2AYAJ-CTE1Med Radio Implant (CTE)

Manufactured for: Canary Medical, LLC. 2710 Loker Ave. West Suite 350 Carlsbad, CA 92010 www.canarymedical.com E-mail: [email protected] Customer Assistance: 1-800-123-9876 PN. K01-HBS-300003, Rev2 Page | 46 US Federal Communications Commission (FCC) •FCC ID: 2AYAJ-BS1 •This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. •This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. •IMPORTANT: Changes or modifications to this product not authorized by Canary Medical could void the FCC Certification and negate your authority to operate this product.

Physician Instructions for Use Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Canary Medical, Inc. Page | 1 TABLE OF CONTENTS 1. OVERVIEW OF THE CANARY TIBIAL EXTENSION WITH CHIRP SYSTEM....................5 2. ADDITIONAL REFERENCED DOCUMENTS .................................................................6 3. TERMS AND ACRONYMS .......................................................................................... 7 4. DEVICE SYSTEM DESCRIPTION ................................................................................. 9 4.1. The Canary Tibial Extension (CTE).......................................................................... 10 4.2. CTE Template ......................................................................................................... 12 4.3. CTE with CHIRP System Surgical Instrumentation ................................................. 12 4.3.1. Impaction Sleeve ............................................................................................ 12 4.3.2. Canary Tibia Cut Guide (5 Degree – L/R) ........................................................ 13 4.3.3. Canary Drill Bit ................................................................................................ 13 4.3.4. CTE Provisional ............................................................................................... 14 4.4. Base Station Systems ............................................................................................. 14 4.4.1. OR Base Station System .................................................................................. 15 4.4.2. Home Base Station System ............................................................................. 16 4.4.3. The Canary Medical Cloud Data Management Platform (Cloud) ................... 17 4.5. Physician Portal ...................................................................................................... 17 4.6. Patient Dashboard ................................................................................................. 20 5. INTENDED USE ....................................................................................................... 22 5.1. Intended Use .......................................................................................................... 22 5.2. Indications for Use .................................................................................................22 5.3. Users and Component Interfaces .......................................................................... 22 Physician Instructions for Use DRAFT Page | 2 6. LIMITATIONS .......................................................................................................... 26 7. CONTRAINDICATIONS............................................................................................26 8. MRICompatibility..................................................................................................27 9. GENERAL WARNINGSAND PRECAUTIONS.............................................................27 9.1. CTE.........................................................................................................................27 9.2. Surgical and Home Base Stations and Accessories (including Bar Code Scanners, Laptops, and cables) ...................................................................................................... 27 10. PRINCIPLES OF OPERATION ................................................................................... 28 10.1. Collection, Storage, and Transmission of the CTE Data .................................. 28 10.2. Canary Medical Gait Parameters Data Characteristics ................................... 29 11. DIRECTIONS FOR USE ............................................................................................. 30 11.1. Surgeon’s Office Patient Account Setup ......................................................... 31 11.1.1. Orthopedic Surgeon .................................................................................... 31 11.1.2. Surgeon’s Office Staff .................................................................................. 31 11.2. Patient Registration and Account Setup ......................................................... 33 11.2.1. Patient ......................................................................................................... 33 11.3. Home Base Station System Setup................................................................... 33 11.3.1. Patient ......................................................................................................... 33 11.4. Day of Surgery ................................................................................................ 34 11.4.1. Preoperative: CTE Implant Self-Test and Sensor Check ............................. 34 11.4.2. Intraoperative: Tibia Resection, Preparation, and Trialing ........................ 36 11.4.3. Intraoperative: Activate theCTE implant .................................................. 37 Physician Instructions for Use DRAFT Page | 3 11.4.4. Intraoperative: Connection of Canary CTE to Zimmer Biomet Tibial Baseplateand Implantation.........................................................................................37 11.4.5. Postoperative: Link the CTE implant and Knee Prosthesis Components to the Patient 39 11.5. HCP.................................................................................................................. 39 11.5.1. Patient ......................................................................................................... 39 12. ADVERSE EVENTS ................................................................................................... 40 13. COMPATIBILITY WITH OTHER DEVICES .................................................................. 40 14. COMPONENT SPECIFICATION…

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June 16, 2021 Nemko Canada Inc. 303 River Road Ottawa, ON Canada K1V 1H2 REQUEST FOR CONFIDENTIALITY FOR FCC Name of Applicant: Canary Medical USA LLC Address: 2710 Loker Ave West, Suite 350 City: Carlsbad, CA 92010 Country: USA FCC ID: 2AYAJ-BS1, 2AYAJ-CTE Pursuant to Sections 0.457(d) and 0.459 of the commission’s rules and Industry of Canada Regulations, we hereby request that the following documents be held under long term confidentiality. Short Term Confidentiality for 180 days 1. Test Setup Photographs 2. External Photos Permanent Confidentiality: 1. Schematics 2. Bill of Materials 3. Block Diagram 4. Operational Description 5. Internal Photos These Materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. These devices are available only to trained health care providers or patients under a doctor’s prescription, and internal circuitry is not accessible to users. Dated: 16-JUNE-2021 Signed: _____________________ Printed: Peter Schiller Title: Sr. Vice President, Research & Development

