Synthes Graphic Case & Tray System

K241927 · Synthes GmbH · KCT · Mar 28, 2025 · General Hospital

Device Facts

• Record ID: K241927
• Device Name: Synthes Graphic Case & Tray System
• Applicant: Synthes GmbH
• Product Code: KCT · General Hospital
• Decision Date: Mar 28, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterlity; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers). The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C. The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap). Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes

Device Story

Modular, reusable case and tray system; stores, organizes, and transports orthopedic instruments and implants during steam sterilization and surgical procedures. Components (cases, trays, lids) are perforated for steam penetration; constructed from aluminum, stainless steel, and silicone. Used in healthcare facilities; operated by clinical staff. System requires external FDA-cleared sterile barrier (wrap or rigid container) to maintain sterility. Validated for 25 lbs maximum load; steam sterilization (pre-vacuum, 270°F, 4-minute exposure, 20-minute dry time). Protects instruments during transport; ensures effective sterilization of complex device configurations (lumens, mated surfaces).

Clinical Evidence

Bench testing only. No clinical data. Testing included sterilization efficacy (SAL 10^-6), dry time/thermal profiling, manual and automated cleaning validation (protein/hemoglobin analytes), biocompatibility (ISO 10993-5), and durability (104 reprocessing cycles).

Technological Characteristics

Materials: Aluminum (lid/base), silicone/aluminum/stainless steel (inserts), stainless steel (latches). Design: Modular perforated cases/trays/lids. Energy: Steam (moist heat). Connectivity: None. Sterilization: Pre-vacuum steam (270°F). Dimensions: Range 7.1-20.1" L x 9.7" W x 1.9-6.6" H.

Indications for Use

Indicated for healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. Validated for orthopedic devices including lumen (cannulated) and mated surface devices. Compatible with stable metals, composites, thermoplastics, and thermosetting polymers (>135°C). Not intended to maintain sterility independently; requires FDA-cleared sterile barrier.

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

• CrossRoads Tray System (K202268)

Reference Devices

• DePuy Synthes Sterilization Container System (K181933)

Submission Summary (Full Text)

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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 seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.

March 28, 2025

Synthes GmbH Thomas Shea Manger, Regulatory Affiars Luzernstrasse 21 Zuchwil, SO 4528 Switzerland

Re: K241927

Trade/Device Name: Synthes Graphic Case & Tray System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 26, 2025 Received: February 26, 2025

Dear Thomas Shea:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Digitally signed by Stephen A. Digitally signed by
Stephen A. Anisko -S Anisko -S Date: 2025.03.28 16:08:45 -04'00'

for: Christopher Dugard Director DHT4C: Division of Infection Control 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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# Indications for Use

510(k) Number (if known) K241927

Device Name Synthes Graphic Case & Tray System

#### Indications for Use (Describe)

The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterlity; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).

The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.

The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap).

Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes

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

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| Synthes Graphic Case & Tray System - Description and Dimensions | | | | |
|-----------------------------------------------------------------|-----------------------------------|-------------------------------------------------|------------------|----------------------------------------------------------|
| Part Number | Part Description | Volume to Vent<br>Ratio (in³/in²)<br>(with Lid) | Weight<br>(lbs.) | Dimensions (in)<br>(L x W x H) Case/Tray<br>(L x W) Lids |
| Outer Cases | | | | |
| 60.133.181 | 1 High, 1/3 width outer case | 5.62 | 1.62 | 7.1 x 9.7 x 1.9 |
| 60.133.182 | 1 High, 2/3 width outer case | 4.84 | 2.19 | 13.6 x 9.7 x 1.9 |
| 60.133.183 | 1 High, 3/3 width outer case | 4.72 | 2.73 | 20 x 9.7 x 1.9 |
| 60.133.213 | 2 High, 1/3 width outer case | 8.11 | 2.10 | 7.1 x 9.7 x 3.4 |
| 60.133.223 | 2 High, 2/3 width outer case | 7.35 | 2.78 | 13.6 x 9.7 x 3.4 |
| 60.133.200 | 2 High, 3/3 width outer case | 6.12 | 3.41 | 20 x 9.7 x 3.4 |
| 60.133.313 | 3 High, 1/3 width outer case | 9.34 | 2.51 | 7.1 x 9.7 x 5 |
| 60.133.323 | 3 High, 2/3 width outer case | 8.81 | 3.31 | 13.6 x 9.7 x 5 |
| 60.133.300 | 3 High, 3/3 width outer case | 8.30 | 4.04 | 20 x 9.7 x 5 |
| 60.133.413 | 4 High, 1/3 width outer case | 10.05 | 2.92 | 7.1 x 9.7 x 6.6 |
| 60.133.423 | 4 High, 2/3 width outer case | 9.69 | 3.83 | 13.6 x 9.7 x 6.6 |
| 60.133.400 | 4 High, 3/3 width outer case | 9.19 | 4.65 | 20 x 9.7 x 6.6 |
| Case Lids | | | | |
| Synthes Graphic Case & Tray System - Description and Dimensions | | | | |
| Part Number | Part Description | Volume to Vent<br>Ratio (in³/in²)<br>(with Lid) | Weight<br>(lbs.) | Dimensions (in)<br>(L x W x H) Case/Tray<br>(L x W) Lids |
| 60.133.013 | 1/3 width lid | n/a | .60 | 7.1 x 9.7 |
| 60.133.023 | 2/3 width lid | n/a | 1.01 | 13.6 x 9.7 |
| 60.133.000 | 3/3 width lid | n/a | 1.59 | 20 x 9.7 |
| Auxiliary Trays * Representative for all 1 high Tray size | | | | |
| 60.133.103 | Auxiliary Tray 1/3 width | 5.62 | 0.89 | 6.34 x 9.25 x 1.77 |
| 60.133.169 | Auxiliary Tray, 1 High, 2/3 Width | 4.84 | 1.80 | 12.80 x 9.25 x 1.77 |
| 60.133.171 | Auxiliary Tray, 1 High, 3/3 Width | 4.72 | 2.70 | 19.25 x 9.25 x 1.77 |
| Auxiliary Tray Lids | | | | |
| 60.133.111 | Lid (1/3 Width), Aluminium Tray | n/a | 0.81 | 6.61 x 9.65 |
| 60.133.110 | Lid (2/3 Width), Aluminium Tray | n/a | 1.33 | 13.07 x 9.65 |
| 60.133.109 | Lid 3/3 Aluminium Tray | n/a | 1.79 | 19.53 x 9.65 |

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# 510(k) Summary K241927

| Sponsor | Synthes GmbH<br>Luzernstrasse 21<br>4528 Zuchwil, Switzerland |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Thomas Shea<br>Manager, Regulatory Affairs<br>T: [phone]<br>E: [e-mail] |
| Alternate Contact | Damon Lees<br>Director, Regulatory Affairs<br>T: [phone]<br>E: [e-mail] |
| Date Prepared | March 25, 2025 |
| Proprietary Name | Synthes Graphic Case & Tray System |
| Classification<br>Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Classification | Class II<br>Regulation Number: 21 CFR 880.6850<br>Product Code: KCT |
| Predicate /<br>Reference<br>devices | Predicate Device: CrossRoads Tray System (K202268)<br>Reference Device: DePuy Synthes Sterilization Container System (K181933) |
| Device<br>Description | The Synthes Graphic Case and Tray System is a modular, reusable case and tray<br>system intended for use in health care facilities for the purpose of containing<br>medical devices for sterilization. It is composed of multiple pieces, designed to be<br>integrated into a single unit that contains and protects instruments and implants<br>during sterilization and transport. All components are perforated for steam<br>penetration. |
| Indications for<br>Use | The Synthes Graphic Case & Tray System are used in healthcare facilities to<br>store, organize, and transport DePuy Synthes orthopedic instruments and<br>implants during sterilization and surgical procedures. The Synthes Graphic Case<br>& Tray System are not intended on their own to maintain sterility; they are intended<br>to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g.,<br>wraps or reusable rigid sterilization containers).<br>The Synthes Graphic Case & Tray System is validated for use with orthopedic<br>medical devices including lumen (cannulated) devices and mated surface devices<br>(devices or device configurations with conjoined surfaces which meet, touch or<br>unite). Compatible instrument and implant materials include intrinsically stable<br>metals, composites, thermoplastics and thermosetting polymers with constant use<br>temperatures above 135°C. |
| | The Synthes Graphic Case & Tray System were validated for a maximum load of<br>25 lbs (case + contents+ lid+ weight of sterile barrier wrap). |
| | Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum<br>Temperature: 270 °F (132 °C)<br>Exposure time: 4 minutes<br>Minimum Drying time: 20 minutes |

