(209 days)
No
The summary describes a knee implant with a new coating and references predicate devices for mechanical equivalence, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for various medical conditions of the knee, such as arthritis and failed knee replacements, to provide a therapeutic benefit by restoring function and alleviating symptoms.
No
The device description clearly states it is a femoral component for knee replacement surgery, and the intended use describes indications for arthritis, osteotomies, and knee replacements, which are all treatment-oriented, not diagnostic.
No
The device description clearly states it is a femoral component, which is a physical implant used in knee replacement surgery. It is a hardware device, not software.
Based on the provided text, 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 detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a total knee component, which is an implant used in surgery to replace a damaged knee joint. The intended use describes the conditions for which the implant is indicated (arthritis, failed surgeries, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on in vitro analysis.
This device is a surgical implant, not an in vitro diagnostic device.
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 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 primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are indicated for use without bone cement and are single use devices.
Product codes
MBH
Device Description
Legion Porous Plus HA Primary Femoral Components are geometrically identical to the Legion Porous Primary femoral components cleared via K073325. This premarket notification seeks only to add a hydroxylapatite (HA) coating to the porous coated areas of the femoral implants. The subject devices will be initially offered in both cruciate retaining (CR) and posterior stabilizing (PS) designs in sizes 1-8 in right and left hand configurations. The subject devices will utilize the same articular inserts as the non-HA coated Legion Porous Primary femoral components cleared via K073325 and will use existing Genesis II tibial baseplate and patellar components cleared via K030612.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
Mechanical Testing
A review of the mechanical testing results indicated that the Legion Porous Plus HA Primary Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary of Safety and Effectiveness LEGION® Porous Plus HA Primary Femoral Components
Date of Summary: May 22, 2009
Contact Person and Address Jason Sells Manager, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 (901) 399-5520
DEC 2 1 2009
Name of Device: Smith & Nephew Legion Porous Plus HA Primary Femoral Components Common Name: Femoral Knee Prosthesis
Device Classification Name and Reference: 21 CFR 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (Class II)
Device Product Code: MBH
Device Description
Legion Porous Plus HA Primary Femoral Components are geometrically identical to the Legion Porous Primary femoral components cleared via K073325. This premarket notification seeks only to add a hydroxylapatite (HA) coating to the porous coated areas of the femoral implants. The subject devices will be initially offered in both cruciate retaining (CR) and posterior stabilizing (PS) designs in sizes 1-8 in right and left hand configurations. The subject devices will utilize the same articular inserts as the non-HA coated Legion Porous Primary femoral components cleared via K073325 and will use existing Genesis II tibial baseplate and patellar components cleared via K030612.
Mechanical Testing
A review of the mechanical testing results indicated that the Legion Porous Plus HA Primary Femoral Components are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure.
Intended Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, or degenerative anthritis 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 primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are indicated for use without bone cement and are single use devices.
Substantial Equivalence Information
The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are similar in overall design, indications, and materials to the Legion Porous Primary femoral components cleared via K073325. The subject devices feature the same HA coating as devices in the Genesis II Porous Plus HA Knee System cleared via K032683.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Mr. Jason Sells Orthopaedic Division 1450 E Brooks Road Memphis, Tennessee 38116
DEC 2 1 2009
Re: K091543
Trade/Device Name: Legion Porous Plus HA Primary Femoral Components 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: December 8, 2009 Received: December 9, 2009
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 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
2
Page 2 - Mr. Jason Sells
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/dgfault.htm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic, and Restorative 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 Plus HA Primary Femoral Components
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 primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. The Smith & Nephew Legion Porous Plus HA Primary Femoral Components are indicated for use without bone cement and are single use devices.
Prescription Use × (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)
FOR M. MELKERSON
(Division Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K091543