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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Legion Cone System." This type of document is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It typically does not contain information about acceptance criteria for a study proving device performance in the way that a clinical trial or a formal performance study for an AI/CADe device would.

Instead, for this type of device (knee prosthesis components), the "acceptance criteria" are generally met through mechanical testing and a comparison to predicate devices, demonstrating substantial equivalence in design, materials, and intended use. The "study" proving it meets acceptance criteria is primarily a series of mechanical tests and a predicate comparison.

Therefore, I will interpret your request in the context of this document type, focusing on the mechanical testing performed and the comparison to predicate devices, rather than a clinical study evaluating AI performance.

Here's the breakdown of the information you requested based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" in a quantitative table with specific pass/fail values for each test. Instead, it states that a "mechanical evaluation" was conducted and that this evaluation "demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." This implies that the results of these tests were considered acceptable when compared to established standards for such devices or to the performance of predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Meet safety and effectiveness standards comparable to predicate devices for mechanical properties relevant to an orthopedic implant.	Mechanical evaluation demonstrated "no new issues related to the safety or effectiveness." The subject devices were found to be substantially equivalent to predicate devices based on these tests.

Specific Mechanical Tests Conducted:

Fatigue Strength
Push-Out Strength
Torsional Shear
Tensile Attachment Strength

The document states, "A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." This indicates the device passed these implied criteria by performing adequately in these mechanical tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The "tests" mentioned are mechanical tests on device components, not typically "data sets" in the context of AI/software or clinical trials. Therefore, concepts like country of origin or retrospective/prospective do not apply. The sample sizes for the mechanical tests (e.g., how many cones were tested for fatigue) are not disclosed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. The "ground truth" for a mechanical test is typically determined by the physics and engineering principles governing the test and measurement. There isn't an "expert" establishing ground truth in the way a clinical expert would for a diagnostic image. The "experts" involved would be the engineers and scientists conducting and analyzing the mechanical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods like 2+1 are used in clinical studies, especially for ground truth establishment in ambiguous cases. This is not relevant for mechanical testing of an orthopedic implant.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. An MRMC study or AI assistance is not relevant to the Legion Cone System, which is a physical implant component, not an AI/software device. The document explicitly states: "Clinical data was not needed to support the safety and effectiveness of the subject devices."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This refers to AI algorithm performance studies, which are not relevant to this physical orthopedic implant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the mechanical tests, the "ground truth" is established by the physical and engineering measurements against accepted standards and the performance of predicate devices. There is no biological "ground truth" like pathology or outcomes data from patients in this premarket notification for a mechanical device.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of mechanical testing for a physical implant. This concept applies to machine learning models.

9. How the ground truth for the training set was established

This information is not applicable/not provided. As there is no training set mentioned, the establishment of its ground truth is not relevant.

Summary

{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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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 Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	September 30, 2016
Contact Person and Address:	Ms. Dongeun KimRegulatory Affairs Specialist IT 901-399-1151F 901-566-7120
Name of Device:	Smith & Nephew, Inc. Legion Cone System
Common Name:	Knee Prosthesis
Device Classification Name andReference:	21 CFR 888.3560 Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cementedprosthesis21 CFR 888.3565 Knee joint patellofemorotibialmetal/polymer porous-coated uncemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	JWH, MBH

Device Description

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

{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:

1. Rheumatoid Arthritis.
1. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
1. Failed osteotomies, unicompartmental replacement, or total knee replacement.
1. 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.
1. 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.
1. 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 AspectReviewed	Legion Tibial andFemoral Cones(Subject Devices)	Zimmer TrabecularMetal™ Tibial andFemoral ConeAugments (PrimaryPredicate)	SMF Hip Stems withStiktite (StiktiteReference Predicate)	Genesis II HemiStepped Augment(Grit-BlastReferencePredicate)
510(k) Number	None, SubjectDevices	K053340	K080625, K103256,K123012	K951987
Manufacturer	Smith & Nephew,Inc.	Zimmer	Smith & Nephew, Inc.	Smith & Nephew, Inc.
SimilarIndications forUse	Yes	Yes	Yes	Yes
Size Offering	Femoral Cones:18mm, 20mm,22mm, 24mm,26mm, 28mm,30mm (innerdiameters) in oneheightTibial Cones: 18mm,20mm, 22mm,24mm, 26mm,28mm, 30mm (innerdiameters) inShort and Long	Femoral Cones: 30mm,40mm, 50mm; Small,Medium, and Large; M/Lor A/PTibial Cones: Full andStepped (15mm/30mm,30mm/15mm); Sizes 48-67	-1, 0, 1, 2, 3, 4, 5, 6, 7, 8,9	1-2, 3-4, 5-6, 7-8Thickness: 10mmand 15mm
SterilizationMethod	Gamma	Gamma	Gamma	Gamma
Material	Substrate - TitaniumAlloy (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-BlastSurface Exists	Yes	No	Yes	Yes
Cemented orCementless	Cemented andCementless	Cemented andCementless	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.

Regulation Number and Section

§ 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.