Who can help prepare an FDA 510(k) submission like EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device

Q: Who is the manufacturer of EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

K1 Medical, LLC filed the 510(k) submission for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device (K213209).

Q: What is the FDA product code for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

KCT. It is classified under 21 CFR 880.6850 as a Class 2 device in the General Hospital panel.

Q: What is the regulatory pathway for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device?

EZ-TRAX™ Persona Knee Containment Device (K211007).

K213209 · K1 Medical, LLC · KCT · Dec 28, 2021 · General Hospital

Device Facts

Record ID	K213209
Device Name	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
Applicant	K1 Medical, LLC
Product Code	KCT · General Hospital
Decision Date	Dec 28, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6850
Device Class	Class 2

Intended Use

The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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

The EZ-TRAX™ is a sterilization cassette (tray system) used in healthcare facilities to organize and protect reusable surgical instruments (e.g., impactors, trials, reamers, broaches) during steam sterilization, transport, and storage. The device consists of a perforated anodized aluminum base and lid with stainless steel handles, aluminum dividers, and medical-grade thermoplastic polymer posts. It is not a sterile barrier itself and must be used with an FDA-cleared sterile barrier system. The device is processed in standard hospital autoclaves using dynamic air removal steam sterilization (270°F/132°C for 4 minutes). It protects internal components from damage and facilitates sterilant penetration through its perforated design. Healthcare providers use the tray to manage instrument sets, ensuring they are properly cleaned and sterilized before surgical procedures. The system supports safe handling and organization of orthopedic instrument sets, reducing the risk of damage during reprocessing cycles.

Clinical Evidence

No clinical data. Bench testing only. Validations included material compatibility (25 cycles), mechanical cleaning efficacy (hemoglobin <2.2 ug/cm2, protein <6.4 ug/cm2), MEM elution cytotoxicity, sterilization validation (SAL 10^-6), thermal profile, drying time, and mechanical handle strength (50 lbs force).

Technological Characteristics

Materials: Anodized aluminum, stainless steel, medical-grade thermoplastic polymers. Design: Perforated base/lid with locking latch. Sterilization: Dynamic air removal steam (132°C/270°F). Standards: AAMI ST77, AAMI ST8, AAMI TIR12, AAMI TIR30, ISO 10993-5, ISO 14937, ISO 17665-1, ASTM F32018, ASTM F3293. Connectivity: None (standalone).

Indications for Use

Indicated for use in healthcare facilities to organize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System reusable surgical instruments between surgical uses. Not intended to maintain sterility independently; must be used with an FDA-cleared sterile barrier system. Not for use with lumened devices.

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™ Persona Knee Containment Device (K211007)

