Implants trauma Foot Locking Plates System

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a board certified physician. WARNING: If there is no sufficient bone healing, wrong or incomplete postoperative care, plate might break. All ITS plates are preformed anatomically as a matter of principle. If adjustment of the plate to the shape of the bone is required, this is possible by carefully bending gently in one direction once. Particular care is required when bending in the region of a plate hole, as deformation of the plate may lead to a failure of the locking mechanism. The plate must not be buckled or bent...

1. Introduction P. 5 Preface P. 6 Screws P. 7 Properties P. 8 Indications & Contraindications 2. Surgical Technique P. 10 FLS Plate L-Shape P. 10 Temporary fixation with K-Wires P. 11 Placement of the screws P. 13 Postoperative treatment P. 13 Explantation 3. Information P. 15 Locking P. 15 Dotize® P. 16 Order list P. 19 Notes P. 20 Reconditioning Manual

Preface The FLS - Foot Locking System from I.T.S. is a proven osteosynthesis system with various plate types covering a wide range of indications for fractures of the foot. The special feature of these implants is the free choice of screw placement. The user is able to set any desired screw in any hole either locking or non-locking screw (except in the compression hole). The free choice of screw angulation (+/- 15°, see page 15) provides an advantage in fracture treatment, especially in the case of complex fractures.

Screws - Foot Locking Plates System 32271-XX Spiral Drill, D=2.0mm, L=100mm, AO Connector Cortical Stabilization Screw, D=3.0mm, RH Spiral Drill, D=2.4mm, L=100mm, AO Connector Cancellous Stabilization Screw, D=3.0mm, RH Spiral Drill, D=2.0mm, L=100mm, AO Connector Spiral Drill, D=1.8mm, L=100mm, AO Connector Guide Wire, Steel, D=1.2mm, L=180mm, TR, w. thread Screws - Calcaneus Locking Plate 32351-XX Spiral Drill, D=2.7mm, L=100mm, AO Connector Cancellous Screw, locking, D=4.2mm, SH Spiral Drill, D=2.5mm, L=110mm, AO Connector

Properties Properties of the material: • Plate material: Titanium • Material of screws: TiAl6V4 ELI • Easier removal of the implant after the fracture has healed • Improved fatigue strength of the implant • Reduced risk of cold welding • Reduced risk of inflammation and allergy • Multi-directional locking • Anatomical plate design • Minimization of soft tissue irritation due to anatomical plate design • K-Wire holes for preliminary plate fixation • FLS Plate Straight, Square, L-Shape, L-Shape Extended, L-Shape Extended 1mm Step, MTP, T-Shape: Sliding hole with compression option (to create tension)...

Straight Curved L-Shape L-Shape Extended T-Shape T-Shape Extended MTP L-Shape Extended L-Shape Extended L-Shape Extended T-Shape T-Shape Extended H-Shape Straight Curved L-Shape L-Shape Extended T-Shape T-Shape Extended MTP Calcaneus Plate ♦ Existing infections in the fracture zone and operation area ♦ Common situations that do not allow osteosynthesis ♦ With advanced osteoporosis ♦ Skin and soft-tissue problems which prevent a tension-free closure of the skin ♦ Lack of patient compliance

Surgical Technique

FLS Plate L-Shape Example of use of a FLS Plate L-Shape at a tarsometatarsal joint IV arthrodesis. Temporary fixation with K-Wires • After an anatomical reduction of the fracture segments is achieved, the implant is chosen and if required, its shape can be further contoured • Temporary fixation of the plate using guide wires, Steel, D=1.2mm, L=180mm, TR, w. thread (35124-180) • Subsequent control under fluoroscopy

Placement of the screws Use the spiral drill to drill through the drill guide, D=2.0/2.4mm (62215) (bore diameter depends on the choice of screw). Determine appropriate length using the depth gauge, PROlock II (59026).

Then insert one of the four screwtypes with the Torque-Shank screwdriver, T9x100, AO Connector (54095-100). Afterwards the remaining plate holes are filled, with either locking or non-locking screws. Subsequent control of plate position under fluoroscopy.

Postoperative treatment • Elevation and preventative edema measures on the day of the operation • Mobilization with forefoot relief shoe • Free weightbearing according to symptoms and stipulations of the operating surgeon Explantation • Removal is possible, if desired by the patient. This is facilitated by the fact that cold welding never occurs. • Implant removal is performed after radiographic verification, vice versa of implantation • Skin incision following the old scar • Remove the screws with the Torque-Shank screwdriver, T9x100 (54095-100) • The problem of cold welding was resolved by...

Locking Locking works because: • Screw material (TiAlV) is slightly harder than plate material (Titanium Grade 2) • Screw head forms thread into the plate (no cutting) ± 15° and Locking No pre threading No cold welding No debris You can re-set the screw up to 3 times Dotize® Chemical process - anodization in a strong alkaline solution* Type III anodization Dotize Type II anodization + Film becomes an interstitial part of the titanium - Implant surface remains sensitive to: Chipping Peeling Discoloration Type - III - No visible cosmetic effect Dotize® Type - II Ti-Oxid Anodization Type II leads...

Order list FLS Plate, MTP, Right 21471 FLS Plate, MTP, Left 21472 FLS Plate, Curved, 4-hole 21413-4 FLS Plate, Curved, 5-hole, Right 21411-5 FLS Plate, Curved, 5-hole, Left 21412-5 FLS Plate, Curved, 6-hole 21413-6 FLS Plate, Straight, 5-hole, Short 21421-5 FLS Plate, Straight, 5-hole, Long 21422-5 FLS Plate, Straight, 6-hole 21421-6 FLS Plate, H-Shape, Small 21431-SM FLS Plate, H-Shape, Medium 21431-ME FLS Plate, H-Shape, Large 21431-LA FLS Plate, Square 21451-29 FLS Plate, L-Shape, Right 21441 FLS Plate, L-Shape, Left 21442 FLS Plate, L-Shape Extended, Right 21483 FLS Plate, L-Shape Extended,...