ORTHOFIX External Fixation System (Pennig Minifixators Pennig Dynamic Wrist Fixator & MiniRail System)

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

OPTO SYSTEMS (S) PTE. LTD.

Class:

Class C medical device

Manufactured by:

Orthofix S.r.l.

Therapeutic area:

Orthopaedics

Therapeutic indications:

The Orthofix External Fixation System consists of a series of monolateral or circular fixators intended to be used in conjunction with Orthofix bone screws, threaded wires or Kirschner wires and the Fragment Fixation System. These devices are intended as a means to stabilize bone segments in a broad range of indications, including fractures, joint fusion, joint dislocation, bone transport, lengthening and angular corrections. Pennig Minifixators are intended for fractures, corrective osteotomies, non-unions, soft tissue distraction or bone lengthening in the hand and foot. Pennig Dynamic Wrist Fixator is intended for trans-articular and extra-articular applications for distal radius fractures and corrective osteotomies. MiniRail System is used for lengthening with option for articulation to maximize mobility.

Product summary:

Device System Info:[Sterile Medical Device], Orthofix provides certain external fixation devices STERILE while others are provided NON-STERILE. Devices or kits provided STERILE are labelled as such.; Models: < PENNIG MINIFIXATORS > - null01, PMF THREADED WIRES D 1.6 MM STERILE LENGTH 70/15 MM (PACK OF 4) - 99-M420, PMF THREADED WIRES D 2.0 MM STERILE LENGTH 100/15 MM (PACK OF 4) - 99-M426, PENNIG MINIFIXATOR, SHORT, BODY - M402, PENNIG MINIFIXATOR, STD, BODY - M403, PENNIG MINIFIXATOR LONG BODY - M404, PENNIG MINIFIXATOR SHORT KIT - M405, PENNIG MINIFIXATOR STD KIT - M406, PENNIG MINIFIXATOR LONG KIT - M407, PMF, EXTRA LONG BODY - M408, L-CLAMPS (LEFT/RIGHT SET) FOR PENNIG MINIFIXATOR - M410, CLAMPS, STANDARD, (ONE PAIR) FOR PENNIG MINIFIXATOR - M411, NUT, COMPRESSION/DISTRACTION - M412, CLAMP, LOCKING SCREW FOR PENNIG MINIFIXATOR - M413, LENGTHENING BAR, SHORT, 80 MM FOR PENNIG MINIFIXATOR - M415, LENGTHENING BAR, STD, 100 MM FOR PENNIG MINIFIXATOR - M416, LENGTHENING BAR, LONG, 120 MM FOR PENNIG MINIFIXATOR - M417, PENNIG MINIFIXATOR SPACER - M418, PMF, THREADED WIRES, D 1.6 MM LENGTH 70/15 MM (PACK OF 4) - M420, PMF, THREADED WIRES, D 2.0 MM LENGTH 100/15 MM (PACK OF 4) - M426, REDUCTION FORCEPS (2 PAIRS) FOR PENNIG MINIFIXATOR - M441, THREADED, WIRE EXTRACTOR - M442, PENNIG MINIFIXATOR STERI BOX EMPTY - M443, PMF EXTRA LONG BODY - SSM408, PMF LENGTHENING BAR 150 MM - SSM419, PMF, 3MM SCREW CLAMP (PAIR) - SSM451, MINI PENNIG ARTICULATED BODY - SSM453, < PENNIG DYNAMIC WRIST FIXATOR > - null02, PENNIG WRIST FIXATOR TEMPLATE WITH HANDLE - 13520, DRILL GUIDE DIAMETER 2.7 MM - 13530, DRILL GUIDE DIAMETER 2.0 MM - 13531, PILOT WIRE GUIDE D 1.6 MM - 13532, TAPERED TROCAR - 13540, DRILL BIT KIT DIAMETER 2.7 MM LENGTH 127 MM - 13550, DRILL BIT DIAMETER 2.7 MM LENGTH 127 MM - 1355001, DRILL BIT KIT DIAMETER 2.0 MM LENGTH 127 MM - 13551, DRILL BIT DIAMETER 2.0 MM LENGTH 127 MM - 1355101, DRILL BIT STOP UNIT D 2 MM - 13552, WRIST KIT FOR SMALL METACARPAL - 13555, PENNIG CORTICAL SCREW 70/20 MM SHAFT D 4MM THREAD D 3.3-3.0MM - 35100, PENNIG CORTICAL SCREW 80/35 MM SHAFT D 4MM THREAD D 3.3-3.0MM - 35101, PENNIG CORTICAL SCREW 70/20 MM SHAFT D 4MM THREAD D 3.0-2.5MM - 35156, STERILIZABLE SCREW COVER FOR PENNIG (PACK OF 20) - 35200, PENNIG CORTICAL SCREW 70/20 MM STERILE SHAFT D 4MM THREAD D 3.3-3.0MM - 99-35100, PENNIG CORTICAL SCREW 80/35 MM STERILE SHAFT D 4MM THREAD D 3.3-3.0MM - 99-35101, PENNIG CORTICAL SCREW 70/20 MM STERILE SHAFT D 4MM THREAD D 3.0-2.5MM - 99-35156, SPECIAL PENNIG SCREW GUIDE - SS13521, SPECIAL PENNIG I STRAIGHT CLAMP - SS35540, SELFDRILLING PIN 70/20 MM THREAD DIA. 3.3/3 MM - SS36104, T-WRENCH FOR CLAMP SCREWS - 13570, PENNIG DYNAMIC WRIST FIXATOR ASSEMBLY TEMPLATE KIT - 13700, PENNIG DYNAMIC WRIST FIXATOR TEMPLATE/CONVERSION CLAMP - 13710, KIRSCHNER WIRE (PACK OF 2) LENGTH 150 MM DIAMETER 1.5 MM - 13715, PENNIG STERI BOX EMPTY - 13760, PENNIG DYNAMIC WRIST FIXATOR - 37000, PENNIG DYNAMIC WRIST FIXATOR WITH CD UNIT - 37001, PENNIG DYNAMIC WRIST FIXATOR FOR EXTRA ARTICULAR FRACTURES - 37002, CAM PENNIG DYNAMIC WRIST FIXATOR - 37004, BUSH PENNIG DYNAMIC WRIST FIXATOR - 37005, RE-PACK KIT PENNIG DYNAMIC WRIST FIXATOR - 37006, SHORT MODULE (COMPLETE) PENNIG DYNAMIC WRIST FIXATOR - 37010, SHORT MODULE WITH T-CLAMP PENNIG DYNAMIC WRIST FIXATOR - 37011, LONG MODULE (COMPLETE) PENNIG DYNAMIC WRIST FIXATOR - 37020, DOUBLE BALL-JOINT PENNIG DYNAMIC WRIST FIXATOR - 37030, STRAIGHT CLAMP PENNIG DYNAMIC WRIST FIXATOR - 37040, ULNAR OUTRIGGER CLAMP PENNIG DYNAMIC WRIST FIXATOR - 37050, COMPR/DISTR.MODULE COMPLETE PENNIG DYNAMIC WRIST FIXATOR - 37060, EXTRA ARTICULAR RADIOLUCENT WRIST CLAMP - 37070, RE-USE KIT (3 CLAMP COVER SCREWS) - 37071, CLAMP COVER/ANCHORING SCREW PENNIG DYNAMIC WRIST FIXATOR - 37080, T-CLAMP PENNIG DYNAMIC WRIST FIXATOR - 37090, SELF-DRILL PENNIG CORT. SCREW L 60/20 MM THREAD D 3.3-3.0 MM - 37100, SELF-DRILL PENNIG CORT. SCREW L 70/30 MM THREAD D 3.3-3.0 MM - 37101, SELF-DRILL PENNIG CORT. SCREW L 100/30 MM THREAD D 3.3-3 