EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

K202270 · K1 Medical, LLC · KCT · Dec 2, 2020 · General Hospital

Device Facts

• Record ID: K202270
• Device Name: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
• Applicant: K1 Medical, LLC
• Product Code: KCT · General Hospital
• Decision Date: Dec 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

Device Story

Sterilization cassette/tray system; organizes, encloses, transports, and stores Stryker Mako Total Knee with Triathlon surgical instruments (impactors, trials, MICS, sagittal saws, arrays) between surgical procedures. Used in healthcare facilities; operated by sterile processing staff. Device consists of perforated anodized aluminum trays, stainless steel handles, and thermoplastic polymer posts. Not a sterile barrier; requires use with an FDA-cleared sterile barrier system. Protects instruments during transport and storage; withstands repeated steam sterilization cycles. Benefits include organized instrument management and protection of surgical tools during reprocessing workflows.

Clinical Evidence

Bench testing only. Validations included material compatibility (25 cycles), mechanical cleaning efficacy (hemoglobin <2.2 µg/cm², protein <6.4 µg/cm²), sterilization validation (SAL 10^-6), thermal profiling, drying time, and handle strength (50 lbs force). Testing confirmed the device achieves SAL 10^-6 for the specified Stryker Mako Triathlon instrument sets.

Technological Characteristics

Materials: Anodized aluminum, stainless steel, medical-grade thermoplastic polymers. Design: Perforated base and lid with locking latch. Sterilization: Steam (Dynamic Air Removal, 270°F/132°C, 4 min exposure, 10 min dry). Standards: AAMI TIR12, AAMI ST81, ISO 17665-1, AAMI TIR30, ASTM F32018, ASTM F3293, ISO 10993-5, AAMI ST77, AAMI ST8. Connectivity: None. Form factor: Tray system.

Indications for Use

Indicated for use in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon surgical instruments between uses. Not intended to maintain sterility independently; must be used with an FDA-cleared sterile barrier system.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• EZ-TRAX™ Containment Device (K192487)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

December 2, 2020

K1 Medical LLC % Joseph Azary Regulatory Consultant / Application Correspondent Joseph Azary 543 Long Hill Avenue Shelton, Connecticut 06484

Re: K202270

Trade/Device Name: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: October 30, 2020 Received: November 6, 2020

Dear Joseph Azary:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,

Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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| 510(k) Number ( <i>if known</i> ) | K202270 |
|-----------------------------------|---------|
|-----------------------------------|---------|

Device Name

#### EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device

Indications for Use (Describe)

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

| Cycle | Temperature | Exposure Time | Drying Time |
|---------------------|-------------|---------------|-------------|
| Dynamic Air Removal | 270 F/132 C | 4 minutes | 10 minutes |

Sterilization validations included the worst case load configurations of the EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.

- . Contents in the validated configuration include: reusable surgical instruments (impactors, trials, , MICS, sagital saws, arrays, etc.)
- . No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims
- Healthcare facilities should not exceed 25 pounds (EZ- TRAX™ Containment Device + sterile barrier
system + Stryker Mako Total Knee with Triathlon Containment devices).

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes:

| Brand Name | Model | Dimensions |
|------------|------------------------|----------------------------------|
| EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | L) 22.97" (W) 11.18" (H) 2.44" |
| EZ-TRAX™ | BASE.ASSY.AL.21.12.4 | (L) 19.97" (W) 11.18" (H) 4.187" |

Type of Use (Select one or both, as applicable)

□ Prescription Use (Part 21 CFR 801 Subpart D)

区 Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) SUMMARY

## K1 Medical LLC's EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device

### K202270

#### Submitter

K1 Medical LLC 56 Newton Road Woodbridge, CT 06525

Contact Person: Joseph Azary, Requlatory Consultant

Phone: [phone] Date Prepared: November 24, 2020

Name of Device: EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device

Common or Usual Name: Sterilization Cassette

Classification Name: Sterilization Wrap Regulatory Class: Class II, 21 CFR 880.6850

Product Code: KCT

#### Predicate Device:

EZ-TRAX™ Containment Device, K1 Medical, K192487

#### Device Description

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store Stryker Mako Total Knee with Triathlon Devices between surgical uses.

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, FDA cleared sterile barrier system.

The subject device protects the interior components during transportation, and storage.

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers.

The lids and bottom of trays are fully perforated with an evenly distributed hole pattern. The sides of the trays are partially perforated. The trays are used with locking lids.

The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.

