as-1102-pl-e0 b 02-13_layout 1 - orthofix abs

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SUCCESS RATE % 88% 85% 80% 85% 0-3mm 3-6mm Overall Fracture Gap Overall Registry Data PMA Study Physio-Stim ® model 3202CE Elbow fixator Treatment of Bilateral Elbow Dislocation Using External Fixation With Motion Capacity. Koslowsky TC, Mader K, Siedek M, Pennig D. J Orthop Trauma 2006;20:499–502 Unilateral hinged external fixator of the elbow in complex elbow injuries. Stavlas P, Gliatis J, Polyzois V, Polyzois D. Injury (2004) 35, 1158-1166 Mechanical distraction for the treatment of posttraumatic stiffness of the elbow in children and adolescents. Surgical technique. Mader K, Koslowsky TC, Gausepohl T, Pennig D. J Bone Joint Surg Am. 2007 Mar;89 Suppl 2 Pt.1:26-35. FFS Evaluation of compression generated by self compressing Orthofix bone pins and lag screws in simulated lateral humeral condylar fractures. Doubts BM, McLaughlin RM, Silverman E, Rizon J. Vet Comp Orthop Traumatol 2007; 20: 175-179. Mini Pennig Gradual joint distraction of post-traumatic flexion contracture of the proximal interphalangeal joint by a mini- external fixator. Houshian S, Chikkamuniyappa C, Schroeder H. J Bone Joint Surg [Br] 2007;89-B:206-9 Management of intra-articular fracture of the fingers via mini external fixator combined with limited internal fixation. Li WJ, Tian W, Tian GL, Chen SL, Zhang CQ, Xue YH, Li ZZ, Zhu Y. Chin Med J (Engl). 2009 Nov 5;122(21):2616-9. Minirail Management of hallux limitus with distraction of the first metatarsophalangeal joint. Talarico LM, Vito GR, Goldstein L, Perler AD. J Am Podiatr Med Assoc. 2005 Mar-Apr;95(2):121-9. Osteotite Bone Screws Evaluation of surgical repair of humeral condylar fractures using self-compressing orthofix pins in 23 dogs. Guille AE, Lewis DD, Anderson TP, Beaver DP, Carrera-Justiz SC, Thompson MS, Wheeler JL. Vet Surg. 2004 Jul- Aug;33(4):314-22. Biomechanical comparison of orthofix pins and cortical bone screws in a canine humeral condylar fracture model. Vida JT, Pooya H, Vasseur PB, Garcia TC, Schulz K, Stover SM. Vet Surg. 2005 Sep-Oct;34(5):491-8. Pennig Dynamic Wrist Fixator Principles of external fixation and supplementary techniques in distal radius fractures. Gausepohl T, Pennig D, Mader K. Injury 2000;31:56-70. Results of transarticular fixator application in distal radius fractures. Klein W, Deaeb H, Riegerc HS, Neumanna U, Joosten C. Injury, Int. J. Care Injured 31 (2000) 71-77. Physio-Stim ® Long-term follow-up of fracture nonunions treated with PEMFs. Garland DE, Moses B, Salyer W. Contemp Orthop. 1991 Mar;22(3):295-302. Radiolucent Dynamic Wrist Fixator The radiolucent wrist fixator for distal radius fractures. Nelson. “Orthofix external fixation in Trauma and Orthopaedics” - G. De Bastiani, A.G. Apley and A: Goldberg (Eds), Springer 2000. Contours VPS - Volar plating System ® Volar plating of distal radius fractures using a locked anatomically contoured plate. Gallacher PD, Gilbert R, Memon S, Bohoora IG. Eur J Orthop Surg Traumatol 2009. Elbow, Forearm, Wrist & Hand Indications Primary Treatment Sites: Right and Left Elbow, Forearm, Wrist and Hand Succes Rates The effect of Physio-Stim PEMF on fracture non-unions was demonstrated in an open trial PMA study which followed 181 patients with 193 fractures who had not healed on their own after nine or more months. In addition, Orthofix Patient Registry Data of 729 patients presenting 859 individual fractures treated with Physio-Stim resulted in the following outcomes. (1, 2) 1. PMA P850007/S20 2. PMA P850007 ANATOMICAL SOLUTIONS Indications Fixation in cortical, cancellous and osteoporotic bone Advantages • Hydroxyapatite coating enhances osteointegration • Cortical bone screw and self drilling cortical bone screw available • Enhanced fixation and reduced pin loosening • Reduced incident of pin track infection Osteotite Bone Screws Indications Distal radius fractures Advantages • Fracture visualisation, unobstructed view of radius and carpals • Ball-joint design helps anatomical reduction • Low profile design for patient comfort • Compression-distraction unit for reduction • Telescoping radiolucent body • Ready to use fixator in sterile kit including required instrumentation, compression-distraction unit and standard bone screws Indications Trans-articular and extra articular applications for distal radius fractures and corrective osteotomies Advantages • Low profile design for patient comfort • Cam design indicates locking position • Strong double ball-joint, matched to radio-carpal anatomy, for fracture reduction in all planes, to maintain reduction until healing and for early mobilisation of wrist joint if desired Radiolucent Dynamic Wrist Fixator Pennig Dynamic Wrist Fixator REFERENCES 0123 Manufactured by: ORTHOFIX Srl Via Delle Nazioni 9, 37012 Bussolengo (Verona), Italy Telephone +39 045 6719000, Fax +39 045 6719380 Physio Stim manufactured by: Orthofix Inc. 3451 Plano Pkwy, Lewisville, Texas 75056 U.S.A. 800-266-3349 214-937-3000 0086 www.orthofix.com AS-1102-PL-E0 E 09/17 Distributed by:

