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OSTEOTRANS™ devices
are intended for the following use.
General indications :
1. Repair of bone fracture by osteosynthesis
2. Fixation of bone fragments in bone grafting
3. Fixation of bone fragments in osteotomy
4. Fixation of bone fragments in reconstructive procedures
5. Fixation of ligaments or soft tissues
Specific indications :
- OSTEOTRANS™-OT Screw, Pin, Washer
| 1. |
Repair of bone
fractures
(1) Peri- and intra-articular fractures of the shoulder,
elbow, wrist, hand, hip, knee, ankle and foot.
(2) Small bones in hand and foot |
| 2. |
Fixation of bone fragments
in bone grafting
(1) Bone-graft procedures in total joint arthroplasty
(2) Bone-graft procedures in segmental defect bridging
(3) Bone-graft procedures after excision of bone tumours |
| 3. |
Fixation of bone fragments
in osteotomy
(1) Rotational acetabular osteotomy
(2) Correction osteotomy for hallux valgus
(3) Wrist arthroplasty (Kapanji method)
(4) Temporary fixation of the distal tibio-fibular joint |
- OSTEOTRANS™-OT Interference Screw
ACL and PCL reconstruction surgery
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The OSTEOTRANS™ Interference
Screw is intended for use in interference fixation of bone-patellar
tendon - bone and soft tissue grafts in anterior and posterior
cruciate ligament reconstructions. |
- OSTEOTRANS™-OT Rib/Sternum Pin
| 1. |
Repair of fractures
of rib |
| 2. |
Fixation of bone fragments
of rib and sternum in osteotomy |
- OSTEOTRANS™-MX Plate, Screw, Sheet, Mesh
| 1. |
Repair of fractures
of the craniofacial, midface and mandible skeleton, and
hand, foot and thoracic skeleton |
| 2. |
Fixation of bone fragments
in corrective osteotomy procedures of the craniofacial,
midface and mandible skeleton, and hand, foot and thoracic
skeleton |
| 3. |
Fixation of bone fragments
in bone grafting of the craniofacial, midface and mandible
skeleton, and hand, foot and thoracic skeleton |
The OSTEOTRANS™ System is not intended for use in and is contraindicated
for
| 1) |
Insufficient
quality and quantity of bone
for attachment of graft. |
| 2) |
Blood
supply limitation and/or previous
infections, which could retard
healing. |
| 3) |
Patients
with active infection. |
| 4) |
Conditions,
which tend to limit the patient's
ability or willingness to restrict
activities or follow directions
during the healing and rehabilitation
period. |
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