510(k) Summary Page 1 of 8

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#### Intended Use / Indications for Use

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

| Cycle | Temperature | Exposure Time | Drying Time |
|---------------------|-------------|---------------|-------------|
| Dynamic Air Removal | 270 F/132 C | 4 minutes | 10 minutes |

Sterilization validations included the worst case load configurations of the EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.

- -Contents in the validation configuration include: reusable surgical instruments (impactors, trials, MICS, sagittal saws, arrays, etc).
- -No lumended devices were validated within the tray system as part of the product load. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims.
- Healthcare facilities should not exceed 25 pounds (EZ-TRAX™) Containment Device + sterile barrier system + Stryker Mako Total Knee with Triathlon containment devices).

The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes: .

| Brand Name | Model | Dimensions |
|------------|------------------------|----------------------------------|
| EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | (L) 22.97" (W) 11.18" (H) 2.44" |
| EZ-TRAX™ | BASE.ASSY.AL.21.12.4 | (L) 19.97" (W) 11.18" (H) 4.187" |

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# Summary of Technological Characteristics

Provided below is a comparison of the subject device to the predicate device.

## Technological Characteristics Comparison Table

| TRADENAME | K1 Medical LLC<br>EZ-TRAX™ Stryker<br>Mako Total Knee with<br>Triathlon Containment<br>Device<br>K202270 | K1 Medical LLC<br>EZ-TRAX™<br>Containment Device<br>K192487 | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental<br>Scientific<br>Technology | Sterilization Cassette | Sterilization Cassette | Identical |
| Product Code | KCT | KCT | Identical |
| Material<br>Composition | Thermoplastic polymers,<br>Aluminum, and stainless<br>steel | Thermoplastic<br>polymers, Aluminum,<br>and stainless steel | Identical |
| Design | Base, lid with locking latch<br>and individual inserts | Base, lid with locking<br>latch and individual<br>inserts | Identical |
| Dimensions | Worst case 24 x 12 x 4" | Worst case 24 x 12 x 4" | Identical |
| Configuration | Perforated bases, lids<br>and inserts | Perforated bases, lids<br>and inserts | Identical |
| Air Permeance | Yes | Yes | Identical |
| Percent<br>Perforation | Evenly distributed hole<br>pattern | Evenly distributed hole<br>pattern | Identical |
| Sterilization<br>Method | Dynamic Air Removal | Dynamic Air Removal | Identical |
| Sterilization<br>Parameters | Dynamic Air Removal<br>Temperature: 270F<br>Exposure Time: 4 minutes<br>Drying Time: 10 minutes | Dynamic Air Removal<br>Temperature: 270F<br>Exposure Time: 4 minutes<br>Drying Time: 10 minutes | Identical |
| Reusable | Yes | Yes | Identical |
| Microbial<br>Barrier<br>Properties | Used with FDA approved<br>sterile barrier system | Used with FDA<br>approved sterile barrier<br>system | Identical |
| Material<br>Compatibility | Materials compatible with<br>sterilization method | Materials compatible<br>with sterilization<br>method | Identical |
| Toxicological | Biocompatible | Biocompatible | Identical |
| Intended Use/<br>Indications for<br>Use | The EZ-TRAXTM Stryker<br>Mako Total Knee with<br>Triathlon Containment<br>Device is intended for use<br>as an accessory in<br>healthcare facilities to<br>organize, enclose,<br>reprocess, transport, and<br>store Stryker Mako Total<br>Knee with Triathlon<br>devices between surgical<br>uses. The EZ-TRAXTM<br>Stryker Mako Total Knee<br>with Triathlon<br>Containment Device is not<br>intended on its own to<br>maintain sterility; it is<br>intended to be used in<br>conjunction with a legally<br>marketed, validated, FDA-<br>cleared sterile barrier<br>system. | The EZ-TRAXTM<br>Containment Device is<br>intended for use as an<br>accessory in healthcare<br>facilities to organize,<br>enclose, reprocess,<br>transport, and store<br>medical devices between<br>surgical and other<br>medical uses. The EZ-<br>TRAXTM Containment<br>Device is not intended<br>on its own to maintain<br>sterility; it is intended to<br>be used in conjunction<br>with a legally marketed,<br>validated, FDA-cleared<br>sterile barrier system.<br><br>Cycle: Dynamic Air<br>Removal<br>Temperature: 270F /<br>132C<br>Exposure Time: 4<br>minutes<br>Drying Time: 10 minutes<br><br>Sterilization validations<br>included a worst case<br>EZ-TRAXTM<br>Containment Device and<br>a medical device<br>challenge set comprising<br>of:<br>- Lumen<br>dimensions (3)<br>1mm x 500mm<br>- Conjoined/mated<br>surfaces:<br>forceps, clamps,<br>bending pliers,<br>ratchet handles,<br>retractors<br>- Cannulated: drill<br>bits, taps,<br>guides,<br>screwdrivers,<br>cannulated<br>screws<br>- A total weight of<br>42 lbs<br>comprising of<br>(EZ-TRAXTM<br>Containment | The subject device has specific<br>indications for use with the<br>Stryker Mako Total Knee with<br>Triathlon Containment device.<br><br>The parameters including cycle,<br>temperature, exposure time, and<br>drying time are identical with no<br>difference.<br><br>The contents and load<br>configurations of the subject<br>device are different because they<br>are specific to the Stryker Mako<br>Total Knee with Triathlon<br>Containment device. |
| | Cycle: Dynamic Air<br>Removal<br>Temperature: 270F/132C<br><br>Exposure Time: 4<br>minutes<br>Drying Time: 10 minutes<br><br>The validated worst case<br>load configurations of the<br>EZ- TRAXTM Stryker<br>Mako Total Knee with<br>Triathlon Containment<br>Device were utilized. | | |
| | Brand Name<br>Model<br>Dimensions | | |
| | EZ-TRAXTM (L) 22.97"<br>BASE.ASSY. (W) 11.18"<br>AL.24.12.2.4 (H) 2.44" | | |
| | EZ-TRAXTM (L) 19.97"<br>BASE.ASSY. (W) 11.18"<br>AL.21.12.4 (H) 4.187" | | |

