(27 days)
No
The summary describes a mechanical implant (knee component) and bench testing, with no mention of AI/ML terms or data processing that would suggest AI/ML is involved.
Yes
The device is a total knee replacement component, which is used to treat conditions like arthritis, aiming to restore function and alleviate pain, thus providing therapeutic benefit.
No
Explanation: The device described is a total knee component (femoral component) used for joint replacement, not for diagnosing diseases or conditions. The "Indications for Use" section specifies conditions for which the device is indicated, but the device itself is a treatment, not a diagnostic tool.
No
The device description clearly states the device is a "Femoral Component," which is a physical implantable device used in total knee replacement surgery. The summary discusses bench testing of this physical component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a total knee component used for treating various conditions affecting the knee joint (rheumatoid arthritis, osteoarthritis, etc.) and for revising failed knee replacements. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the physical characteristics of the femoral component, a part of a knee implant. It discusses its design, materials (porous, HA coating), and how it's used (without bone cement). This is consistent with a medical device intended for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device is directly implanted into the patient.
The information provided describes a Class II medical device (specifically, a knee prosthesis component) intended for surgical implantation.
N/A
Intended Use / Indications for Use
Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. LEGION Porous CR Narrow Femoral Components, with and without HA Coating, 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
The subject devices of this premarket notification are the LEGION Porous CR Narrow Femoral Components, which include catalog item offerings with and without HA Coating. These Femoral Components are indicated for use without bone cement applications. The subject devices are a line extension of the predicate devices listed, which are cleared under 510(k) submission numbers K073325 and K091543, with a modification in their femoral components' outer dimensions making them Narrow Femoral Components (similar to the cleared reference device: LEGION Narrow Oxinium CR and PS Femoral Components and Device Specific Instruments cleared under K112941). The overall design of the subject device is geometrically identical to the predicate devices LEGION Porous Femoral Components (K073325, K091543) with their outer dimensional changes making them Narrow Femoral Components (Reference device K112941).
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
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)
Bench testing was conducted or leveraged for the subject, implantable devices in comparison against one or more of the previously cleared predicate devices. The specific types of bench testing included:
- Tibiofemoral constraint analysis testing
- Tibiofemoral contact area analysis testing
- Patellofemoral resistance to lateral subluxation testing
The bench performance testing met the predefined acceptance criteria and the results demonstrated substantial equivalence to the cleared predicate.
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.
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.
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March 25, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Smith & Nephew, Inc. Michelle Huettner Director, Regulatory Affairs 1450 Brooks Road Memphis, Tennessee 38116
Re: K210566
Trade/Device Name: LEGION Porous CR Narrow 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: February 22, 2021 Received: February 26, 2021
Dear Michelle Huettner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210566
Device Name
LEGION Porous CR Narrow Femoral Components
Indications for Use (Describe)
Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartment, or total knee replacement. LEGION Porous CR Narrow Femoral Components are indicated for use without bone cement and are single use devices.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Submitted by: | Smith & Nephew, Inc.
Orthopaedics Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | March 18, 2021 |
| Contact Person and Address: | Michelle Huettner
Director, Regulatory Affairs
Phone: 765-426-6070
Michelle.Huettner@smith-nephew.com |
| Name of Device: | LEGION Porous CR Narrow Femoral
Components |
| Common Name: | Orthopedic Devices |
| 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 |
| Product Code: | MBH |
| Predicate Device: | Primary Predicate – K073325 - LEGION Porous
Primary Femoral Components |
| | Reference Device – K091543 - LEGION Porous
Plus HA Primary Femoral Components |
| | Reference Device (Narrow) – K112941 - LEGION
Narrow Oxinium CR and PS Femoral
Components and Device Specific Instruments |
Device Description
The subject devices of this premarket notification are the LEGION Porous CR Narrow Femoral Components, which include catalog item offerings with and without HA Coating. These Femoral Components are indicated for use without bone cement applications. The subject devices are a line extension of the predicate devices listed, which are cleared under 510(k) submission numbers K073325 and K091543, with a modification in their femoral components' outer
4
dimensions making them Narrow Femoral Components (similar to the cleared reference device: LEGION Narrow Oxinium CR and PS Femoral Components and Device Specific Instruments cleared under K112941). The overall design of the subject device is geometrically identical to the predicate devices LEGION Porous Femoral Components (K073325, K091543) with their outer dimensional changes making them Narrow Femoral Components (Reference device K112941).
Design Changes:
The Narrow versions of the Predicate Femoral Component sizes 3, 4, 5, 6, and 7 will have their Medial/Lateral Width and Anterior/Posterior Dimension reduced making them Narrow versions of the cleared predicate devices. The full list of the catalog item numbers in scope for the subject device is included in the Device Description of the submission.
Indication for Use:
Total Knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartmental replacement, or total knee replacement. LEGION Porous CR Narrow Femoral Components, with and without HA Coating, are indicated for use without bone cement and are single use devices.
Note, the Indications for Use for the subject devices (LEGION Porous CR Narrow Femoral Components) are the same as the cleared indications for the Predicate devices for the LEGION Porous CR Femoral Components, with and without HA Coating (K073325 and K091543 respectively).
Technological Characteristics
A review of the technological characteristics indicates that the LEGION Porous CR Narrow Femoral Components are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues raised related to the safety and effectiveness of the subject devices from Risk Management Plan.
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A review of this design verification testing of the modified Femoral components also demonstrate that the subject devices are equivalent to their cleared predicate devices in their intended use and no new issues/risks raised from these design changes.
Substantial Equivalence
The subject devices are substantially equivalent in function, intended use, indications for use, and material composition, and they are very similar in overall design to the cleared predicate devices.
| | Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------------|----------------------|---------------------------------------------------------------------------------------------|----------------------|-------------------|
| Primary
Predicate | Smith & Nephew, Inc. | LEGION Porous Primary Femoral Component | K073325 | 12/20/2007 |
| Reference
Device | Smith & Nephew, Inc. | LEGION Porous Plus HA Primary Femoral Component | K091543 | 12/21/2009 |
| Reference
Device | Smith & Nephew, Inc. | LEGION Narrow Oxinium CR and PS Femoral Components and Device Specific Instruments (Narrow) | K112941 | 12/20/2011 |
Table 5.1: Substantially Equivalent Predicates
Performance Testing:
To further support a determination of substantial equivalence, various types of bench testing were conducted or leveraged for the subject, implantable devices in comparison against one or more of the previously cleared predicate devices. The specific types of bench testing included:
- . Tibiofemoral constraint analysis testing
- . Tibiofemoral contact area analysis testing
- Patellofemoral resistance to lateral subluxation testing .
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There was no necessary animal pre-clinical testing or clinical testing in scope for the subject devices. In conclusion, the bench performance testing met the predefined acceptance criteria and the results demonstrated substantial equivalence to the cleared predicate.
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the LEGION Porous CR Narrow Femoral Components, which include catalog item offerings with and without HA Coating. Based on the similarities to the predicate devices, the subject devices are line extensions and substantially equivalent to the commercially available cleared predicate devices listed above.