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| Part Number | Part Description | Volume to Vent Ratio (in³/in²) (with Lid) | Weight (lbs.) | Dimensions (in) (L x W x H) Case/Tray (L x W) Lids |
|-----------------------------------------------------------|-----------------------------------|-------------------------------------------|---------------|----------------------------------------------------|
| Outer Cases | | | | |
| 60.133.181 | 1 High, 1/3 width outer case | 5.62 | 1.62 | 7.1 x 9.7 x 1.9 |
| 60.133.182 | 1 High, 2/3 width outer case | 4.84 | 2.19 | 13.6 x 9.7 x 1.9 |
| 60.133.183 | 1 High, 3/3 width outer case | 4.72 | 2.73 | 20 x 9.7 x 1.9 |
| 60.133.213 | 2 High, 1/3 width outer case | 8.11 | 2.10 | 7.1 x 9.7 x 3.4 |
| 60.133.223 | 2 High, 2/3 width outer case | 7.35 | 2.78 | 13.6 x 9.7 x 3.4 |
| 60.133.200 | 2 High, 3/3 width outer case | 6.12 | 3.41 | 20 x 9.7 x 3.4 |
| 60.133.313 | 3 High, 1/3 width outer case | 9.34 | 2.51 | 7.1 x 9.7 x 5 |
| 60.133.323 | 3 High, 2/3 width outer case | 8.81 | 3.31 | 13.6 x 9.7 x 5 |
| 60.133.300 | 3 High, 3/3 width outer case | 8.30 | 4.04 | 20 x 9.7 x 5 |
| 60.133.413 | 4 High, 1/3 width outer case | 10.05 | 2.92 | 7.1 x 9.7 x 6.6 |
| 60.133.423 | 4 High, 2/3 width outer case | 9.69 | 3.83 | 13.6 x 9.7 x 6.6 |
| 60.133.400 | 4 High, 3/3 width outer case | 9.19 | 4.65 | 20 x 9.7 x 6.6 |
| Case Lids | | | | |
| Part Number | Part Description | Volume to Vent Ratio (in³/in²) (with Lid) | Weight (lbs.) | Dimensions (in) (L x W x H) Case/Tray (L x W) Lids |
| 60.133.013 | 1/3 width lid | n/a | .60 | 7.1 x 9.7 |
| 60.133.023 | 2/3 width lid | n/a | 1.01 | 13.6 x 9.7 |
| 60.133.000 | 3/3 width lid | n/a | 1.59 | 20 x 9.7 |
| Auxiliary Trays * Representative for all 1 high Tray size | | | | |
| 60.133.103 | Auxiliary Tray 1/3 width | 5.62 | .89 | 6.34 x 9.25 x 1.77 |
| 60.133.169 | Auxiliary Tray, 1 High, 2/3 Width | 4.84 | 1.80 | 12.80 x 9.25 x 1.77 |
| 60.133.171 | Auxiliary Tray, 1 High, 3/3 Width | 4.72 | 2.70 | 19.25 x 9.25 x 1.77 |
| Auxiliary Tray Lids | | | | |
| 60.133.111 | Lid (1/3 Width), Aluminium Tray | n/a | 0.81 | 6.61 x 9.65 |
| 60.133.110 | Lid (2/3 Width), Aluminium Tray | n/a | 1.33 | 13.07 x 9.65 |
| 60.133.109 | Lid 3/3 Aluminium Tray | n/a | 1.79 | 19.53 x 9.65' |

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## Technological Comparison

Presented below is a Technological Comparison covering the design and performance specifications of the subject device and the predicate.

