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The Tricera™ Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Tricera™ Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera™ Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

The device description and principles of operation for the modified devices are equivalent to the device description of the predicate devices cleared per Primary Predicate-K233493 and additional predicate-K162770. A brief device description of the subject devices is provided in the table below. | Device | Description | |----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Curved Standard Ball<br>Burr XL, 5.0mm | An arthroscopic burr that provides abrasion, resection, debridement, and removal of bone. The Curved Dynablator XL is specifically designed for use in hip joints with a spherical ball burr and bent outer tube for access to hip pathology. | | Curved Standard<br>Shaver XL, 4.2mm | An arthroscopic shaver that provides resection and removal of soft tissue. The Curved Dynablator XL is specifically designed for use in hip joints with a bent outer tube for access to hip pathology. | | Curved Dynablator XL | An arthroscopic RF probe that provides removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels. The Curved Dynablator XL is specifically designed for use in hip joints with a bent outer tube for access to hip pathology. |

The Relign Tricera Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Tricera Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Relign Tricera Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

The device description for the modified device is identical to the device description of the predicate device cleared per K162770 with the exception of the sterilization methods for Relign's Shaver Handpiece, a component device of the Tricera Arthroscopic System, which is being changed as follows: Current Methods: STERRAD 100S, STERRAD 100NX, STERRAD NX. Proposed Methods: Steris V-PRO Lumen, Steam Autoclave. New Available Methods: STERRAD 100S, STERRAD 100NX, STERRAD NX, Steris V-PRO Lumen, Steam Autoclave.

The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Arthroscopic System provides fluid distension of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Relign Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

The Relign Arthroscopic System is a combination radiofrequency controller, shaver system, and fluid management system. The integrated system simultaneously controls a reusable shaver handpiece with disposable shaver blades and probes that include electrosurgical energy, as well as fluid management through inflow and outflow pumps that operate on the peristaltic principle. The system is comprised of five (5) major system components: The Relign Controller that includes a Footswitch, a reusable Shaver Handpiece, a disposable sterile single-use Combination Shaver Blade, a disposable sterile single-use Reciprocating RF Probe, and a disposable sterile single-use Fluid Management Accessories.