WRIST SYSTEM. ARIX Volar Distal Radius Locking Plate System

Transcription

1 WRIST SYSTEM A

2 Contents Indications Product Overview Features & Benefits Ordering Information - Screws -2.5mm Self-Tapping Cortical Screws (Non-Locking) -2.5mm Self-Tapping Locking Screws Ordering Information - Plates -ARIX Volar Distal Radius Plates Ordering Information - Instruments Set Configuration Suggestion 2 ARIX WRIST SYSTEM

3 Indications is intended for use in temporary internal fixation and stabilization of fractures, osteotomies, and non-unions of the distal radius. 3

4 Product Overview Screw Specifications Screw Types Outer Diameter Length Insertion Types Screw Head Recess Color Material Locking Screw Cortical Screw (Non-Locking) Ø2.5mm 8 ~30mm Self-Tapping Hexagonal Silver Titanium Alloy Plate Specifications Distal Head Types Thickness Overall Length Head Width Color Material Guide Pin Hole Medium Large Extra Large 1.8mm 46mm and 73mm 19.6mm 23mm 27mm Blue Pure Titanium Gr.4 Ø1.3mm Color Coding Screws : Silver Plates : Blue Materials of Implants All plates are made from pure titanium material in conformity with ASTM F67. All screws are made from titanium alloy material in conformity with ASTM F136. The titanium is an ideal material for implant. It is biocompatible, corrosion resistant, and non-toxic in biological environment. 4 ARIX WRIST SYSTEM

5 Product Overview Screw Head Recess Self-retaining hexagonal recess for connection between screw head and screwdriver shaft Screw Options Cortical Screw (Non-Locking) Locking Screw Self-tapping Locking Screws : 8mm ~ 30mm Self-tapping Cortical Screws(Non-Locking) : 8mm ~ 30mm Outer Diameter : 2.5mm 5

6 Product Overview Plate Options 12 Volar Distal Radius Plates for Left and Right radiuses. 3 types of Distal Head as Medium, Large, and Extra Large 2 types of Shaft Length as 2 and 4 locking holes on the shaft Extra Large 6 ARIX WRIST SYSTEM Large Medium Extra Large Large Medium Large Extra Large Medium Large Extra Large

7 Lunate facet Radial styloid fragment Features and Benef its Anatomical Volar Plate Anatomical plate contour and screw trajectories for maximum support of lunate facet and stable fixation of radial styloid Minimal soft tissue irritation Minimal screw head prominence Rounded screw head Rounded plate edges to minimize soft tissue irritation Rounded screw head design and minimal screw head prominence in the plate to reduce the potential for soft tissue irritation. Low overall profile of the plate and screw construct for minimal soft tissue irritation. Rounded plate edges Low overall profile Anatomical 4 plane cutting for less soft tissue irritation 7

8 Features and Benef its Poly-Axial Locking System The poly-axial hole of a plate accepts locking or cortical screws as surgical needs. Locking screws as well as cortical screws can be inserted in ±15 with respect to the plate in any direction. Benefits of Locking Plating System ±15 Locking plate and screw system provides more stable fixation than conventional plate and screw system. Locking screws will not be loosened from the plate during the healing process. Locking screws do not rely on bone to plate compression. A fixed angle construct can be created by using locking screws in osteopenic bone or multifragmentary fractures where secure bone purchase with conventional screws may be compromised. 8 ARIX WRIST SYSTEM

9 Features and Benef its Oblong hole for accurate plate positioning The oblong hole in the plate shaft allows distal or proximal adjustment for accurate plate positioning on the bone. 1mm increment lines are marked beside oblong hole as a reference for plate positioning. Easy Plate Identification Distal head size information such as Medium / Large / Extra Large and Plate type information such as Left / Right Left or Right type are marked on plates for easy plate identification. Distal head size 9

10 Features and Benef its Guide Pin holes to approximate the trajectories of the distal screws with respect to radiocarpal joint Guide Pin holes for temporary plate fixation The Guide Pin holes of a plate accept up to 1.2mm Guide Pin. Guide Pin can be placed for temporary maintenance of bone reduction and provisional plate fixation. Guide Pin hole to approximate the trajectories of the ulna screws with respect to DRUJ Guide Pin holes for provisional fixation of plate. Intraoperative simplicity in choosing screws 2.5mm locking and cortical screws can be used in any holes of a plate for intraoperative simplicity 2.5mm 2.5mm 10 ARIX WRIST SYSTEM

