JOURNEY II Unicompartmental Knee System

K191211 · Smith & Nephew, Inc. · HSX · Jul 25, 2019 · Orthopedic

Device Facts

• Record ID: K191211
• Device Name: JOURNEY II Unicompartmental Knee System
• Applicant: Smith & Nephew, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Jul 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following: - · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. - · Correction of functional deformity. - · Revision of previous arthroplasty procedures. - · Treatment of fractures that are unmanageable using other techniques. Unicompartmental knee implants are single use only and are intended for implantation only with bone cement

Device Story

The JOURNEY II Unicompartmental Knee System is a prosthetic implant for knee joint replacement. It consists of a femoral implant, a tibial baseplate, and a modular articular insert. The device is intended for surgical implantation by an orthopedic surgeon to restore knee function in patients with degenerative joint disease or other specified conditions. The system is designed for use with bone cement. This specific submission updates the device labeling to include MR conditional safety information and clarifies the definition of revision cases in the indications for use. The device is a passive implant; it does not involve electronic processing, software, or algorithms.

Clinical Evidence

Bench testing only. The submission provides MRI compatibility testing results, including magnetically induced displacement force (ASTM F2052), torque (ASTM F2213), RF-induced heating (ASTM F2182), and MR image artifact assessment (ASTM F2119), to support the MR conditional labeling update.

Technological Characteristics

Passive orthopedic implant system consisting of femoral implant, tibial baseplate, and modular articular insert. Designed for cemented fixation. MR conditional status established via testing per ASTM F2052, F2213, F2182, and F2119.

Indications for Use

Indicated for patients requiring restoration of a knee compartment due to non-inflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), functional deformity, revision of previous arthroplasty, or unmanageable fractures. For single use only; must be implanted with bone cement.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• JOURNEY II Unicompartmental Knee System (K190085)
• Zimmer Unicompartmental Knee System (K160738)

Submission Summary (Full Text)

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July 25, 2019

Smith & Nephew, Inc. Meenakshi Gupta Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

## Re: K191211

Trade/Device Name: JOURNEY II Unicompartmental Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX, KRR, NPJ Dated: May 3, 2019 Received: May 6, 2019

## Dear Meenakshi Gupta:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

FOR Vesa Vuniqi, MS 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

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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K191211

Device Name

JOURNEY II Unicompartmental Knee System

### Indications for Use (Describe)

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

- · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- · Correction of functional deformity.
- · Revision of previous arthroplasty procedures.
- · Treatment of fractures that are unmanageable using other techniques.

Unicompartmental knee implants are single use only and are intended for implantation only with 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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# 510(K) SUMMARY

| Submitted by: | Smith & Nephew, Inc.<br>Advanced Surgical Devices Division<br>7135 Goodlett Farms Parkway<br>Cordova, Tennessee 38016 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | May 3, 2019 |
| Contact Person: | Meenakshi Gupta, Sr. Regulatory Affairs Specialist<br>T [phone]<br>F [phone] |
| Name of Device: | Smith & Nephew, Inc. JOURNEY II® Unicompartmental<br>Knee System (Journey II UK) |
| Common Name: | Knee Prosthesis |
| Device Classification<br>Name and Reference: | 21 CFR 888.3520 Knee Joint Femorotibial<br>Metal/Polymer Non-Constrained Cemented Prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HSX, KRR, NPJ |
| Predicate Device: | Primary Predicate: JOURNEY II® Unicompartmental<br>Knee System (Journey II UK)–K190085<br>Secondary Predicate: Zimmer Unicompartmental Knee<br>System–K160738<br>The predicate devices have not been subject to a<br>design related recall. |

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## Device Description:

The subject of this traditional 510(k) is to add the MR safety information to the Journey II Unicompartmental Knee System (Journey II UK) labeling. The Journey II UK was cleared under K190085.

Journey II UK system consist of a femoral implant, tibia baseplate, modular articular insert, and requisite US Class II surgical instruments.

The package insert and label of Journey II UK is being updated to add MR conditional information.

The indication for use of Journey II UK system was updated to clarify the definition of the revision cases. This change does not change the indication for use.

## Indications for Use

Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

- . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
- . Correction of functional deformity.
- . Revision of previous arthroplasty procedures.
- . Treatment of fractures that are unmanaqeable using other techniques.

Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

# Technological Characteristics

The device design, material, and indications for use of the subject device are same as the predicate JOURNEY II UK system cleared under K190085.

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## Performance Data

Below listed Magnetic resonance imaging (MRI) compatibility testing were conducted as per the FDA's guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", December 11, 2014 and the standards listed below:

- 1. Magnetically induced displacement force (ASTM F2052)
- 2. Magnetically induced torque (ASTM F2213)
- 3. Radiofrequency (RF) induced heating (ASTM F2182)
- 4. MR image artifact (ASTM F2119)

## Substantial Equivalence Information

The device design, materials, and indications for use for the Journey II UK are substantially equivalent to the commercially available predicate devices identified in table below:

## Table 6.1: Predicates to the Journey II UK

| Manufacturer | Description | Submission<br>Number | Clearance<br>Date |
|----------------------|----------------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | Journey II Unicompartmental<br>Knee System | K190085 | 02/11/2019 |
| Smith & Nephew, Inc. | Zimmer Unicompartmental<br>Knee System (ZUK) | K160738 | 06/15/2016 |

## Conclusion

In summary, the Smith & Nephew's JOURNEY II Unicompartmental Knee System is identical in function, design features, intended use, indications for use, materials, sterilization, manufacturing methods, and operational principles as the predicate device JOURNEY II Unicompartmental Knee System cleared under K190085