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.

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

Device Description

The Active-X Knee system is a modular knee system consisting of a femoral component, a standard, ultracongruent and ultracongruent+ meniscal insert (anterior lip), 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. All variants of the meniscal insert and patella are manufactured from UHMWPE.

AI/ML Overview

This document, K160159, describes the Active-X Total Knee System, a knee replacement device. The regulatory submission primarily relies on demonstrating substantial equivalence to predicate devices through engineering evaluations rather than extensive new performance testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative format typical of a performance study. Instead, the "Performance Testing" section states that engineering evaluations were performed to demonstrate equivalent performance between the Active-X Knee System and the predicate device (dj Orthopedics Alaron Surgical Active Knee® System (K021740)).

The approach taken is that if the new components (ultracongruent+ meniscal insert and inlay patella) perform equivalently to existing similar components, then further testing is not required.

Acceptance Criteria (Implied)	Reported Device Performance
Equivalence in Range of Motion	Engineering evaluations showed the ultracongruent+ meniscal insert and inlay patella perform equivalently to the remainder of the Active-X Knee System and the predicate (dj Orthopaedics Alaron Surgical Active Knee System K021740). Therefore, further range of motion analysis was not required.
Equivalence in Modular Component Connection Strength	Engineering evaluations showed the ultracongruent+ meniscal insert and inlay patella perform equivalently to the remainder of the Active-X Knee System and the predicate. Therefore, further modular component connection strength testing was not required.
Equivalence in Component Contact Area and Stress	Engineering evaluations showed the ultracongruent+ meniscal insert and inlay patella perform equivalently to the remainder of the Active-X Knee System and the predicate. Therefore, further component contact area and stress testing was not required.
Equivalence in Component Constraint	Engineering evaluations showed the ultracongruent+ meniscal insert and inlay patella perform equivalently to the remainder of the Active-X Knee System and the predicate. Therefore, further component constraint testing was not required.
Equivalence in Wear Characteristics	Engineering evaluations showed the ultracongruent+ meniscal insert and inlay patella perform equivalently to the remainder of the Active-X Knee System and the predicate. Therefore, further wear testing was not required.
Equivalence in Cement Fixation	Engineering evaluations showed the ultracongruent+ meniscal insert and inlay patella perform equivalently to the remainder of the Active-X Knee System and the predicate. Therefore, further cement fixation testing was not required.
Overall Substantial Equivalence to Predicate Devices (K021740, K032683)	Claimed: The Active-X Knee System has the same intended use, indications for use, materials, and design as the Alaron Surgical Active Knee® System (K021740), with the ultracongruent+ meniscal insert having an increased anterior lip and the inlay patella having similar design features to the Genesis II Total Knee System Inlay Patella Component (K032683). Non-clinical testing results (engineering evaluations) support this claim.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not applicable (N/A). The document indicates that extensive physical testing for performance was "omitted" based on engineering evaluations. It refers to "engineering evaluations" rather than a clinical or biomechanical test set with a specific sample size.
Data provenance: Not explicitly stated, as no new primary performance testing data (e.g., from a test set of devices) is presented. The "engineering evaluations" would likely be laboratory-based analyses and comparisons to existing predicate device data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of experts: N/A. No external experts or ground truth establishment process for a test set is described. The "engineering evaluations" would have been conducted by the manufacturer's engineers.
Qualifications of experts: N/A.

4. Adjudication method for the test set:

Adjudication method: N/A. No adjudication method is mentioned as there was no test set requiring such a process.

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:

N/A. This device is a knee replacement system, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

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

N/A. This is a physical medical device (knee implant), not an algorithm or software.

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

Type of ground truth: N/A for new performance testing. The "ground truth" for the substantial equivalence claim is based on the established performance and safety profiles of the legally marketed predicate devices (dj Orthopedics Alaron Surgical Active Knee® System K021740 and Smith & Nephew Genesis II Knee System Inlay Patella Component K032683). The engineering evaluations aimed to show that the new components would perform comparably to these established devices.

8. The sample size for the training set:

N/A. This is a physical medical device, not a machine learning model.

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

N/A. This is a physical medical device, not a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

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

Re: K160159

Trade/Device Name: Active-X Total Knee 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: August 9, 2016 Received: August 12, 2016

Dear Dr. 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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

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1 INDICATIONS FOR USE STATEMENT

510(k) Number (if Known): K160159

Device Name: Active-X Total Knee System

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.

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

Prescription Use: Yes (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: No (Part 29 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(K) SUMMARY 2

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device Trade Name:	Active-X Total Knee System
Common Name:	Total Knee Prosthesis
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:	January 20th, 2015
Classification:	Knee joint patellofemorotibial polymer/metal/polymer semi-con-strained cemented prosthesis (JWH, 21CFR 888.3560)
Predicate Devices:	Substantial equivalence to the following device is claimed:• Primary Predicate: dj Orthopedics Alaron Surgical Ac-tive Knee® System (K021740)• Reference Predicate: Smith & Nephew Genesis II KneeSystem Inlay Patella Component (K032683)

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 Active-X Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Performance Testing:

Engineering evaluations were performed to demonstrate equivalent performance between the Active-X Knee System and the dj Orthopedics Alaron Surgical Active Knee® System (K021740). The Active-X Knee System is identical to the dj Orthopaedics Alaron Surgical Active Knee System (K021740) with the addition of the ultracongruent+ meniscal insert and inlay patella. Engineering evaluations have shown that the ultracongruent+ meniscal insert and inlay patella perform equivalently to the remainder of the Active-X Knee System and the dj Orthopaedics Alaron Surgical Active Knee System (K021740); therefore, further device testing is not required. The following testing has been omitted on the basis of the engineering evaluations:

. Range of motion analysis
. Modular component connection strength testing
. Component Contact Area and Stress Testing
Component Constraint Testing
. Wear Testing
. Cement fixation testing

Substantial Equivalence:

The Active-X Total Knee system devices have the same intended use, indications for use, materials and design to the Alaron Surgical Active Knee® System (K021740), excluding the ultracongruent+ meniscal insert and the inlay patella geometry. The ultracongruent+ meniscal insert features an increased anterior lip compared to the Alaron Surgical Active Knee ultracongruent meniscal to further compensate for a deficient PCL. The inlay patella has similar design features to the Genesis II Total Knee System Inlay Patella Component (K032683). The materials, function, intended use, and fundamental scientific technology remain the same. Non-clinical testing results support the substantial equivalence claim.

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.