Legion Cone System

K162775 · Smith & Nephew, Inc. · JWH · Jan 13, 2017 · Orthopedic

Device Facts

• Record ID: K162775
• Device Name: Legion Cone System
• Applicant: Smith & Nephew, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Jan 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

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. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. 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. 5. 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. 6. 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 Story

Legion Cone System consists of porous-coated titanium alloy (Ti-6Al-4V) tibial and femoral augments; designed to address cavitary bone defects in proximal tibia or distal femur during knee revision or primary surgery. Implants are conically shaped with central cannulation for fixation to Legion Revision and Legion Hinge knee system components (baseplates, stems, couplers). Used in clinical/OR settings by orthopedic surgeons. Implants provide structural support for prosthetic components in patients with significant bone loss; can be used with or without bone cement. Surgeon prepares bone site using provided instrumentation; implants are single-use.

Clinical Evidence

Bench testing only. Mechanical evaluation included fatigue strength, push-out strength, torsional shear, and tensile attachment strength. No clinical data was required to support safety and effectiveness.

Technological Characteristics

Substrate: Titanium alloy (Ti-6Al-4V) per ASTM F1472. Porous coating: C.P. Titanium per ASTM F67 (Stiktite). Interior surface: Grit-blasted for cement adhesion. Form factor: Conical, cannulated augments. Sterilization: Gamma radiation. Connectivity: None (mechanical implant).

Indications for Use

Indicated for patients requiring primary or revision knee surgery with rheumatoid, post-traumatic, osteoarthritis, or degenerative arthritis, or failed previous knee procedures (osteotomy, unicompartmental, or total knee replacement). Specific use depends on ligamentous stability: posterior stabilized (cruciates incompetent, collaterals intact), constrained (cruciate and one/both collaterals incompetent), or hinge (cruciate and one/both collaterals absent/incompetent).

Regulatory Classification

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).

Predicate Devices

• Zimmer Trabecular Metal Tibial and Femoral Cone Augments (K053340)

Reference Devices

• Smith & Nephew SMF Hip Stems (K080625, K103256, K123012)
• Smith & Nephew Genesis II Total Knee System (K951987)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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:

1. Rheumatoid arthritis.

2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.

3. Failed osteotomies, unicompartmental replacement, or total knee replacement.

4. 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.

5. 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.

6. 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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| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 East Brooks Road<br>Memphis, Tennessee 38116 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | September 30, 2016 |
| Contact Person and Address: | Ms. Dongeun Kim<br>Regulatory Affairs Specialist I<br>T 901-399-1151<br>F 901-566-7120 |
| Name of Device: | Smith & Nephew, Inc. Legion Cone System |
| Common Name: | Knee Prosthesis |
| Device Classification Name and<br>Reference: | 21 CFR 888.3560 Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented<br>prosthesis<br>21 CFR 888.3565 Knee joint patellofemorotibial<br>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

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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.
- 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis.
- 3. Failed osteotomies, unicompartmental replacement, or total knee replacement.
- 4. 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.
- 5. 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.
- 6. 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.

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| Design Aspect<br>Reviewed | Legion Tibial and<br>Femoral Cones<br>(Subject Devices) | Zimmer Trabecular<br>Metal™ Tibial and<br>Femoral Cone<br>Augments (Primary<br>Predicate) | SMF Hip Stems with<br>Stiktite (Stiktite<br>Reference Predicate) | Genesis II Hemi<br>Stepped Augment<br>(Grit-Blast<br>Reference<br>Predicate) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 510(k) Number | None, Subject<br>Devices | K053340 | K080625, K103256,<br>K123012 | K951987 |
| Manufacturer | Smith & Nephew,<br>Inc. | Zimmer | Smith & Nephew, Inc. | Smith & Nephew, Inc. |
| Similar<br>Indications for<br>Use | Yes | Yes | Yes | Yes |
| Size Offering | Femoral Cones:<br>18mm, 20mm,<br>22mm, 24mm,<br>26mm, 28mm,<br>30mm (inner<br>diameters) in one<br>height<br>Tibial Cones: 18mm,<br>20mm, 22mm,<br>24mm, 26mm,<br>28mm, 30mm (inner<br>diameters) in<br>Short and Long | Femoral Cones: 30mm,<br>40mm, 50mm; Small,<br>Medium, and Large; M/L<br>or A/P<br>Tibial Cones: Full and<br>Stepped (15mm/30mm,<br>30mm/15mm); Sizes 48-<br>67 | -1, 0, 1, 2, 3, 4, 5, 6, 7, 8,<br>9 | 1-2, 3-4, 5-6, 7-8<br>Thickness: 10mm<br>and 15mm |
| Sterilization<br>Method | Gamma | Gamma | Gamma | Gamma |
| Material | Substrate - Titanium<br>Alloy (ASTM F1472)<br>Porous Coating -<br>C.P. Titanium<br>(ASTM F67) | Trabecular™ Metal | Substrate - Titanium Alloy<br>(ASTM F1472)<br>Porous Coating - C.P.<br>Titanium (ASTM F67) | Ti 6Al 4V<br>(ASTM F1472) |
| Grit-Blast<br>Surface Exists | Yes | No | Yes | Yes |
| Cemented or<br>Cementless | Cemented and<br>Cementless | Cemented and<br>Cementless | Cementless | Cemented |

# Table 5.1: Predicate Comparison Matrix – Legion Tibial and Femoral Cones

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### 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.