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The Tecomet Global Unite Short Stem Instrumentation (GUSS) are intended to be used to implant the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder, in accordance with its cleared indications for use and contraindications.

The Tecomet Global Unite Short Stem Instrumentation (GUSS) is intended only for use as surgical instrumentation for the DePuy GLOBAL UNITE Shoulder System Short Stem Shoulder. Tecomet manufactures this instrumentation exclusively for DePuy. The instrumentation is intended to be used with the GLOBAL UNITE Short Stem Shoulder System which was cleared separately under premarket notification K202098 (K202098 did not include instruments). The Tecomet GUSS instruments are a combination of Class I General Use Instruments, Class II Short Stem Shoulder-specific instruments and a Class II Sterilization Tray. The instruments include Humeral Stem Brosteotomes in 8mm-16mm sizes, a Stem Wrench, 155° Proximal Reaming Guides, 145° Proximal Reaming Guides, Bullet Tip Reamers and a sterilization tray. Although the tray is included in the system, it is not the subject of this premarket notification. The tray is already cleared by the Tecomet (Symmetry Medical) 510(k) K012105 (Polyvac Surgical Instrument Delivery System). The Tecomet Global Unite Short Stem Instrumentation (GUSS) is all manufactured from 17-4 PH SST Stainless Steel. The instruments are exclusively for, and must be used in accordance with the DePuy GLOBAL UNITE Platform Anatomic and Reverse Shoulder Surgical Technique. The devices are reusable and must be sterilized by the user prior to use.

FlashPak® is a reusable rigid container system to be used during immediate use steam sterilization (IUSS or flash) by hospitals and healthcare facilities. It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement steam sterilization using a 10 minute cycle at 132° C for porous items with lumens or a 3 minute cycle at 132° C for nonporous items like routine metal instruments. The container is also compatible with pre-vacuum steam sterilization using a 4 minute cycle at 132° C for porous items with lumens or a 3 minute cycle for nonporous items like routine metal instruments. FlashPak is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length). FlashPak® Model/Maximum Instrument Load Weight Recommendation: 9020 w/ 9020-08 Basket - Gravity 3 pounds (1.36 Kg) - Pre-Vacuum 3 pounds (1.36 Kg) 9030 w/ 9030-08 Basket - Gravity 10 pounds (4.55 Kg) - Pre-Vacuum 10 pounds (4.55 Kg) 9040 w/ 9040-08 Basket - Gravity 14 pounds (6.35 Kg) - Pre-Vacuum 14 pounds (6.35 Kg) 9050 w/ 9050-08 Basket - Gravity 16 pounds (7.27 Kg) - Pre-Vacuum 16 pounds (7.27 Kg)

The FlashPak Container System consists of a Radel® lid and base that together fully enclose a removable metal wire basket that holds items to be sterilized. A silicone gasket creates an air tight seal between the lid and base by means of metal latches. Two pressure actuated valves; one in the center of the lid and one in the center of the base, allow ingress and egress of steam sterilant into the container during the sterilization cycle and when closed form an airtight enclosure against separate silicone seals. The container comes in four sizes and is indicated for use with gravity-displacement and dynamic-air-removal sterilization modes recommended in ANSI/AAMI ST79 for immediate use steam sterilization (IUSS). Approved chemical indicators are recommended for use during each sterilization cycle.

The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a catheter accessory device intended for the minimally invasive removal of tunneled long term catheters. The Cuffed Catheter Removal Device is indicated for use with tunneled, double lumen Permcath catheters with sizes ranging from 6.0 French to 16.0 French

Symmetry Surgical Single Use Cuffed Catheter Removal devices are sold as sterile, single use devices, unless otherwise noted. The Symmetry Surgical Single Use Cuffed Catheter Removal Device is a tool for minimizing surgical trauma associated with catheter removal. The device jaws are normally in the closed position. The device is equipped with a trigger, a button located on the handle, actuated feature that opens the jaws. Upon release of the trigger, the jaws return to the normally closed position with a spring assist mechanism. The Single Use Cuffed Catheter Removal Device has no locking mechanism. During use the jaws are opened outside the patient and allowed to close around the catheter. The catheter then serves as a guide for moving the closed tip down into the catheter tunnel. When cutting the catheter cuff, the jaws may be activated to allow for tissue dissection and release which will then ease the catheter removal. The opening of the jaws in vivo are limited by the constraint of the surrounding tissue tunnel as well as the design limit of no more than a maximum angle of 57°.

FlashPak® is a reusable rigid container system to be used during flash sterilization by hospitals and healthcare facilities. It is intended to enable flash sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravitydisplacement flash sterilization using a 10 minute cycle at 132° C and with pre-vacuum flash sterilization using a 4 minute cycle at 132° C. FlashPak is recommended for surface sterilization of stainless steel instruments and for lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).

The FlashPak Container System consists of a family of rigid reusable containers that provide an effective sterilization packaging method for surgical instruments requiring flash steam sterilization. Each FlashPak system is comprised of an upper lid that seals by means of a silicone gasket and latches to a lower base creating a totally enclosed environment. A stainless steel wire basket is utilized inside the container to facilitate handling of sterilized items. The lid and base incorporate pressure actuated valves that open to allow sterilant to enter the container during the pressurization portion of the sterilization cycle and then close to seal the container once the cycle is over so the container and its contents can be removed from the sterilizer and immediately transported to the point of use without the risk of recontamination.

PolyVac's delivery systems consist of perforated trays with llds, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing sterilant penetration and air removal, When used In conjunction with an approved sterilization wrap.

PolyVac Delivery Systems consist of different sizes of the same basic configuration. All systems consist of a minimum of a plastic or metal base and lid. All lids can be fastened to the base by means of assembled hardware or by a locking tab, designed as part of the lid. Accessories may be used with systems to organize or separate contents to be placed in them for use. The Delivery Systems are designed using plastic and metal materials that can be reused with steam or Ethylene Oxide sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.

PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used. PolyVac's delivery systems are to be sterilized in one of the following cycles: Prevacuum Steam : 132°C - 4 minutes minimum; Gravity Steam: 132°C - 30 minutes minimum; Gravity Steam: 121°C - 55 minutes minimum

PolyVac Delivery Systems consist of different sizes of the same basic configuration. All systems consist of a minimum of a plastic or metal base and lid. All lids can be fastened to the base by means of assembled hardware or by a locking tab, designed as part of the lid. Accessories may be used with systems to organize or separate contents to be placed in them for use. The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and lid has an evenly distributed hole pattern in relation to its size.