ACTIV ANKLE DISTAL AND DIAPHYSEAL FIBULA INNOVATION MEANS MOTION

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1 ACTIV ANKLE DISTAL AND DIAPHYSEAL FIBULA POLYAXIAL LOCKING FIXATION DUALTEC SYSTEM II Precontoured implants Polyaxiality of 20 2 surgical approaches : lateral and posterolateral

2 ACTIV ANKLE The ACTIV ANKLE range of plates is intended for the fixation of fractures, osteotomies and pseudarthrosis of the distal and the diaphyseal fibula in adults. DISTAL FIBULA PLATES LATERAL APPROACH POSTEROLATERAL APPROACH STANDARD PLATE Fixation of osteoporotic bone and complex fractures with or without syndesmosis injuries. NARROW PLATE Fixation of simple fractures with or without syndesmosis injuries. POSTEROLATERAL PLATE Fixation of short oblique fractures (Type B, as defined by the AO and Weber Classifications). TECHNICAL FEATURES A COMPREHENSIVE FAMILY OF PLATES LATERAL STANDARD LATERAL NARROW POSTEROLATERAL DIAPHYSEAL PLATE For diaphyseal simple fractures Syndesmosis areas for non-locking Ø3.5 mm and Ø4.0 mm screws Syndesmosis areas for non-locking Ø3.5 mm and Ø4.0 mm screws Bendable sections DTS2 polyaxial holes for locking and non-locking Ø2.8 mm screws. Holes for locking and nonlocking Ø3.5 mm screws. Oblong slots for cortical Ø3.5 mm screws.

3 TECHNICAL FEATURES A PRECONTOURED IMPLANT OPTIMAL ANATOMICAL CONGRUENCE The design of this implant is the result of a proprietary state-of-the-art mapping technology to establish the maximum congruence between the plate and the bone. PLATE BENDING - The diaphyseal part of the fibula can vary from one patient to the other. It is possible to bend the diaphyseal part of long plates at each appropriate area using bending irons for an optimal fit to the bone anatomy. - Bending is only possible in the areas intended for this purpose. In this area where the skin is very thin, the anatomical design of the plate and the buried screw heads prevent soft tissue irritation. - Each bendable area should be bent only once and in one direction. - Bending should not be performed excessively. ANGULAR RANGE : +/- 10 POLYAXIAL LOCKING FIXATION ANGULAR RANGE : +/- 10 POLYAXIAL LOCKING FIXATION Newclip Technics plates combine both polyaxial and locking technologies to create a fixed-angle construct particulary useful for poor bone quality and/or multifragmentary fractures. Clip Nut +/ 10 angle (cone : 20 ) DUALTEC SYSTEM II MONOAXIAL LOCKING SYSTEM FEATURES R ESULTS The threaded sections under the screw head and inside the hole have strictly the same characteristic (1): - Cylindrical internal thread profile, - Cylindrical external thread profile, Screw head cap (2), Plate and screw made from the same material: titanium alloy Low profile construct limiting cold welding risks for improved removal properties: - A perfect coaptation of both profiles when locking (1), - The buried screw head is stopped thanks to the cap in the slot insuring the locking (2).

