(23 days)
No
The document describes a mechanical knee implant component and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is a component of a total knee replacement system, which is used to treat conditions like rheumatoid arthritis and osteoarthritis, thereby restoring function and alleviating symptoms.
No.
The device is a knee implant component, and its intended uses and performance studies focus on mechanical function and biocompatibility rather than diagnosing medical conditions.
No
The device description explicitly states it is a physical component (tibia insert) made of polyethylene, indicating it is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a component for total knee replacement surgery, addressing conditions like arthritis and failed previous surgeries. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical components (tibia inserts), materials (polyethylene), and how they are used in a surgical context (part of a knee replacement system).
- Performance Studies: The performance studies mentioned are mechanical bench tests (range of motion, constraint, interlock strength) and bacterial endotoxin testing, which are relevant to the physical and biological safety of an implant, not the diagnostic performance of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device is a surgical implant, specifically a component for total knee replacement, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartment, 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 incompetent and the collateral ligaments remain intact.
The Smith & Nephew Legion Inserts with JRNY Lock are single use devices.
Product codes
JWH, MBH
Device Description
The subject of this Special 510(k) is the LEGION Inserts with JRNY Lock (LEGION Inserts). The subject LEGION Inserts are tibia insert components, and a line extension of the LEGION CR High Flex and Deep Dish inserts cleared under premarket notification K071071. The subject devices were modified by incorporating the identical JOURNEY II locking mechanism from the JOURNEY II CR and JOURNEY II BCS inserts, cleared under premarket notifications K121443 and K111711 respectively.
The subject LEGION Inserts have a size range of 1-2, 3-4, 5-6, 7-8mm with thicknesses of 9, 10, 11, 12, 13, 15, 18, 21mm, and come in cruciate-retaining high flexion (CR HF) and Deep Dish varieties. The LEGION Inserts are manufactured from 7.5MRad Cross-linked Polyethylene (XLPE) conforming to ASTM F648 and ISO 5834-2, as the predicate LEGION CR Inserts cleared under a premarket notification K071071.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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)
To further support a determination of substantial equivalence, leveraged non-clinical bench (mechanical) testing was utilized. A review of the leveraged mechanical data indicates that the subject LEGION Inserts are substantially equivalent to one or more of the previously cleared predicate devices listed in Table 5.1 above. The following performance testing were used as a basis for the determination of substantial equivalence.
- . Range of Motion and Constraint
- Tibiofemoral Contact Area Analysis ●
- Component Interlock Strength Testing
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
March 13, 2020
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Smith & Nephew, Inc. Konrad Wolfmeyer Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K200407
Trade/Device Name: LEGION Inserts with JRNY Lock Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: February 17, 2020 Received: February 19, 2020
Dear Konrad Wolfmeyer:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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 Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200407
Device Name LEGION Inserts with JRNY Lock
Indications for Use (Describe)
Total Knee components are indicated for rheumatoid arthritis, osteoarthritis, osteoarthritis, or degenerative arthritis; failed osteotomies, unicompartment, 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 incompetent and the collateral ligaments remain intact.
The Smith & Nephew Legion Inserts with JRNY Lock 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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3
Smith Nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | March 11, 2020 |
| Contact Person and Address: | Konrad Wolfmeyer
Regulatory Affairs Specialist
Phone: (901) 399-1367 |
| Name of Device: | LEGION Inserts with JRNY Lock |
| Common Name: | Tibial Articular Insert Components |
| Device Classification Name and
Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained
cemented prosthesis |
| | 21 CFR 888.3565 Knee joint patellofemorotibial
metal/polymer porous-coated uncemented
prosthesis. |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JWH, MBH |
| Predicate Device: | Primary Predicate - K071071 - Crosslinked
Polyethylene Articular Inserts
Predicate - K121443 – JOURNEY II CR Knee
System
Predicate - K111711 – JOURNEY II BCS Knee
System |
Device Description
The subject of this Special 510(k) is the LEGION Inserts with JRNY Lock (LEGION Inserts). The subject LEGION Inserts are tibia insert components, and a line extension of the LEGION CR High Flex and Deep Dish inserts cleared under premarket notification K071071. The subject devices were modified by incorporating the identical JOURNEY II locking mechanism from the JOURNEY II CR and JOURNEY II BCS inserts, cleared under premarket notifications K121443 and K111711 respectively.
The subject LEGION Inserts have a size range of 1-2, 3-4, 5-6, 7-8mm with thicknesses of 9, 10, 11, 12, 13, 15, 18, 21mm, and come in cruciate-retaining high flexion (CR HF) and Deep Dish varieties. The LEGION Inserts are manufactured from 7.5MRad Cross-linked Polyethylene
4
Smith Nephew
(XLPE) conforming to ASTM F648 and ISO 5834-2, as the predicate LEGION CR Inserts cleared under a premarket notification K071071.
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. Posterior stabilized knee systems are 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 Smith & Nephew LEGION Inserts with JRNY Lock are single use devices.
Technological Characteristics
A review of the technological characteristics indicates that the LEGION Inserts with JRNY Lock are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices
Substantial Equivalence Information
The subject devices are identical in function, intended use, indications for use, and material composition, and very similar in overall design to the predicate devices listed in the following table.
| Manufacturer | Description | Submission
Number | Clearance Date |
|-------------------------|--------------------------------------------------------|----------------------|----------------|
| Smith & Nephew,
Inc. | Crosslinked Polyethylene
Articular Inserts (LEGION) | K071071 | 9/19/2007 |
| Smith & Nephew,
Inc. | JOURNEY II CR Knee
System | K121443 | 8/13/2012 |
| Smith & Nephew,
Inc. | JOURNEY II BCS Knee
System | K111711 | 9/16/2011 |
Table 5.1: Substantially Equivalent Predicates
Performance Testing:
To further support a determination of substantial equivalence, leveraged non-clinical bench (mechanical) testing was utilized. A review of the leveraged mechanical data indicates that the subject LEGION Inserts are substantially equivalent to one or more of the previously cleared predicate devices listed in Table 5.1 above. The following performance testing were used as a basis for the determination of substantial equivalence.
- . Range of Motion and Constraint
5
Smith Nephew
- Tibiofemoral Contact Area Analysis ●
- Component Interlock Strength Testing
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Conclusion
As previously noted, this Special 510(k) Premarket Notification is being submitted to request clearance for the LEGION Inserts with JRNY Lock. Based on the similarities to the predicate devices, the devices are substantially equivalent to the commercially available predicate devices listed above.