(102 days)
No
The device description and performance studies focus on the mechanical properties and materials of the implants, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an implant for knee replacement surgery, intended to treat conditions like arthritis and failed joint replacements, which are therapeutic uses.
No
The device description indicates that the Legion Cones are "porous coated tibial and femoral augments to address cavitary defects" and are "single use implants and are intended for use with and without bone cement." They are components of knee replacement systems, which are therapeutic implants, not diagnostic tools.
No
The device description clearly states the device consists of physical components made of titanium alloy (tibial and femoral cones) and includes necessary instrumentation for surgical implantation. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Legion Cones are described as porous coated tibial and femoral augments, which are implants intended to be surgically placed within the body to address bone defects.
- Intended Use: The intended use clearly states that the Legion Cones are for use with knee systems in surgical procedures to treat various conditions affecting the knee joint.
The device is a surgical implant, not a diagnostic tool used with in vitro specimens.
N/A
Intended Use / Indications for Use
The Legion Cones are intended to be used with the Legion Revision and Legion Hinge knee systems. The Legion Cones are indicated for the following:
-
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.
-
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 collateral ligament) are incompetent.
-
Hinge 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 collateral ligament) are absent of incompetent.
These are single use implants and are intended for use with and without bone cement.
Product codes (comma separated list FDA assigned to the subject device)
JWH, MBH
Device Description
Subject of this Traditional premarket notification is the Smith & Nephew Legion™ Cone System. The Smith & Nephew Legion Cone System consists of porous coated tibial and femoral augments to address cavitary defects in the proximal tibia or distal femur. The system will also include the necessary instrumentation for the surgeon to prepare the tibia and femur for implantation of the augments.
The components of the Smith & Nephew Legion Cone System are as follows:
- Titanium alloy (Ti-6Al-4V) tibial cones of 2 heights and 7 sizes .
- Titanium alloy (Ti-6Al-4V) hand-specific femoral cones of 1 height and 7 sizes
The Leqion Tibial and Femoral Cones are a one piece, conically shaped device with cannulation all the way through the cone which allows fixation to the Legion Revision and Legion Hinge tibial baseplates, femoral components, offset couplers, augments/wedges, and stem constructs.
The Legion Tibial and Femoral Cones are similar to the primary predicate Zimmer Trabecular™ Metal Tibial and Femoral Cone Augments cleared via premarket notification K053340. The Legion Tibial Cones will be available in heights of 25mm (short) and 40mm (long) and inner diameters (ID) of 18mm-30mm, in 2mm increments. The Legion Femoral Cones will be available in a height of approximately 35mm and inner diameters of 18mm-30mm, in 2mm increments. The Legion Femoral Cones will be provided in left and right orientations. The subject tibial and femoral cones are manufactured from forged titanium alloy (Ti-6Al-4V) that conforms to ASTM F 1472. The subject tibial and femoral cones also have an external asymmetric (Stiktite™) porous coating specification identical to the porous coating of the reference predicate Smith & Nephew SMF™ Hip Stems cleared via premarket notifications K080625. K103256, and K123012. The interior side of the subject cones has a grit-blasted surface specification for cement adhesion identical to the gritblasted surface of reference predicate Smith & Nephew Genesis II Total Knee System cement-on-augment devices cleared via premarket notification K951987.
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)
Smith & Nephew has conducted a mechanical evaluation of the subject Legion Tibial and Femoral Cone Augments of the following:
- Fatigue Strength
- Push-Out Strength .
- Torsional Shear ●
- Tensile Attachment Strength o
A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
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.
K080625, K103256, K123012, K951987
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a flowing ribbon representing the snake.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2017
Smith & Nephew, Inc. Ms. Dongeun Kim Regulatory Affairs Specialist I 1450 Brooks Road Memphis. Tennessee 38116
Re: K162775 Trade/Device Name: Legion Cone System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: September 7, 2016 Received: October 3, 2016
Dear Ms. Dongeun Kim:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) WX K162775
Device Name Smith & Nephew Legion Cone System
Indications for Use (Describe)
The Legion Cones are intended to be used with the Legion Revision and Legion Hinge knee systems. The Legion Cones are indicated for the following:
-
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.
-
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 collateral ligament) are incompetent.
-
Hinge 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 collateral ligament) are absent of incompetent.
These are single use implants and are intended for use with and without bone cement.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image displays the Smith & Nephew logo. The logo features an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "smith&nephew" are in orange, while "We are" is in gray.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | September 30, 2016 |
| Contact Person and Address: | Ms. Dongeun Kim
Regulatory Affairs Specialist I
T 901-399-1151
F 901-566-7120 |
| Name of Device: | Smith & Nephew, Inc. Legion Cone System |
| Common Name: | Knee Prosthesis |
| 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 |
Device Description
Subject of this Traditional premarket notification is the Smith & Nephew Legion™ Cone System. The Smith & Nephew Legion Cone System consists of porous coated tibial and femoral augments to address cavitary defects in the proximal tibia or distal femur. The system will also include the necessary instrumentation for the surgeon to prepare the tibia and femur for implantation of the augments.