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| - Contents in the<br>validated configuration<br>include: reusable surgical<br>instruments (impactors,<br>trials, , MICS, sagital<br>saws,.arrays, etc.)<br>- No lumened devices<br>were validated within the<br>tray system as part of the<br>product load. The EZ-<br>TRAX™ Stryker Mako<br>Total Knee with Triathlon<br>Containment Device does<br>not have any lumen<br>claims. | Device + sterile<br>barrier system +<br>medical device<br>load) as a worst<br>case challenge<br>to the system.<br>Healthcare<br>facilities should<br>not exceed 25<br>pounds (EZ-<br>TRAX™<br>Containment<br>Device + sterile<br>barrier system +<br>medical device<br>load).<br><br>The EZ-TRAX™ is<br>offered in the following<br>sizes:<br><br>Brand        Model<br>Name        Dimensions<br>EZ-TRAX™ (L) 22.97"<br>BASE.ASSY (W) 11.18"<br>AL.12.12.2 (H) 2.04"<br><br>EZ-TRAX™ (L) 22.97" |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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## Summary of Nonclinical Testing

Provided below is a summary table of the non-clinical testing that were performed using the subject device. The result demonstrated that the subject device nonclinical test results met the acceptance criteria of the standards.

| Test / | Purpose | Acceptance Criteria | Results |
|---------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | | | |
| AAMI TIR12:2010<br>AAMI<br>ST81:2004/R2016<br>ISO 17665-<br>1:2006/R2013 | Material<br>Compatibility | Verify no degradation or lack<br>of functionality after repetitive<br>cleaning and sterilization<br>processing for 25 cycles. | Material compatibility<br>pre-vacuum 132C for 4<br>minutes - Mechanical<br>Washing and Steam<br>Sterilization<br>The testing subjected<br>the device to repetitive<br>cleaning and<br>sterilization processing<br>for 25 reprocessing<br>cycles at parameters<br>that represented the<br>worst case conditions. |
| AAMI TIR12:2010<br>AAMI<br>ST81:2004/R2016<br>ISO 17665-<br>1:2006/R2013 | | | Chemical indicators<br>were utilized to<br>demonstrate steam<br>penetration. The study<br>found no degradation<br>or lack of functionality<br>after 25 cycles. |
| AAMI TIR30:2011<br>ASTM F32018-18<br>ASTM F3293-18 | Mechanical<br>Cleaning Validation<br>- Hemoglobin | Verify cleaning instructions<br>provided are efficacious for<br>removing gross amounts of<br>soil to a hemoglobin level<br>less than 2.2 µg/cm2 per<br>device. | The mechanical cleaning<br>validation of the EZ-<br>TRAX™ containment<br>system concluded that the<br>manufacturer's cleaning<br>instructions are<br>efficacious for removing<br>gross amounts of soil from<br>the EZ-TRAX™<br>containment system to a<br>hemoglobin level less<br>than 2.2 µg/cm2 per<br>device. |
| AAMI TIR30:2011<br>ASTM F32018-18<br>ASTM F3293-18 | Mechanical<br>Cleaning Validation<br>- Protein Analysis | Verify cleaning instructions<br>provided are efficacious for<br>removing gross amounts of<br>soil to a protein level less<br>than 6.4 µg/cm2 per device. | The mechanical cleaning<br>validation of the EZ-<br>TRAX™ containment<br>system protein concluded<br>that the manufacturer's<br>cleaning instructions are |
| | | | efficacious for removing<br>gross amounts of soil from<br>the EZ-TRAX™<br>containment system to a<br>protein level less than 6.4<br>ug/cm2 per device. |
