial Equivalence to predicate devices, specifically:
- Intended Use: Standard total knee replacement indications for rheumatoid arthritis, post-traumatic arthritis, degenerative arthritis, and failed previous surgeries, tailored to posterior stabilized or constrained knee systems, in cemented or uncemented applications.
In essence, this document demonstrates that the FDA reviewed the application and determined that the "Gender Knee Systems" with the added gender-related claims are substantially equivalent to other legally marketed predicate devices, meaning no new performance acceptance criteria or detailed study results are included within this specific 510(k) summary.
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Summary of Safety and Effectiveness Smith & Nephew, Inc. Gender Knee Systems
Date of Summary: August 16, 2007
Contact Person and Address
Jason Sells Project Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, Tennessee 38116 T (901) 399-5520
AUG 1 7 2007
Name of Device: Smith & Nephew, Inc. Gender Knee Systems Common Name: Total Knee Prosthesis
Device Classification: 21 CFR 888.3560 (Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis – Class II); and 21 CFR 888.3565 (Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis - Class II)
Device Description
The Smith & Nephew, Inc. Gender Knee Systems are the existing Smith & Nephew, Inc. Genesis II, Legion, and Journey BCS Knee Systems. This premarket notification seeks only to add gender-related claims for these existing total knee systems previously cleared by FDA marketed by Smith & Nephew. No new total knee components being introduced as a result of this premarket notification.
Intended Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. Total knee components are single use devices and may be used in cemented or uncemented applications.
Substantial Equivalence Information
The Smith & Nephew, Inc. Gender Knee Systems are the existing Smith & Nephew, Inc. Genesis II, Legion, and Journey BCS Knee Systems previously cleared for market by FDA through various premarket notifications. The gender-specific claims being made about these devices are similar to those of the Zimmer NexGen Knee Gender Solutions Female (GSF) Femoral Components (K060370), the Zimmer Gender Solutions Natural-Knee Flex System (K070214), and the Stryker Triathlon Total Knee System (K053514).
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Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Mr. Jason Sells Project Manager, Regulatory Affairs 1450 Brooks Road Memphis, Tennessee 38116
AUG 17 2007
Re: K071790
Trade/Device Name: Gender Knee System 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: June 29, 2007 Received: July 2, 2007
Dear Mr. Sells:
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
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Page 2 - Mr. Jason Sells
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buell
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
K071790 510(k) Number (if known):
Device Name: Smith & Nephew, Inc. Gender Knee Systems
Indications for Use:
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/or lateral collateral ligament) are absent or incompetent. Total knee components are single use devices and may be used in cemented or uncemented applications.
Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Boucher
Division of General, Restorative. and Neurological Devices
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510(k) Number_K07179i
§ 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.