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Page 1: AS-1102-PL-E0 B 02-13_Layout 1 - Orthofix ABS

SUCC

ESS

RATE

% 88% 85% 80% 85%

0-3mm 3-6mm OverallFracture Gap

OverallRegistry Data

PMA Study

Physio-Stim® model 3202CE

Elbow fixator• Treatment of Bilateral Elbow Dislocation Using External Fixation With Motion Capacity. Koslowsky TC, Mader K,

Siedek M, Pennig D. J Orthop Trauma 2006;20:499–502• Unilateral hinged external fixator of the elbow in complex elbow injuries. Stavlas P, Gliatis J, Polyzois V, Polyzois D.

Injury (2004) 35, 1158-1166• Mechanical distraction for the treatment of posttraumatic stiffness of the elbow in children and adolescents.

Surgical technique. Mader K, Koslowsky TC, Gausepohl T, Pennig D. J Bone Joint Surg Am. 2007 Mar;89 Suppl 2 Pt.1:26-35.

FFS• Evaluation of compression generated by self compressing Orthofix bone pins and lag screws in simulated lateral

humeral condylar fractures. Doubts BM, McLaughlin RM, Silverman E, Rizon J. Vet Comp Orthop Traumatol 2007; 20: 175-179.

Mini Pennig• Gradual joint distraction of post-traumatic flexion contracture of the proximal interphalangeal joint by a mini-

external fixator. Houshian S, Chikkamuniyappa C, Schroeder H. J Bone Joint Surg [Br] 2007;89-B:206-9• Management of intra-articular fracture of the fingers via mini external fixator combined with limited

internal fixation. Li WJ, Tian W, Tian GL, Chen SL, Zhang CQ, Xue YH, Li ZZ, Zhu Y. Chin Med J (Engl). 2009 Nov 5;122(21):2616-9.

Minirail• Management of hallux limitus with distraction of the first metatarsophalangeal joint. Talarico LM, Vito GR,

Goldstein L, Perler AD. J Am Podiatr Med Assoc. 2005 Mar-Apr;95(2):121-9.

Osteotite Bone Screws• Evaluation of surgical repair of humeral condylar fractures using self-compressing orthofix pins in 23 dogs.