Related Devices

K192487 — EZ-TRAX Containment Device · K1 Medical, LLC · Dec 23, 2019
K211007 — EZ-TRAXTM Persona Knee Containment Device · K1 Medical, LLC · Jul 1, 2021
K241927 — Synthes Graphic Case & Tray System · Synthes GmbH · Mar 28, 2025
K131455 — RESTORE MODULAR STERILIZATION TRAY SYSTEM · Restore Medical Solutions, Inc. · Aug 30, 2013
K102103 — SKELETAL DYNAMICS STERILIZATION TRAYS · Skeletal Dynamics, LLC · Dec 7, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 28, 2021 K1 Medical LLC % Joseph Azary Consultant Joseph Azary 543 Long Hill Avenue Shelton, Connecticut 06484 Re: K213209 Trade/Device Name: EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: September 27, 2021 Received: September 29, 2021 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 {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Clarence Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213209 #### Device Name EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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 | Validations included the worst case load configurations of the EZ- TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Devices. - . Contents in the validated configuration include reusable surgical instruments (impactors, trials, acetabular reamers, broaches, etc) - No lumened devices were validated within the tray system as part of the product load. The EZ-. TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims. - Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + Sterile Barrier . System + Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices). The EZ- TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is offered in the following size: | Brand Name | Model | Dimensions | Dry Weight | |------------|------------------------|--------------------------------|------------| | EZ-TRAX™ | BASE.ASSY.AL.24.12.2.4 | L) 22.97" (W) 11.18" (H) 2.44" | 4.25 lbs | Type of Use (Select one or both, as applicable) 7 Prescription Use (Part 21 CFR 801 Subpart D) y Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) SUMMARY K1 Medical LLC's EZ-TRAX Containment Device K213209 #### Submitter K1 Medical LLC 56 Newton Road Woodbridge, CT 06525 Contact Person: Joseph Azary Phone: 203-242-6670 Date Prepared: December 23, 2021 Name of Device: EZ-TRAXTM Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device Common or Usual Name: Sterilization Cassette Classification Name: Sterilization Wrap Regulatory Class: Class II, 21 CFR 880.6850 Product Code: KCT ### II. PREDICATE DEVICE: EZ-TRAX™Persona Knee Containment Device K211007 ### III.DEVICE DESCRIPTION The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store G7 Acetabular System / Taperloc Complete Hip System Devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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. {5}------------------------------------------------ The subject device protects the inteterior components during transportation, sterilization, and storage. The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System 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 travs are fully perforated with an evenly distributed hole pattern. The sides of the travs are partially perforated. The travs 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. #### IV. INTENDED USE / INDICATIONS FOR USE The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to orqanize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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 | Validations included the worst case load configurations of the EZ-TRAXTM Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices. - Contents in the validation configuration include: reusable surgical instruments -(impactors, trials, acetabular reamers, broaches, etc). - No lumended devices were validated within the tray system as part of the product load. - {6}------------------------------------------------ The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims. Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + sterile barrier system + Zimmer G7 Acetabular System / Taperloc Complete Hip System containment devices). The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is offered in the following sizes: | Brand Name | Model | Dimensions | Dry Weight | |------------|------------------------|------------------------------------|------------| | EZ-TRAX™ | Base.Assy.AL.24.12.2.4 | (L) 22.97" (W) 11.18" (H) 2.44" | 4.25 lbs | {7}------------------------------------------------ ### VII. TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE PROVIDED BELOW IS A TECHNOLOGICAL COMPARISON OF THE SUBJECT DEVICE TO THE PREDICATE DEVICE. | TRADENAME | K1 Medical LLC EZ-TRAXTM Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device K213209 | K1 Medical LLC EZ-TRAXTM Persona Knee Containment Device K211007 | Comparison | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Fundamental Scientific Technology | Sterilization Cassette | Sterilization Cassette | Identical | | Product Code | KCT | KCT | Identical | | Material Composition | Thermoplastic polymers, Aluminum, and stainless steel | Thermoplastic polymers, Aluminum, and stainless steel | Identical | | Design | Base, lid with locking latch, and individual inserts | Base, lid with locking latch and individual inserts | Identical | | Dimensions | Worst Case 24 x 12 x 2.4" | Worst case 24 x 12 x 2.4" | Identical | | Configuration | Perforated bases, lids, and inserts | Perforated bases, lids and inserts | Identical | | Air Permeance | Yes | Yes | Identical | | Percent Perforation | Evenly distributed hole pattern | Evenly distributed hole pattern | Identical | | Sterilization Method | Dynamic Air Removal | Dynamic Air Removal | Identical | | Sterilization Parameters | Dynamic Air Removal Temperature: 270F Exposure Time: 4 minutes Drying Time: 10 minutes | Dynamic Air Removal Temperature: 270F Exposure Time: 4 minutes Drying Time: 10 minutes | Identical | | Reusable | Yes | Yes | Identical | | Microbial Barrier | Used with FDA cleared sterile barrier system | Used with FDA cleared sterile barrier system | Identical | | Material Compatibility | Materials compatible with sterilization method | Materials compatible with sterilization method | Identical | | Biocompatibility | Biocompatible | Biocompatible | Identical | | Intended Use/ Indications for Use | | | | | | The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System 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: Dynamic Air Removal Temperature: 270 F/132 C Exposure Time: 4 minutes Drying Time: 10 minutes Validations include the worst case load configurations of the EZ-TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices. - Contents in the validated configuration include: reusable surgical instruments (impactors, trials, acetabular reamers, broaches, etc.). - No lumened devices were validated within the tray system as part of the product load. The EZ-TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims. -Healthcare facilities should not exceed 25 