4 SURGICAL TECHNIQUE PLACEMENT OF THE LATERAL PLATE Check the positioning of the fast guide thanks to the DISTAL and PROXIMAL marks. Lock the fast guide onto the plate with the screwdriver (ANC082E). The plate can be temporarily held in position with K-wires (Ø1.4 L120 mm). Drill (ANC089C) using the guide gauge (ANC191). The screw length can be directly read on the guide gauge. Insert a cortical screw (CT3.5Lxx) into the oblong slot with the screwdriver (ANC083C). For optimal positioning, slide the plate using the oblong slot and tighten the cortical screw. a) b) For the epiphyseal fixation, use the guide gauge (ANC268C) for polyaxial fixation (a) or guide gauge (ANC046C) for monoaxial fixation (b) using the pre-angled fast guide. The screw length can be directly read on the guide gauge. For the monoaxial distal slot, drill (ANC088C) using the guide gauge (ANC268C). Insert a Ø2.8 mm locking screw (SDT2.8Lxx) through the fast guide using the screwdriver (ANC082E). Repeat the whole procedure to insert the remaining distal locking screws (SDT2.8Lxx). FINAL RESULT For the diaphyseal fixation, use the guide gauge (ANC186) and insert a Ø3.5 mm locking screw (SOT3.5Lxx) using the screwdriver (ANC083C). Repeat the procedure to insert the remaining locking screws. Then use the guide gauge (ANC191) and insert the remaining cortical screws (CT3.5Lxx) using the screwdriver (ANC083C). NB : in the case of a bicortical fixation, the drilling depth can be checked on the length gauge (ANC124). To make the insertion of the SOT3.5Lxx locking screws easier, widen the drilling made in the first cortex using the hand reamer (ANC463). Note : The fixation steps remain unchanged for Narrow (RTSLNx) or Posterolateral (RTxQ1) plates.

5 SURGICAL TECHNIQUE SYNDESMOTIC FIXATION FINAL RESULT Drill (ANC256M) through the holes designed for syndesmotic screws using the guide gauge (ANC261M). The screw length can be directly read on the guide gauge. Insert (ANC083C) a syndesmotic screw (CT3.5Lxx or QT4.0Lxx) into the appropriate oblong slot and/ or standard hole designed for that purpose. Note : The syndesmotic screw must be removed (using the ANC107 safety key) once the syndesmosis has healed, usually after six to eight weeks. OPTION: PRELIMINARY REDUCTION OF THE FRACTURE WITH A SCREW Example of preliminary reduction of the fracture using an obliquely angled screw: Reduce and temporarily maintain the fracture with bone reduction forceps, making sure not to hinder the subsequent positioning of the screw. Drill with the Ø2.7 mm drill bit (ANC089C) using the guide gauge (ANC191). The drilling should be perpendicular to the line of fracture. Note : The screw length can be directly read on the guide gauge. Always ensure that the guide gauge sits flush against the bone surface. When a lag effect is necessary, over-drill the anterior cortex only using the Ø3.5 mm drill bit (ANC542). Insert the cortical screw (CT3.5Lxx) through the line of fracture. In the case of osteoporotic bone, add a compression washer (WASH-T4) under the screw head so as to obtain optimal compression. FINAL RESULT Note : As an osteosynthesis screw used alone cannot bear weight and resist shear stresses, a plate should be used to allow early mobilization.

6 IMPLANTS REFERENCES DISTAL PLATES LATERAL STANDARD PLATES RTGLS1 RTDLS1 RTGLS2 RTDLS2 RTGLS3 RTDLS3 RTGLS4 RTDLS4 RTGLS5 RTDLS5 Lateral distal fibula plate - Standard - Left - Size 1 - L75 mm Lateral distal fibula plate - Standard - Right - Size 1 - L75 mm Lateral distal fibula plate - Standard - Left - Size 2 - L97 mm Lateral distal fibula plate - Standard - Right - Size 2 - L97 mm Lateral distal fibula plate - Standard - Left - Size 3 - L128 mm Lateral distal fibula plate - Standard - Right - Size 3 - L128 mm Lateral distal fibula plate - Standard - Left - Size 4 - L158 mm Lateral distal fibula plate - Standard - Right - Size 4 - L158 mm Lateral distal fibula plate - Standard - Left - Size 5 - L187 mm Lateral distal fibula plate - Standard - Right - Size 5 - L187 mm LATERAL NARROW PLATES RTSLN1 RTSLN2 Lateral distal fibula plate - Narrow - Size 1 - L76 mm Lateral distal fibula plate - Narrow - Size 2 - L102 mm POSTEROLATERAL PLATES RTGQ1 RTDQ1 Posterolateral distal fibula plate - Left - Size 1 - L73 mm Posterolateral distal fibula plate - Right - Size 1 - L73 mm DIAPHYSEAL PLATE DIAPHYSEAL PLATE FTS1 Diaphyseal fibula plate - Size 1 - L65 mm