| ISO 10993-5:2009<br>/ R2014 | MEM Elution<br>Cytotoxicity | Verify the device does not<br>have a cytotoxic potential. | The cytotoxicity testing<br>was conducted per ISO<br>10993-5:2009/(R)2014<br>and concluded that test<br>articles met the<br>requirements of the test<br>and are NOT considered<br>to have a cytotoxic<br>potential. |
| AAMI ST77:2013<br>ISO 14937:2009<br>AAMI ST8:2013 | Sterilization<br>Validation | Verify the device and cycle<br>parameters achieve a<br>Sterility Assurance Level of<br>10-6. | The sterilization validation<br>of the EZ-TRAX™<br>containment system<br>included pre-vacuum<br>steam 132C for 4 minutes.<br>The conclusion could<br>achieve a Sterility<br>Assurance Level (SAL) of<br>10-6 after processing in<br>the following pre-vacuum<br>steam sterilization cycle<br>132C for 4 minutes. |
| AAMI ST77:2013 | Thermal Profile<br>Study | Verify the device and cycle<br>parameters demonstrate that<br>adequate sterilant<br>penetration is achieved. | The thermal profile study<br>of the EZ-TRAX™<br>Containment Device<br>included pre-vacuum<br>steam 132C for 4 minutes.<br>The study demonstrated<br>that adequate sterilant<br>penetration can be<br>achieved. The EZ-<br>TRAX™ Containment<br>Device can reach and<br>maintain a steady state<br>thermal conditions<br>throughout the exposure<br>phase when processed in<br>the following pre-vacuum<br>steam sterilization cycle<br>132C for 4 minutes. |
| AAMI ST77:2013<br>ISO 17665-<br>1:2006/R 2013 | Drying Time Test | Verify the device is properly<br>dried using the specified<br>cycle parameters. | The results demonstrate<br>EZ-TRAX™ meets or<br>exceeds the minimum<br>acceptance criteria for dry<br>time. The EZ-TRAX™ is<br>considered properly dried<br>following processing in the<br>steam pre-vacuum<br>sterilization cycle of 132 C<br>/ 270F, Exposure Time<br>4.0 minutes, and Dry Time<br>10.0 minimum. |
| AAMI ST77:2013 | Handle 100 lbs<br>force test | Verify the handles do not<br>show evidence of permanent<br>distortion, cracking, or other<br>evidence of failure when<br>tested with a force of 50 lbs. | None of the tray handles<br>broke loose showed<br>evidence of permanent<br>distortion, cracking, or<br>other evidence of failure<br>when tested with force of<br>50 lbs. |
| AAMI ST8:2013<br>TIR12:2010<br>ST77:2013/R2018<br>ISO<br>14937:2009/R2013<br>ISO 17665-<br>1:2006/R2013 | Sterilization<br>Validation of the<br>Stryker Mako<br>Triathlon Instrument<br>Set #1 with MICS<br>with EZ-TRAX™ | Verify that the device with<br>instrument set specific to<br>device and specified cycle<br>parameters achieve a<br>Sterility Assurance Level of<br>10-6. | The testing verified that a<br>Sterility Assurance Level<br>of 10-6 can be achieved<br>after processing Stryker<br>Mako Triathlon Instrument<br>Set #1 with MICS in a<br>steam pre-vacuum cycle<br>at 132C and 4 minutes. |
| AAMI ST77:2013<br>ISO<br>14937:2009/R2013<br>ISO 17665-<br>1:2006/R2013 | Sterilization<br>validation of Stryker<br>Mako Triathlon<br>Universal TKA with<br>EZ-TRAX™ | Verify that the device with<br>implants specific to device<br>and specified cycle<br>parameters achieve a<br>Sterility Assurance Level of<br>10-6. | The testing verified that a<br>Sterility Assurance Level<br>of 10-6 can be achieved<br>after processing Stryker<br>Mako Triathlon Universal<br>TKA01 and TKA03 in a<br>steam pre-vacuum cycle<br>at 132C and 4 minutes. |

Non-Clinical Performance Testing Table

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### Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is as safe, as effective, and performs as well as or better than the legally marketed EZ-TRAX™ Containment Device.