pounds (EZ-TRAXTM Containment Device + sterile barrier | The EZ-TRAX TM Persona Knee Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Persona Knee Devices between surgical uses. The EZ- TRAX TM Persona Knee 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: Dynamic Air Removal Temperature: 270 F/132 C Exposure Time: 4 minutes Drying Time: 10 minutes Sterilization validations included the worst case load configurations of Persona Knee Containment Device utilized the Persona Knee 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 TM Persona Knee Containment Device does not have any lumen claims. -Healthcare facilities should not exceed 25 pounds (EZ-TRAXTM Containment Device + sterile barrier system + Persona Knee Containment Devices). | Same | {8}------------------------------------------------ {9}------------------------------------------------ | system + Zimmer G7 Acetabular | | |------------------------------------------|--| | System / Taperloc Complete Hip | | | | | | System Devices). | | | | | | | | | The EZ-TRAX™ Zimmer G7 | | | Acetabular System / Taperloc | | | Complete Hip System Containment | | | | | | Device is offered in the following size: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | {10}------------------------------------------------ | EZ-TRAX™ BASE.ASSY.AL.24.12.2.4 (L) 22.97" (W) 11.18" (H) 2.44" Dry weight 4.25 lbs. | The EZ-TRAX™ Persona Knee 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" (Dry Weight 4.25 lbs). EZ-TRAX™ BASE.ASSY.AL.21. 12.4 (L) 19.97" (W) 11.18" (H) 4.187" | | |--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| |--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| ## Summary of Non-Clinical Testing Provided below is the summary of the non-clinical testing that was performed per specification of the standard and test methodology listed below. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodology. {11}------------------------------------------------ #### NON-CLINICAL PERFORMANCE TESTING TABLE VIII. | Test Methodology | Purpose | Acceptance Criteria | Results | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Material Compatibility AAMI TIR12:2010 AAMI ST81:2004/R2016 ISO 17665-1:2006/R2013 | To verify the device did not degrade or lose functionality after 25 reprocessing cycles at worst case conditions. | Material compatibility pre-vacuum 132C for 4 minutes. Mechanical Washing and Steam Sterilization The testing subjected the device to repetitive cleaning and sterilization processing cycles at parameters that represented worst case conditions. Chemical indicators were utilized to demonstrate steam penetration. The study found no degradation or lack of functionality after 25 cycles. | Passed | | Mechanical Cleaning Validation - Hemoglobin** AAMI TIR30:2011 ASTM F32018-18 ASTM F3293-18 | To verify the manufacturer's cleaning instructions are effective for removing gross amounts of soil to a hemoglobin level less than 2.2 ug/cm2 per device. | The mechanical cleaning validation of the EZ-TRAX™ containment system concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ-TRAX™ containment system to a hemoglobin level less than 2.2 ug/cm2 per device. | Passed | | Mechanical Cleaning Validation - Protein Analysis** AAMI TIR30:2011 ASTM F32018-18 ASTM F3293-18 | To verify the manufacturer's cleaning instructions are effective for removing gross amounts of soil to a protein level of less than 6.4 ug/cm2 per device. | The mechanical cleaning validation of the EZ-TRAX™ containment system protein concluded that the manufacturer's cleaning instructions are efficacious for removing gross amounts of soil from the EZ-TRAX™ containment system to a protein level less than 6.4 ug/cm2 per device. | Passed | | MEM Elution Cytotoxicity ISO 10993-5:2009 / R2014 | To verify that the device meets requirements of ISO 10993-5 and is not considered cytotoxic. | The cytotoxicity testing was conducted per ISO 10993-5:2009 /R2014 and concluded that test articles met the requirements of the test and are NOT considered to have a cytotoxic potential. | Passed | | Sterilization Validation AAMI ST77:2013 ISO 14937:2009 AAMI ST8:2013 | To verify that the device could achieve a sterility assurance level of 10-6 after processing in pre-vacuum steam sterilization cycle of 132C (270F) for 4 minutes. | The sterilization validation of the EZ-TRAX™ Containment System included pre-vacuum steam 132C for 4 minutes. The conclusion is the device could achieve a Sterility Assurance Level (SAL) of 10-6 after processing in the following pre-vacuum steam sterilization cycle 132C (270F) for 4 minutes. | Passed | | Thermal Profile Study AAMI ST77:2013 | To verify that adequate sterilant penetration can be achieved when processed in pre-vacuum steam sterilization cycle of 132C (270F) for 4 minutes. | The thermal profile study of the EZ-TRAX™ Containment Device included pre-vacuum steam 132C for 4 minutes. The study demonstrated that adequate sterilant penetration can be achieved. The EZ-TRAX™ Containment Device can reach and maintain a steady state thermal conditions throughout the exposure phase when processed in the following pre-vacuum steam sterilization cycle 132C (270F) for 4 minutes. | Passed | | Drying Time Test AAMI ST77:2013 ISO 17665-1:2006/R2013 | To verify that the device is properly dried following processing in pre-vacuum steam sterilization cycle of 132C for 4.0 minutes and dry time of 10 minutes. | The results demonstrate EZ-TRAX™ meets or exceeds the minimum acceptance criteria for dry time. The EZ-TRAX™ is considered properly dried following processing in the steam prevacuum sterilization cycle of 132C / 270F, Exposure Time 4.0 minutes and Dry Time 10.0 minutes minimum. | Passed | | Handle 100 lbs force test AAMI ST77:2013 | To verify that tray handles did not break or show evidence of distortion, cracking or other | None of the tray handles broke loose, showed evidence of permanent distortion, cracking or other evidence of failure when tested with force of 50 lbs. | Passed | | | failure following testing with force of 50 lbs. | | | | Sterilization Validation of the EZ-TRAXTM Zimmer G7 Acetabular & Taperloc Containment Device (unorganized) steam pre- vacuum 132C (270F) for 4 minutes. | To verify that a Sterility Assurance Level of 10-6 can be achieved after processing in pre-vacuum steam. | The testing verified that a Sterility Assurance Level of 10-6 can be achieved after processing EZ-TRAXTM G7 Acetabular System / Taperloc Complete Hip System Containment Device in a steam pre-vacuum cycle at 132C (270F) and 4.0 minutes. | Passed | | AAMI ST8:2013 TIR12:2010 ST77:2013/R2018 ST79:2017 ISO 14937:2009/R2013 ISO 17665-1:2006/R2013 | | | | {12}------------------------------------------------ #### IX. CONCLUSIONS The conclusions drawn from the nonclinical tests demonstrate that the EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is as safe, as effective and performs as well as or better than the legally marketed device EZ-TRAX™Persona Knee Containment Device (K211007).