Signature Orthopaedics Imboki Knee Instrument System are accessory devices intended to be used to assist the implantation of Signature Orthopaedics' World Total Knee System and its cleared 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 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.

Device Description

The Imboki Knee Instrument System is a simplified instrument set containing accessory devices that are intended to assist in the implantation of Signature Orthopaedics' previously cleared World Total Knee System (K180750).

The Imboki Knee Instrument System consists of manual orthopaedic surgical instruments which are either device-specific or non-device specific. The World Smart Card is a device-specific component which varies in geometry to match the specific dimensions of a particular sized World Knee component. It is a rectangular guide manufactured from acetal polymer as per ASTM F1855 which is assembled with the IM rod to assist with femoral alignment and distal resection. The Imboki Knee Instrument System also includes the same trial instruments as the World Knee previously cleared under 510(k) submission K180750 for the femoral, tibial and patella components. The non-device specific instruments are manufactured from 630 stainless steel as per ASTM A269 or 420 stainless steel as per ASTM F899. All instruments are supplied non-sterile.

AI/ML Overview

The provided text is a 510(k) summary for the Imboki Knee Instrument System, which is an accessory device intended to assist in the implantation of a previously cleared knee system. It explicitly states that clinical data is not required to support the safety and effectiveness of the Imboki Knee Instrument System. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way one might expect for a primary therapeutic or diagnostic device.

The basis for clearance is substantial equivalence to a predicate device (Signature Orthopaedics' World Total Knee System instruments, K180750). The document argues that this new instrument system falls within the scope of validation and verification conducted on the previously cleared system.

Because clinical data was not required for this submission, the following sections will be largely empty or marked as "Not applicable" based on the provided text's explicit statement.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified as clinical data was not required.	Not specified. The device's performance is assumed to be substantially equivalent to the predicate device based on its design, materials, and intended use.

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

Not applicable. Clinical test data was not required for this 510(k) submission. The device's substantial equivalence was based on its similarity to a predicate device.

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

Not applicable. Clinical test data was not required for this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. Clinical test data was not required for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to the provided text.

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

Not applicable. The Imboki Knee Instrument System is a set of manual orthopedic surgical instruments, not an algorithm or AI-driven device.

7. The Type of Ground Truth Used

Not applicable. Clinical performance data or ground truth for diagnostic accuracy was not required for this submission. The "ground truth" used for clearance was the established safety and effectiveness of the predicate device, to which the new device was demonstrated as substantially equivalent.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical instrument system, not an AI or machine learning model that requires a training set.

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

Not applicable. This device is a mechanical instrument system, not an AI or machine learning model that requires a training set with established ground truth.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue font.

January 17, 2019

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

Re: K181338

Trade/Device Name: Imboki Knee Instrument 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: October 19, 2018 Received: October 24, 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. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Image /page/1/Figure/5 description: The image shows the name Peter G. Allen -S. The text 'Digitally signed by Peter G. Allen -S' is also present. The date '2019.01.17' and time '16:20:47 -05'00'' are also included in the image.

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) K181338

Device Name Imboki Knee Instrument System

Indications for Use (Describe)

· 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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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2 510(K) SUMMARY

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device TradeName:	Imboki Knee Instrument System
Common Name:	Orthopaedic Surgical Instrumentation
Contact:	Dr. Declan BrazilManaging 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:	18 May, 2018
Classification:	Class II per CFR 888.3560: Knee Joint PatellofemorotibialPolymer/Metal/Polymer Semi-Constrained Cemented Prosthesisprosthesis (JWH)
Predicate Devices:	Primary Predicate• World Total Knee System (K180750)

Device Description:

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Indications for Use:

. 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.

Performance Testing:

Clinical data is not required to support the safety and effectiveness of the Imboki Knee Instrument System. The Imboki Knee Instrument System is considered to be substantially equivalent to Signature Orthopaedics' World Total Knee System instruments (K180750). There are no new issues which have been raised relating to safety or effectiveness of the subject devices. Therefore, the Imboki Knee Instrument System falls within the scope of validation and verification conducted on Signature Orthopaedics' previously cleared World Total Knee System.

Substantial Equivalence:

The Imboki Knee Instrument System is considered to be substantially equivalent to Signature Orthopaedics' World Total Knee System instruments (K180750). The Imboki Knee Instrument System has the same materials, manufacturing route, principle of operation, sterilisation procedure, indications for use and body contact as the World Knee instruments.

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.