| Comparator | Subject Device (K241927) | Predicate Device (K202268) | Comparison |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Synthes Graphic Case and Tray<br>System | CrossRoads Tray System | |
| Device Image | Image: Synthes Graphic Case and Tray System | Image: CrossRoads Tray System | |
| Product Code | KCT | KCT | Same |
| Intended Use | The Synthes Graphic Case and<br>Tray System is designed to<br>hold surgical implants and<br>instruments in order to<br>organize, steam sterilize and<br>transport the devices between<br>uses. The cases and trays are<br>intended to be wrapped with an<br>FDA-cleared sterilization wrap<br>or placed within a reusable<br>sterilization container during the<br>pre-vacuum autoclave<br>sterilization process. | The CrossRoads Tray System<br>is designed to hold various<br>surgical instruments in order to<br>organize, steam sterilize and<br>transport the instruments<br>between uses. The trays are<br>wrapped with an FDA-cleared<br>sterilization wrap during the<br>pre-vacuum autoclave<br>sterilization process. | Similar |
| Comparator | Subject Device (K241927) | Predicate Device (K202268) | Comparison |
| Indications for<br>Use | The Synthes Graphic Case &<br>Tray System is used in<br>healthcare facilities to store,<br>organize, and transport DePuy<br>Synthes orthopedic instruments<br>and implants during sterilization<br>and surgical procedures. The<br>Synthes Graphic Case & Tray<br>System are not intended on<br>their own to maintain sterility;<br>they are intended to be used in<br>conjunction with a legally<br>marketed, FDA-cleared sterile<br>barrier (e.g., wraps or reusable<br>rigid sterilization containers).<br>The Synthes Graphic Case &<br>Tray System is validated for<br>use with orthopedic medical<br>devices including lumen<br>(cannulated) devices and<br>mated surface devices (devices<br>or device configurations with<br>conjoined surfaces which meet,<br>touch or unite). Compatible<br>instrument and implant<br>materials include intrinsically<br>stable metals, composites,<br>thermoplastics and<br>thermosetting polymers with<br>constant use temperatures<br>above 135°C.<br>The Synthes Graphic Case &<br>Tray System were validated for | The CrossRoads Tray System<br>is used in healthcare facilities to<br>store and organize CrossRoads<br>surgical instruments and<br>components during<br>cleaning/sterilization and during<br>implant/prosthetic treatment.<br>The CrossRoads Tray System<br>are not intended on their own to<br>maintain sterility; it is intended<br>to be used in conjunction with a<br>legally marketed, validated,<br>FDA-cleared sterilization pouch<br>or sterilization wrap.<br>Sterilization validations for the<br>worst-case CrossRoads Tray<br>System included surgical<br>instruments such as drills,<br>inserters, reamers, fixation pin,<br>benders, and ratcheting<br>handles. The CrossRoads Tray<br>System is validated for a<br>maximum load of 8.5 lbs (tray +<br>instruments).<br>Method: Steam Sterilization<br>(Moist Heat Sterilization) Cycle<br>Pre-vacuum<br>Temperature: 270 °F (132 °C)<br>Exposure time: 4 minutes<br>Drying time: 20 minutes<br>The tray is 20.60" length x 9.80"<br>width x 2.00" depth. | Different,<br>subject<br>device<br>includes<br>indications<br>for device<br>types and<br>materials<br>validated for<br>use with the<br>system. |
| | a maximum load of 25 lbs (case<br>+ contents+ lid+ weight of<br>sterile barrier wrap).<br>Method: Steam Sterilization<br>(Moist Heat Sterilization) Cycle<br>Pre-vacuum<br>Temperature: 270 °F (132 °C)<br>Exposure time: 4 minutes<br>Minimum Drying time: 20 | | |
| Intended<br>Device Load | minutes<br>Implants and instruments | Implants and instruments | Same |
| Max Weight | 25 lbs (case + contents+ lid +<br>weight of sterile barrier) | 8.5 lbs (tray + instruments) | Different,<br>subject<br>system is<br>validated for<br>a greater<br>max load |
| Materials | Lid/base— Aluminum<br>Inserts - Silicone, Aluminum,<br>Stainless Steel<br>Latch - Stainless Steel | Lid/base/Lift out tray -<br>Aluminum Inserts - Silicone,<br>aluminum, stainless steel<br>Latch - Stainless steel | Similar |
| Design | Outer case, inner tray, lids | Base and lid | Similar |
| Comparator | Subject Device (K241927) | Predicate Device (K202268) | Comparison |
| Dimensions | Cases and trays ranging in size<br>from 7.2 – 20.1 length x 9.8<br>width x 1.8 – 6.5 inches depth<br>See Table in IFU for complete<br>list of cases and trays with<br>dimensions. | 20.60 length x 9.80 width x<br>2.00 inches depth | Different,<br>subject<br>system offers<br>a range of<br>sizes |
| Sterilization Parameters | | | |
| Sterilization<br>Method | Pre-vacuum (steam) | Pre-vacuum (steam) | Same |
| Cycle<br>Temperature | 270°F (132°C) | 270°F (132°C) | Same |
| Cycle Time | 4 minutes | 4 minutes | Same |
| Dry Time | 20 minutes | 20 minutes | Same |
| Sterile Barrier | FDA cleared sterilization wrap or<br>rigid container…