The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.
The patient's need for knee replacement should be due to one or more of the following conditions:

Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis.
Inflammatory degenerative joint disease including rheumatoid arthritis.
Functional deformity such as varus, valgus or flexion deformities.
Revision procedures where other treatments or devices have failed.
Fractures that are unmanageable using other techniques.
The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Device Description

The World Knee system is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate. The femoral component and tibial baseplate components are manufactured from cast cobalt chromium alloy and are intended for use with bone cement. The modular femoral peg is manufactured from wrought cobalt chromium alloy. The femoral component and meniscal inserts are available as posterior stabilised or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the meniscal insert and patella are manufactured from UHMWPE.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the World Knee System, formatted to address your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance
Performance relative to predicate device	Performance is "equal or better than the predicate device"
Adequacy for anticipated in-vivo use	Confirmed "adequate for anticipated in-vivo use"
Substantial equivalence to predicate device	Claimed substantial equivalence based on intended use, indications for use, materials, and similar design. Similarities also stated for manufacturing process, geometry, fundamental design, body contact, and sterilization process.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not contain information on a test set sample size or data provenance (e.g., country of origin, retrospective/prospective) related to clinical or human-use testing. The "Performance Testing" section states "Engineering evaluations were conducted," suggesting in vitro or simulation-based testing, not human subject data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable based on the provided text. The performance testing was described as "Engineering evaluations," implying a lack of ground truth established by medical experts for a clinical test set.

4. Adjudication Method for the Test Set

This information is not applicable as the text does not describe a clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The document focuses on engineering evaluations to demonstrate equivalence to a predicate device, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The device is a knee prosthesis, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance testing refers to the physical device's characteristics and its comparison to a predicate device.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation appears to be based on engineering standards and direct comparison of physical and material properties to the predicate device, rather than clinical outcomes, pathology, or expert consensus from human subjects. The phrase "Engineering evaluations were conducted to verify that the performance...is equal or better than the predicate device" implies a comparative engineering assessment.

8. The Sample Size for the Training Set

This information is not applicable. The "World Knee System" is a physical medical device (a knee prosthesis), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is not an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 Australia

April 20, 2018

Re: K180750

Trade/Device Name: World Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 15, 2018 Received: March 22, 2018

Dear Declan Brazil:

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 of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in 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.

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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180750

Device Name World Knee System

Indications for Use (Describe)

The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.

The patient's need for knee replacement should be due to one or more of the following conditions:
· Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis.
· Inflammatory degenerative joint disease including rheumatoid arthritis.
· Functional deformity such as varus, valgus or flexion deformities.
· Revision procedures where other treatments or devices have failed.
· Fractures that are unmanageable using other techniques.

The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

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

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device Trade Name:	World Knee System
Common Name:	Total Knee Prosthesis
Contact:	Dr. Declan Brazil
	Managing Director of Signature Orthopaedics
Prepared By:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066AustraliaPhone: +61 (2) 9428 5181Fax: +61 (2) 8456 6065
Date Prepared:	January 12th, 2018
Classification:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (JWH, 21CFR 888.3560)
Predicate Devices:	Substantial equivalence to the following device is claimed:
	● Signature Orthopaedics Genius Total Knee System(K170613)

Device Description:

Indications for Use:

The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.

The patient's need for knee replacement should be due to one or more of the following

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conditions:

Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
. Inflammatory degenerative joint disease including rheumatoid arthritis.
. Functional deformity such as varus, valgus or flexion deformities.
. Revision procedures where other treatments or devices have failed.
Fractures that are unmanageable using other techniques. ●

The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Performance Testing:

Engineering evaluations were conducted to verify that the performance of the World Knee system is is equal or better than the predicate device and therefore adequate for anticipated in-vivo use.

Substantial Equivalence:

The World Knee System has the same intended use, indications for use, materials and similar design as the Signature Orthopaedics Genius Knee System (K170613). The subject devices are expected to perform adequately during clinical use.

Comparison of technological characteristics

The following technological similarities exist between the subject and predicate devices:

. the World Knee incorporates the same materials as the Genius Knee
the World Knee has the same manufacturing process as the Genius Knee
. the World Knee has the same geometry and fundamental design as the Genius Knee
. the World Knee has the same body contact as the Genius Knee
the World Knee has the same sterilization process as the Genius Knee

The following technological differences exist between the subject and predicate devices:

. there are minor design differences in the femoral components, and meniscal insert component
an additional 2 intermediate sizes have been added

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.