11 Features and Benef its Drill Guide Block The drill guide blocks enable insertion of screws in the nominal trajectory of each locking hole. The scaled drill guide of variable angle drill guide is necessary for the use of these blocks. Total 6 models in Medium/Large/Extra Large, and Left/Right plates. The drill guide blocks are made from radiolucent material. Fixed angle screw trajectories by drill guide blocks (Left type) [ L, L, L ] Fixed angle screw trajectories by drill guide blocks (Right type) [ R, R, R ] Distal 15 Radial 10 Distal 15 Ulnar 2 Distal 15 Ulnar 2 Distal 15 Radial 10 Distal 30 Radial 20 Distal 30 Radial 20 Distal 15 Ulnar 10 Distal 15 Ulnar 10 Distal 30 Radial 20 Distal 30 Radial 20 Distal 40 Radial 0 Distal 35 Ulnar 5 Distal 35 Ulnar 5 Distal 40 Radial 0 Radial side Ulnar side Ulnar side Radial side 11

12 Features and Benef its 15 Variable Angle Drill Guide Helps to drill pilot holes within the poly-axial range of ± Scales are marked on the drill guide & bit for prompt depth measurement without the help of a depth gauge. The tip of the drill guide has locking mechanism to offer stable locking with the plate temporarily. To lock the drill guide with the plate, position(1) & turn(2) the drill guide slightly in clockwise as described picture. (1) (2) Fixed Angle Drill Sleeve Helps to drill a pilot hole in the nominal trajectory of each locking hole. Scales are marked on the drill guide & bit for prompt depth measurement without the help of a depth gauge. 12 ARIX WRIST SYSTEM

13 Features and Benef its Depth Gauge Determine the optimal screw length with the depth gauge. The triangular-prism shaped scale of depth gauge shows the exact length in any direction. * 3 scales for ease of reading Plate Bender If necessary, bend distal radius plate to suit the patients anatomical conditions using a pair of plate benders. With the plate benders, hold & bend the plate around the center window. NOTE : Do Not bend the plate more than 5. Further or Repetitive bending may break the plate. 13

14 Ordering Information - Screws 2.5mm Self-Tapping Cortical Screws (Non-Locking) [Unit: mm] No. Code Head Diameter (A) Outer Diameter (B) Length (L) 1 25-HF HF HF A 4 25-HF HF HF Ø3.7 Ø HF L 8 25-HF HF HF HF B HF ARIX WRIST SYSTEM

15 Ordering Information - Screws 2.5mm Self-Tapping Locking Screws [Unit: mm] No. Code Head Diameter (A) Outer Diameter (B) Length (L) A Ø3.8 Ø L B 15

16 Ordering Information Plates ARIX Volar Distal Radius Plates 25-DVRA-109-L Volar Distal Radius Locking Plate, Left, Medium, Head Width 19.6mm, Length 46mm, 9 Locking Holes, Thickness 1.8mm, Blue 25-DVRA-109-R Volar Distal Radius Locking Plate, Right, Medium, Head Width 19.6mm, Length 46mm, 9 Locking Holes, Thickness 1.8mm, Blue 25-DVRA-111-L Volar Distal Radius Locking Plate, Left, Medium, Head Width 19.6mm, Length 73mm, 11 Locking Holes, Thickness 1.8mm, Blue 25-DVRA-111-R Volar Distal Radius Locking Plate, Right, Medium, Head Width 19.6mm, Length 73mm, 11 Locking Holes, Thickness 1.8mm, Blue 16 ARIX WRIST SYSTEM

17 Ordering Information Plates 25-DVRA-209-L Volar Distal Radius Locking Plate, Left, Large, Head Width 23mm, Length 46mm, 9 Locking Holes, Thickness 1.8mm, Blue 25-DVRA-209-R Volar Distal Radius Locking Plate, Right, Large, Head Width 23mm, Length 46mm, 9 Locking Holes, Thickness 1.8mm, Blue 25-DVRA-211-L Volar Distal Radius Locking Plate, Left, Large, Head Width 23mm, Length 73mm, 11 Locking Holes, Thickness 1.8mm, Blue 25-DVRA-211-R Volar Distal Radius Locking Plate, Right, Large, Head Width 23mm, Length 73mm, 11 Locking Holes, Thickness 1.8mm, Blue 17

