Search Results
Found 1 results
510(k) Data Aggregation
K Number
K241008Device Name
Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece, Autoclavable (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr 5.0mm (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024); Curved Standard Ball Burr XL, 5.0mm (R-10025); Curved Shaver XL 4.2mm (R-10026); Curved Dynablator, XL (R-10027)
Manufacturer
Relign Corporation, Subsidiary of Zimmer Biomet
Date Cleared
2024-05-08
(26 days)
Product Code
GEI, HRX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Relign Corporation, Subsidiary of Zimmer Biomet
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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. |
Ask a Question
Page 1 of 1