7 IMPLANTS REFERENCES Ø2.8 MM SCREWS LOCKING SCREWS * NON-LOCKING SCREWS * SDT2.8L10 Ø2.8 mm locking screw - L10 mm QDT2.8L10 Ø2.8 mm non locking screw - L10 mm SDT2.8L12 Ø2.8 mm locking screw - L12 mm QDT2.8L12 Ø2.8 mm non locking screw - L12 mm SDT2.8L14 Ø2.8 mm locking screw - L14 mm QDT2.8L14 Ø2.8 mm non locking screw - L14 mm SDT2.8L16 Ø2.8 mm locking screw - L16 mm QDT2.8L16 Ø2.8 mm non locking screw - L16 mm SDT2.8L18 Ø2.8 mm locking screw - L18 mm QDT2.8L18 Ø2.8 mm non locking screw - L18 mm SDT2.8L20 Ø2.8 mm locking screw - L20 mm QDT2.8L20 Ø2.8 mm non locking screw - L20 mm SDT2.8L22 Ø2.8 mm locking screw - L22 mm QDT2.8L22 Ø2.8 mm non locking screw - L22 mm SDT2.8L24 Ø2.8 mm locking screw - L24 mm QDT2.8L24 Ø2.8 mm non locking screw - L24 mm * Green anodized. Ø3.5 MM SCREWS * Golden anodized. LOCKING SCREWS * NON-LOCKING SCREWS * CORTICAL SCREWS * SOT3.5L10 Ø3.5 mm locking screw - L10 mm QOT3.5L10 Ø3.5 mm non locking screw - L10 mm CT3.5L10 Ø3.5 mm cortical screw - L10 mm SOT3.5L12 Ø3.5 mm locking screw - L12 mm QOT3.5L12 Ø3.5 mm non locking screw - L12 mm CT3.5L12 Ø3.5 mm cortical screw - L12 mm SOT3.5L14 Ø3.5 mm locking screw - L14 mm QOT3.5L14 Ø3.5 mm non locking screw - L14 mm CT3.5L14 Ø3.5 mm cortical screw - L14 mm SOT3.5L16 Ø3.5 mm locking screw - L16 mm QOT3.5L16 Ø3.5 mm non locking screw - L16 mm CT3.5L16 Ø3.5 mm cortical screw - L16 mm SOT3.5L18 Ø3.5 mm locking screw - L18 mm QOT3.5L18 Ø3.5 mm non locking screw - L18 mm CT3.5L18 Ø3.5 mm cortical screw - L18 mm SOT3.5L20 Ø3.5 mm locking screw - L20 mm QOT3.5L20 Ø3.5 mm non locking screw - L20 mm CT3.5L20 Ø3.5 mm cortical screw - L20 mm SOT3.5L22 Ø3.5 mm locking screw - L22 mm QOT3.5L22 Ø3.5 mm non locking screw - L22 mm CT3.5L22 Ø3.5 mm cortical screw - L22 mm SOT3.5L24 Ø3.5 mm locking screw - L24 mm QOT3.5L24 Ø3.5 mm non locking screw - L24 mm CT3.5L24 Ø3.5 mm cortical screw - L24 mm * Blue anodized. * Pink anodized. * Non anodized. SYNDESMOTIC SCREWS Ø3.5 mm Ø4.0 mm CORTICAL SCREWS * LAG SCREWS * CT3.5L40 Ø3.5 mm cortical screw - L40 mm QT4.0L40 Ø4.0 mm lag screw - L40 mm CT3.5L45 CT3.5L50 Ø3.5 mm cortical screw - L45 mm Ø3.5 mm cortical screw - L50 mm QT4.0L45 QT4.0L50 Ø4.0 mm lag screw - L45 mm Ø4.0 mm lag screw - L50 mm Remark: CT3.5L55 CT3.5L60 CT3.5L65 Ø3.5 mm cortical screw - L55 mm Ø3.5 mm cortical screw - L60 mm Ø3.5 mm cortical screw - L65 mm QT4.0L55 QT4.0L60 QT4.0L65 Ø4.0 mm lag screw - L55 mm Ø4.0 mm lag screw - L60 mm Ø4.0 mm lag screw - L65 mm Please note that all implants are also available in sterile packaging.the Sosafe tube packaging is handy and easy to use. An ST code is added at the end of the reference. CT3.5L70 Ø3.5 mm cortical screw - L70 mm QT4.0L70 Ø4.0 mm lag screw - L70 mm Eg. : «SDT2.8L10-ST» * Non anodized. * Non anodized. COMPRESSION WASHER, OPTIONAL WASH-T4