18 Ordering Information Plates 25-DVRA-309-L Volar Distal Radius Locking Plate, Left, Extra Large, Head Width 27mm, Length 46mm, 9 Locking Holes, Thickness 1.8mm, Blue 25-DVRA-309-R Volar Distal Radius Locking Plate, Right, Extra Large, Head Width 27mm, Length 46mm, 9 Locking Holes, Thickness 1.8mm, Blue 25-DVRA-311-L Volar Distal Radius Locking Plate, Left, Extra Large, Head Width 27mm, Length 73mm, 11 Locking Holes, Thickness 1.8mm, Blue 25-DVRA-311-R Volar Distal Radius Locking Plate, Right, Extra Large, Head Width 27mm, Length 73mm, 11 Locking Holes, Thickness 1.8mm, Blue 18 ARIX WRIST SYSTEM

19 Ordering Information Instruments L Drill Guide Block, Medium, Left R Drill Guide Block, Medium, Right L Drill Guide Block, Large, Left R Drill Guide Block, Large, Right L Drill Guide Block, Extra Large, Left R Drill Guide Block, Extra Large, Right Fixed Angle Drill Sleeve for Ø2.0mm drill bit 113-HF-607 Hexagonal Screwdriver Shaft Guide Pin Ø1.1mm for Ø1.3 guide pin hole Drill Bit for 2.5mm screws, Ø2.0mm, Drilling length : 30mm, Overall length : 110mm, J-Latch Dispenser for guide pins 19

20 Ordering Information Instruments Plate Bender ARIX Volar Distal Radius Implant/Instrument Container Grasping Forceps Variable Angle Drill Guide for Ø2.0mm drill bit Screwdriver Handle Depth Gauge for 2.5mm screws 20 ARIX WRIST SYSTEM

21 Set Conf iguration Suggestion ARIX WRIST Ø2.5 Distal Radius Plate NO Code Description Set Quantity Implants _ Screws Locking Screw (8mm) Locking Screw (10mm) Locking Screw (12mm) Locking Screw (14mm) Locking Screw (16mm) Locking Screw (18mm) Locking Screw (20mm) Locking Screw (22mm) Locking Screw (24mm) Locking Screw (26mm) Locking Screw (28mm) Locking Screw (30mm) HF Cortical Screw (8mm) HF Cortical Screw (10mm) HF Cortical Screw (12mm) HF Cortical Screw (14mm) HF Cortical Screw (16mm) HF Cortical Screw (18mm) HF Cortical Screw (20mm) HF Cortical Screw (22mm) HF Cortical Screw (24mm) HF Cortical Screw (26mm) HF Cortical Screw (28mm) HF Cortical Screw (30mm) 5 NO Code Description Set Quantity Implants _ Plates DVRA-109-R Medium, Length 46mm, Right DVRA-109-L Medium, Length 46mm, Left DVRA-111-R Medium, Length 73mm, Right DVRA-111-L Medium, Length 73mm, Left DVRA-209-R Large, Length 46mm, Right DVRA-209-L Large, Length 46mm, Left DVRA-211-R Large, Length 73mm, Right DVRA-211-L Large, Length 73mm, Left DVRA-309-R Extra Large, Length 46mm, Right DVRA-309-L Extra Large, Length 46mm, Left DVRA-311-R Extra Large, Length 73mm, Right DVRA-311-L Extra Large, Length 73mm, Left 3 NO Code Description Set Quantity Instruments Screwdriver Handle Depth Gauge Drill bit for 2.5mm screws Variable Angle Drill Sleeve for Ø2.0mm drill bit Fixed Angle Drill Sleeve for Ø2.0 drill bit Grasping Forceps HF-607 Hexagonal Screwdriver Shaft R Drill Guide Block, Standard, Right L Drill Guide Block, Standard, Left R Drill Guide Block, Large, Right L Drill Guide Block, Large, Left R Drill Guide Block, Extra Large, Right L Drill Guide Block, Extra Large, Left Bender Guide Pin Dispenser for guide pins 1 21

22 2.5 Distal Radius Plates and Screws 22 ARIX WRIST SYSTEM

23 The Instruments are subject to change without prior notice to improve. Instruments for 2.5 Distal Radius Plates and Screws 23

24 Publication_1601 JEIL MEDICAL CORPORATION ho, 55, Digital-ro 34-gil, Guro-gu, Seoul, 08378, Rep. of Korea INTERNATIONAL SALES_ T F E global@jeilmed.co.kr DOMESTIC SALES_ T F E jeil@jeilmed.co.kr LBEN-M1601(03)