Canturio™ - TE Tibial Extension 14mm (D) X 58mm (H) Persona ® IQ The Personalized Knee (833) 722-6279 123456 2020-01-01 2022-12-31 *+22365123456A20MS* (01)00860003118306 (17)221231 (21)123456 43-5570-058-14 IPX7 FCC ID: 2AYAJ-CTE1 *+H124435570058141M* K01-CTE-300001 Rev. A (833) 722-6279 www.canarymedical.com CANARY MEDICAL 43-5399-058-14 A Canturio™ - TE Persona ® IQ The Personalized Knee Tibial Extension 123456 2020-01-01 2022-12-31 *+H124435570058141M* *+22365123456A20MS* (01)00860003118306 (17)221231 (21)123456 Made in USA FCC ID: 2AYAJ-CTE1 (833) 722-6279 www.canarymedical.com CANARY MEDICAL 43-5399-058-14 A Canturio™ - TE Persona ® IQ The Personalized Knee Tibial Extension 123456 2020-01-01 2022-12-31 *+H124435570058141M* *+22365123456A20MS* (01)00860003118306 (17)221231 (21)123456 Made in USA FCC ID: 2AYAJ-CTE1 Canturio™ - TE Tibial Extension 14mm (D) X 58mm (H) Persona ® IQ The Personalized Knee (833) 722-6279 123456 2020-01-01 2022-12-31 *+22365123456A20MS* (01)00860003118306 (17)221231 (21)123456 43-5570-058-14 IPX7 FCC ID: 2AYAJ-CTE1 *+H124435570058141M* K01-CTE-300001 Rev. A

This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. Canary Medical CTE Implant FCC 95I:2020 MedRadio Report: CAAL0012.1, Issue Date: October 14, 2020 NVLAP LAB CODE: 200676-0 CERTIFICATE OF TEST 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing. Last Date of Test: October 12, 2020 Canary Medical EUT: CTE Implant Radio Equipment Testing Standards Specification Method FCC 95I:2020 ANSI C63.26:2015, ANSI C63.4:2014 Results Method Clause Test Description Applied Results Comments ANSI C63.26 5.4.3 Emission Bandwidth Yes Pass FCC 95.2579(a)(1) Emission Mask Yes Pass ANSI C63.26 5.2.3.3 Duty Cycle Characterization Yes Pass ANSI C63.26 5.2.3.3 Conducted Output Power Yes Pass ANSI C63.26 5.6 Frequency Stability Yes Pass ANSI C63.26 5.5.4 Spurious Radiated Emissions Yes Pass ANSI C63.26 5.7 Spurious Conducted Emissions Yes Pass ANSI C63.26 5.2.3.3, 5.2.7 Radiated Power (EIRP) Yes Pass Deviations From Test Standards None Approved By: Victor Ratinoff, Operations Manager Report No. CAAL0012.12/36 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. CAAL0012.13/36 ACCREDITATIONS AND AUTHORIZATIONS 2019.03.08 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC 17065 as a product certifier. This allows Element to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Within Element, we have a EU Notified Body validated for the EMCD and RED Directives. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: https://www.nwemc.com/emc-testing-accreditations Report No. CAAL0012.14/36 FACILITIES 2019.03.08 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-10 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 NVLAP NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200630-0 NVLAP Lab Code:201049-0 NVLAP Lab Code: 200629-0 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. CAAL0012.15/36 MEASUREMENT UNCERTAINTY TMU.2015.07.10 Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document QM205.4.6. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) can be found included as part of the applicable test description page. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-2 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (M…

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XMit 2020.03.25.0 IMG_0504.JPG IMG_0505.JPG DIRECT CONNECT XMit 2020.03.25.0 IMG_0506.JPG DIRECT CONNECT photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 IMG_1834.JPG SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 IMG_0523.JPG IMG_0525.JPG _0525 SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 IMG_1835.JPG IMG_1837.JPG SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 IMG_0518.JPG IMG_0519.JPG _0519 RADIATED POWER (EIRP) photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 IMG_0520.JPG IMG_0521.JPG _0521 RADIATED POWER (EIRP) photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 IMG_0523.JPG IMG_0524.JPG _0524 RADIATED POWER (EIRP) photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 IMG_0525.JPG IMG_0526.JPG _0526 RADIATED POWER (EIRP)