8 INSTRUMENTS REFERENCES INSTRUMENTS Qty ANC046C Guide gauge Ø2.0 mm 1 ANC082E 2.0 mm quick coupling hexagonal prehensor screwdriver 1 ANC083C 2.5 mm quick coupling hexagonal prehensor screwdriver 2 ANC084 Ø2.7 mm quick coupling reamer 1 ANC088C Ø2.0 mm quick coupling drill bit - L125 mm 2 ANC089C Ø2.7 mm quick coupling drill bit - L125 mm 2 ANC102 Length gauge for Ø2.8 mm screws 1 ANC mm hexagonal non prehensor screwdriver 1 ANC mm quick coupling hexagonal non prehensor screwdriver 1 ANC124 Length gauge for Ø3.5 mm (cortical) screws 1 ANC186 Ø2.7 mm guide gauge for Ø3.5 mm locking screws 2 ANC191 Ø2.7 mm guide gauge for Ø3.5 mm non locking screws 1 ANC252 Fast drilling guide for RTGLSx plates 1 ANC253 Fast drilling guide for RTDLSx plates 1 ANC256M Quick coupling drill bit Ø2.7 mm - L180 mm 1 ANC261M Ø2.7 mm guide gauge for Ø mm non locking long screws 1 ANC268C Ø2.0 mm Guide gauge for locking screws 2 ANC349 Verbrugge forceps - 15 cm 2 INSTRUMENTS Qty ANC350 Ø4.5 mm AO quick coupling handle - Size 1 2 ANC452 Bending iron 2 ANC454 Fast drilling guide for RTGQx plates 1 ANC455 Fast drilling guide for RTDQx plates 1 ANC456 Fast drilling guide for RTSLNx plates 1 ANC463 Ø3.5 mm quick coupling reamer 1 ANC503 Reduction forceps 150 mm 1 ANC504 Reduction forceps 150 mm - pointed K-wires - Ø1.4 L120 mm 6 OPTIONAL INSTRUMENTS Qty ANC542 Quick coupling drill bit Ø3.5 mm - L125 mm 1 A10407M 12 cm pin for washers Prehensive plier for washer 1 REMOVAL SET If you have to remove Activ Ankle implants, make sure to order the Newclip Technics removal set which includes the following instruments : - ANC103 for Ø2.8 mm screws - ANC107 or ANC016 for Ø3.5 mm and Ø4.0 mm screws - ANC350 : Ø4.5 mm AO quick coupling handle - Size 1 SET DESCRIPTION IMPLANTS TRAY (ANC254/I1) ANCILLARIES TRAY (ANC254/I2) BASE (ANC254/B) SYNDESMOTIC TRAY (ANC254/I3) SCREWS RACK (ANC254/R) Brochure EN - Activ Ankle - Ed.3-03/ Medical device class IIb - CE 0120 SGS UK - Read labeling and instructions before use. Non contractual pictures. NEWCLIP TECHNICS PA de la Lande Saint Martin - 45 rue des Garottières Haute Goulaine (France) Phone : +33 (0) Fax : +33 (0) NEWCLIP USA 642 Larkfield Center Santa Rosa CA 95403, USA Phone :

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