Guille AE, Lewis DD, Anderson TP, Beaver DP, Carrera-Justiz SC, Thompson MS, Wheeler JL. Vet Surg. 2004 Jul-Aug;33(4):314-22.

• Biomechanical comparison of orthofix pins and cortical bone screws in a canine humeral condylar fracture model. Vida JT, Pooya H, Vasseur PB, Garcia TC, Schulz K, Stover SM. Vet Surg. 2005 Sep-Oct;34(5):491-8.

Pennig Dynamic Wrist Fixator• Principles of external fixation and supplementary techniques in distal radius fractures. Gausepohl T, Pennig D,

Mader K. Injury 2000;31:56-70.• Results of transarticular fixator application in distal radius fractures. Klein W, Deaeb H, Riegerc HS, Neumanna U,

Joosten C. Injury, Int. J. Care Injured 31 (2000) 71-77.

Physio-Stim®

• Long-term follow-up of fracture nonunions treated with PEMFs. Garland DE, Moses B, Salyer W. Contemp Orthop. 1991 Mar;22(3):295-302.

Radiolucent Dynamic Wrist Fixator• The radiolucent wrist fixator for distal radius fractures. Nelson. “Orthofix external fixation in Trauma and

Orthopaedics” - G. De Bastiani, A.G. Apley and A: Goldberg (Eds), Springer 2000.

Contours VPS - Volar plating System®

• Volar plating of distal radius fractures using a locked anatomically contoured plate. Gallacher PD, Gilbert R, Memon S, Bohoora IG. Eur J Orthop Surg Traumatol 2009.

Elbow, Forearm, Wrist & Hand

Indications Primary Treatment Sites: Right and Left Elbow, Forearm, Wrist and Hand

Succes Rates The effect of Physio-Stim PEMF on fracture non-unions was demonstrated in an open trial PMA study which followed 181 patients with 193 fractures who had not healed on their own after nine or more months. In addition, Orthofix Patient Registry Data of 729 patients presenting 859 individual fractures treated with Physio-Stim resulted in the following outcomes. (1, 2)

1. PMA P850007/S202. PMA P850007

ANATOMICAL SOLUTIONS

Indications Fixation in cortical, cancellous and osteoporotic bone

Advantages • Hydroxyapatite coating enhances osteointegration• Cortical bone screw and self drilling cortical bone screw available• Enhanced fixation and reduced pin loosening• Reduced incident of pin track infection

Osteotite Bone Screws

Indications Distal radius fractures

Advantages • Fracture visualisation, unobstructed view of radius and carpals• Ball-joint design helps anatomical reduction• Low profile design for patient comfort• Compression-distraction unit for reduction• Telescoping radiolucent body• Ready to use fixator in sterile kit including required instrumentation, compression-distraction unit and standard bone screws

Indications Trans-articular and extra articular applications for distal radius fractures and corrective osteotomies

Advantages • Low profile design for patient comfort• Cam design indicates locking position• Strong double ball-joint, matched to radio-carpal anatomy, for fracture reduction

in all planes, to maintain reduction until healing and for early mobilisation of wrist joint if desired

Radiolucent Dynamic Wrist Fixator

Pennig Dynamic Wrist Fixator

R E F E R E N C E S

0123

Manufactured by: ORTHOFIX SrlVia Delle Nazioni 9, 37012 Bussolengo (Verona), ItalyTelephone +39 045 6719000, Fax +39 045 6719380

Physio Stimmanufactured by:Orthofix Inc.3451 Plano Pkwy, Lewisville, Texas 75056 U.S.A.800-266-3349214-937-3000

0086

www.orthofix.com AS-1102-PL-E0 E 09/17

Distributed by:

Page 2: AS-1102-PL-E0 B 02-13_Layout 1 - Orthofix ABS

Indications Fractures; aseptic and infected nonunions; corrective osteotomy; lengthening;replantation; soft tissue correction

Advantages • Secure fracture fixation with adjacent joints free to move• Minimally invasive percutaneous wire insertion• Straightforward technique• Versatile