The components of the Smith & Nephew Legion Cone System are as follows:
- Titanium alloy (Ti-6Al-4V) tibial cones of 2 heights and 7 sizes .
- · Titanium alloy (Ti-6Al-4V) hand-specific femoral cones of 1 height and 7 sizes
The Leqion Tibial and Femoral Cones are a one piece, conically shaped device with cannulation all the way through the cone which allows fixation to the Legion Revision and Legion Hinge tibial baseplates, femoral components, offset couplers, augments/wedges, and stem constructs.
The Legion Tibial and Femoral Cones are similar to the primary predicate Zimmer Trabecular™ Metal Tibial and Femoral Cone Augments cleared via premarket notification K053340. The Legion Tibial Cones will be available in heights of 25mm (short) and 40mm (long) and inner diameters (ID) of 18mm-30mm, in 2mm increments. The Legion Femoral Cones will be available in a height of approximately 35mm and inner diameters of 18mm-30mm, in 2mm increments. The Legion Femoral Cones will be provided in left and right orientations. The subject tibial and femoral cones are manufactured from forged titanium alloy (Ti-6Al-4V) that conforms to ASTM F 1472. The subject tibial and femoral cones also have an external
4
asymmetric (Stiktite™) porous coating specification identical to the porous coating of the reference predicate Smith & Nephew SMF™ Hip Stems cleared via premarket notifications K080625. K103256, and K123012. The interior side of the subject cones has a grit-blasted surface specification for cement adhesion identical to the gritblasted surface of reference predicate Smith & Nephew Genesis II Total Knee System cement-on-augment devices cleared via premarket notification K951987.
Intended Use
The Legion Cones are intended to be used with the Legion Revision and Legion Hinge knee systems. The Legion Cones are indicated for the following:
-
- 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.
-
- 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 ligament) are incompetent.
-
- Hinge 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 ligament) are absent or incompetent.
These are single use implants and are intended for use with and without bone cement.
Technological Characteristics
Smith & Nephew has conducted a mechanical evaluation of the subject Legion Tibial and Femoral Cone Augments of the following:
- Fatigue Strength
- Push-Out Strength .
- Torsional Shear ●
- Tensile Attachment Strength o
A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Substantial Equivalence Information
The intended use, indications for use and technological characteristics of the subject Smith & Nephew Legion Tibial and Femoral Cones are substantially equivalent to the predicate devices listed in Table 5.1 below.
5
| Design Aspect
Reviewed | Legion Tibial and
Femoral Cones
(Subject Devices) | Zimmer Trabecular
Metal™ Tibial and
Femoral Cone
Augments (Primary
Predicate) | SMF Hip Stems with
Stiktite (Stiktite
Reference Predicate) | Genesis II Hemi
Stepped Augment
(Grit-Blast
Reference
Predicate) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) Number | None, Subject
Devices | K053340 | K080625, K103256,
K123012 | K951987 |
| Manufacturer | Smith & Nephew,
Inc. | Zimmer | Smith & Nephew, Inc. | Smith & Nephew, Inc. |
| Similar
Indications for
Use | Yes | Yes | Yes | Yes |
| Size Offering | Femoral Cones:
18mm, 20mm,
22mm, 24mm,
26mm, 28mm,
30mm (inner
diameters) in one
height
Tibial Cones: 18mm,
20mm, 22mm,
24mm, 26mm,
28mm, 30mm (inner
diameters) in
Short and Long | Femoral Cones: 30mm,
40mm, 50mm; Small,
Medium, and Large; M/L
or A/P
Tibial Cones: Full and
Stepped (15mm/30mm,
30mm/15mm); Sizes 48-
67 | -1, 0, 1, 2, 3, 4, 5, 6, 7, 8,
9 | 1-2, 3-4, 5-6, 7-8
Thickness: 10mm
and 15mm |
| Sterilization
Method | Gamma | Gamma | Gamma | Gamma |
| Material | Substrate - Titanium
Alloy (ASTM F1472)
Porous Coating -
C.P. Titanium
(ASTM F67) | Trabecular™ Metal | Substrate - Titanium Alloy
(ASTM F1472)
Porous Coating - C.P.
Titanium (ASTM F67) | Ti 6Al 4V
(ASTM F1472) |
| Grit-Blast
Surface Exists | Yes | No | Yes | Yes |
| Cemented or
Cementless | Cemented and
Cementless | Cemented and
Cementless | Cementless | Cemented |
Table 5.1: Predicate Comparison Matrix – Legion Tibial and Femoral Cones
6
Conclusion
This Traditional 510(k) Premarket Notification is being submitted to request clearance for the Smith & Nephew Legion Cone System. Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject devices are substantially equivalent to the above predicate devices.