(77 days)
Not Found
No
The 510(k) summary describes a mechanical implant (femoral components for total knee replacement) and associated instruments. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies described are mechanical tests of the implant's physical properties and interactions.
Yes
The device is a total knee replacement component used to treat various types of arthritis and failed knee replacements, which are medical conditions, thus performing a therapeutic function.
No
The device description clearly states it is comprised of "Legion Narrow Oxinium Cruciate Retaining (CR) and Posterior Stabilized (PS) Femoral Components," which are implantable devices for total knee replacement rather than tools for diagnosis.
No
The device description explicitly states that the devices are "implant devices" comprised of "femoral components" made from "oxidized zirconium alloy material." It also mentions "device specific instruments." These are all physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a total knee component used for surgical implantation to treat various forms of arthritis and failed previous knee surgeries. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as an implantable femoral component made of oxidized zirconium alloy. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Anatomical Site: The anatomical site is the knee joint, which is where the implant is placed, not where a specimen is collected for analysis.
- Performance Studies: The performance studies described are pre-clinical tests on the physical implant's mechanical properties and interactions with other components, not studies evaluating the accuracy of a diagnostic test.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a surgical implant used in the human body for treatment.
N/A
Intended Use / Indications for Use
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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.
Smith & Nephew, Inc. Legion Narrow Oxinium CR and PS Femoral Components are indicated for single use only and for use only with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The implant devices described in this premarket notification are comprised of Legion Narrow Oxinium Cruciate Retaining (CR) and Posterior Stabilized (PS) Femoral Components. All described implant components are manufactured from oxidized zirconium alloy material (trade name: Oxinium). The subject devices are available in the following configurations and sizes:
| Device Type | Hand | Available Sizes |
|---|---|---|
| Legion Narrow Oxinium CR Femoral Components | Left | 3, 4, 5 and 6 |
| Legion Narrow Oxinium CR Femoral Components | Right | 3, 4, 5 and 6 |
| Legion Narrow Oxinium PS Femoral Components | Left | 3, 4, 5 and 6 |
| Legion Narrow Oxinium PS Femoral Components | Right | 3, 4, 5 and 6 |
Device specific instruments are also described in this premarket notification in select sections and exhibits.
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)
Preclinical Testing:
To further support a determination of substantial equivalence, various types of pre-clinical testing were conducted on the subject, implantable devices in comparison against one or more of the previously cleared predicate devices described above. The specific types of pre-clinical testing included:
- Tibiofemoral Constraint Testing of femorals against interfacing polyethylene articular insert components seated in appropriate metal tibial bases in A/P Draw, M/L Shear and rotary laxity (R/L)
- Tibiofemoral Contact Area Testing of femorals against interfacing polyethylene articular insert components seated in appropriate metal tibial bases
- Patellofemoral Subluxation Testing of the femoral to determine the amount of resistance to lateral subluxation of the patellofemoral interface
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.
Not Found
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
§ 888.3560 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
510(k) Summary of Safety and Effectiveness Legion Narrow Oxinium CR and PS Femoral Components and Device Specific Instruments
| Submitted By: | Smith & Nephew, Inc.
Orthopaedics
1450 Brooks Road
Memphis, TN 38116 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Date: | October 3, 2011 |
| Contact Person: | David Henley, Regulatory Affairs Project Manager
Tel: (901) 399-6487 Fax: (901) 566-7079 |
| Proprietary Name: | Legion Narrow Oxinium CR and PS Femoral
Components and Instruments |
| Common Name: | Total Knee Prosthesis |
| Classification Name and Reference: | 21 CFR 888.3560, Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented
prosthesis |
| Device Class | Class II |
| Device Product Code and Panel Code: | JWH / Orthopedics / 87 |
Device Description:
The implant devices described in this premarket notification are comprised of Legion Narrow Oxinium Cruciate Retaining (CR) and Posterior Stabilized (PS) Femoral Components. All described implant components are manufactured from oxidized zirconium alloy material (trade name: Oxinium). The subject devices are available in the following configurations and sizes:
| Device Type | Hand | Available Sizes |
|---|---|---|
| Legion Narrow Oxinium CR Femoral Components | Left | 3, 4, 5 and 6 |
| Legion Narrow Oxinium CR Femoral Components | Right | 3, 4, 5 and 6 |
| Legion Narrow Oxinium PS Femoral Components | Left | 3, 4, 5 and 6 |
| Legion Narrow Oxinium PS Femoral Components | Right | 3, 4, 5 and 6 |
Device specific instruments are also described in this premarket notification in select sections and exhibits.
Intended Use:
Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, 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.
Smith & Nephew, Inc. Legion Narrow Oxinium CR and PS Femoral Components are indicated for single use only and for use only with bone cement.
1
Technological Characteristics:
Components comprising Legion Narrow Oxinium CR and PS Femoral Components are verv similar to the legally marketed devices listed below. When compared to the predicates, the proposed devices share very similar or identical Indications for Use, intended use, are manufactured from similar or identical materials, and incorporate very similar technological design characteristics.
Substantial Equivalence Information:
When compared to the implant and device specific instrument predicate devices listed below. substantial equivalence is based on similarities with regard to overall indications for use, material composition, and technological design characteristics.
- · Genesis II Total Knee System K951987
- · Genesis II and Profix Zirconium Femoral Components K962557
- · Legion Primary Knee System K093746
Preclinical Testing:
To further support a determination of substantial equivalence, various types of pre-clinical testing were conducted on the subject, implantable devices in comparison against one or more of the previously cleared predicate devices described above. The specific types of pre-clinical testing included:
- · Tibiofemoral Constraint Testing of femorals against interfacing polyethylene articular insert components seated in appropriate metal tibial bases in A/P Draw, M/L Shear and rotary laxity (R/L)
- · Tibiofemoral Contact Area Testing of femorals against interfacing polyethylene articular insert components seated in appropriate metal tibial bases
- Patellofemoral Subluxation Testing of the femoral to determine the amount of resistance to lateral subluxation of the patellofemoral interface
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 0 2011
Smith & Nephew, Inc. Orthopaedics Division % Mr. David Henley Regulatory Affairs Project Manager 7135 Goodlet Farms Parkway Cordova, Tennessee 38016
Re: K112941
Trade/Device Name: Legion Narrow Oxinium Cruciate Retaining (CR) and Posterior Stabilized (PS) Femoral Components and Device Specific Instruments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: October 3, 2011 Received: October 4, 2011
Dear Mr. Henley:
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. 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.
3
Page 2 - Mr. David Henley
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); 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Erine Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification
Indications for Use Statement
510(k) Number (if known): _ K || 29 H |
Device Name: Legion Narrow Oxinium C/R and P/S Femoral Components
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. 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.
Smith & Nephew, Inc. Legion Narrow Oxinium C/R and P/S Femoral Components are indicated for use only with cement and are single use only devices.
x Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Part 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)
for Mark Melkerson
(Division Sign-Off) (Division Sign-On), Orthopedic, Division of Restorative Devices
510(k) Number .