Indications Distal radius fractures

Advantages • Anatomically designed plate to achieve fixed-angle screw placement• Greater selection of screw sizes for stabilizing large and small fragments• Microthreaded screws provide stability and minimize shattering of small fragments• Sophisticated, multiple-function instrumentation

Indications Gradual correction of pediatric elbow deformities: cubitus varus

Contours VPS - Volar Plating System®

Mini-Pennig

Guided Growth System

Galaxy Fixation™ System - Elbow

Indications Intra-articular fractures, fracture-dislocations requiring further stabilisation after treatment, post-traumatic stiffness

Advantages • Stable, controlled movement around the elbow joint axis of rotation• Immediate pronation and supination• Early flexion and extension• Controlled distraction of the joint possible

Elbow Fixator

Indications Fixation of fragments too small for large implants

Advantages • Excellent stability guaranteed by fine thread and unique design• Compression possible between fragments• No pre-drilling or pre-tapping required• Medium and large sizes can be combined with a washer to improve cortical contact• Simplicity saves operative time

Fragment Fixation System

Indications Acute trauma, or lengthening or articulated distraction

Advantages • Lengthening with option for articulation to maximise mobilization• Three screw seats accomodating either 2mm threaded wires or 3mm bone screws• Optional T-clamp attachment for insertion of screws close to the joint at right angle

to the longitudinal axis• Articulation in horizontal or vertical axis

E L B O W , F O R E A R M , W R I S T & H A N DIndications Infected and aseptic non-unions; joint pathologies/injuries; open or closed fractures; elbow stiffness

Advantages Elbow system• Radiolucent hinge allows easy location of the elbow centre of rotation• Free pin placement in any desired plane• Elbow motion unit to be used with the Elbow Central Unit: allows for controlled and or limited extension/flexion of the joint• Intra-operative distraction unit for distraction of the joint in case of elbow stiffness

General system• Fast and easy assembly• Flexibility of use• Single packed sterile kits and components• Stable temporary and definitive fixation• MR conditional

* Up to 3 Tesla, see instruction leaflet (PQ GAL) and Operative Technique (GF-1101-OPT-E0)

For patient:• Outpatient procedure - minimal impact

on school/work schedule• Reduced surgical pain/risks• Immediate mobilization/rehabilitation• Flexible implant will tether (not compress)

the physis, allowing more rapid correction

Advantages For surgeon: • Simple, minimally invasive technique• Learning curve = 1 to 2 cases• Addresses multiple/complex deformities

simultaneously• Modular correction – can be repeated

during growth as indicated

Indications Volar fixation of fractures and osteotomies involving the distal radius

Advantages • Extensive selection of plate sizes• Volar surface designed to accommodate the broad anatomic variances between patients

for a more aligned bone-plate interface• Converging screw pattern for great subchondral support• Sophisticated and complete instrumentation, to accelerate operative time• Wide range of screws• “Key” design allows for a proximal oblong hole - along with a “window” for fracture

visualization and grafting

Contours VPS-3

Indications Open or closed fractures of the long bones; infected and aseptic non-unions; joint pathologies/injuries

Advantages • Fast and easy assembly• Flexibility of use• Single packed sterile kits and components• Stable temporary and definitive fixation• MR conditional*

Galaxy Fixation™ System

* Up to 3 Tesla, see instruction leaflet (PQ GAL)and Operative Technique (GF-1101-OPT-E0)

Indications Intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage, Polytrauma, Carpal dislocations, Unreduced fractures following conservative treatment, Bone-loss or other reconstructive procedures, Infection

Advantages • Early mobilisation option for quick wrist function recovery and patient comfort• Motion range selector (+/- 20°/ 40°) for controlled, limited flexion-extension• Allows for application of combined internal synthesis (i.e. K-wires, FFS, plates and screws)• Radiolucent• Modular components compatible with the Galaxy Fixation System• MRI Conditional*

Galaxy Fixation™ System - Wrist

* At 1.5 and 3 Tesla (see relevant Instructions for Use and Operative Technique)

Minirail