MM - 37102, SELF-DRILL PENNIG CORT. SCREW STERILE L 60/20 MM THREAD D 3.3-3.0 MM - 99-37100, SELF-DRILL PENNIG CORT. SCREW STERILE L 70/30 MM THREAD D 3.3-3.0 MM - 99-37101, SELF-DRILL PENNIG CORT. SCREW STERILE L 100/30 MM THREAD D 3.3-3 MM - 99-37102, PENNIG II WRIST FIX. WITH C/D MODULE EXTRA SHORT - SS110100, SCREW GUIDE PEDIATRIC FIX.STRAIGHT CONF. - SS13720, SCREW GUIDE PEDIATRIC FIX.T CONFIGURAT. - SS13721, SPECIAL PENNIG COMPR/DISTR.MOD.L150MM - SS221100, SPECIAL PENNIG COMPR/DISTR.MOD.L170MM - SS231100, PEDIATRIC FIXATOR STRAIGHT CONFIGURATION - SS37003, PEDIATRIC FIXATOR T CONFIGURATION - SS37007, SELFDRILLING CORTICAL SCREW 90/20 MM THREAD DIA.3.3-3 MM - SS37103, SPECIAL PENNIG CLAMP KIT - SS37540, SPECIAL ULNA CLAMP - SS37550, PENNIG COMPRESSION DISTRACTION MODULE L.150 MM - SS37560, PIN GUIDE RADIOLUCENT FIXATOR - 13620, ALLEN WRENCH 4 MM - 36017, SELFDRILLING PIN 70/20 MM THREAD DIA. 3.3/3 MM - 36104, SELFDRILLING PIN 80/25 MM THREAD DIA. 3.3/3 MM - 36105, RADIOLUCENT WRIST FIXATOR KIT BASIC SYSTEM - STERILE - 99-36000, RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM - STERILE - 99-36501, RADIOLUCENT WRIST FIXATOR STERILE - 99-36600, RADIOLUCENT WRIST FIXATOR AND SCREWS - STERILE - 99-36601, EXTRA SHORT RADIOLUCENT FIXATOR - SS36900, RADIOLUCENT WRIST FIXATOR KIT STERILE, WITH COATED SCREWS - SS99-36502, < MINIRAIL SYSTEM > - null03, CALCANEAL MINIFIXATOR KIT STERILE - 99-M1450, MINIRAIL, STANDARD, LENGTHENER - M101, MINIRAIL LONG LENGTHENER - M102, MINIRAIL, SHORT, LENGTHENER - M103, MINIRAIL, LENGTHENER, T-CLAMP - M104, ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS - M111, MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS - M122, MINIRAIL LENGTHENER & FIXATOR CLAMP COVER SCREW - M132, PLATE LOCKING SCREW - M135, MINIRAIL LENGTHENER & FIXATOR CLAMP COVER - M138, CALCANEAL MINIFIXATOR - M145, MINIRAIL SYSTEM STERI BOX EMPTY - M190, MINI RAIL, NON-SWIVEL, CLAMP COVER - M203, T-WRENCH FOR BONE SCREWS - M210, DRIVER FOR 3MM SHAFT SCREWS - M211, SCREW FORCEPS - M220, CALCANEAL TEMPLATE KIT - M224, MINIRAIL TEMPLATE KIT, PKG OF 4 - M225, M2 MULTIPLANAR MINIRAIL - M511, ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS - DOUBLE SLIDE - M514, BILATERAL MINILENGTHENER L.85 MM - SS150500, BILATERAL MINILENGTHENER L.110 MM - SS160500, BILATERAL MINILENGTHENER L.145 MM - SS170500, BILATERAL MINILENGTHENER L.173 MM - SS180500, MINIRAIL, SHORT - SSM160, MINILENGTHENER TRIPLE CLAMPS - SSM501, ARTICULATED MINIRAIL FIXATOR WITH HINGE - SSM512, MICROMETRIC ARTICULATED MINIRAIL FIXATOR HORIZ.AXIS - SSM513, SPECIAL MINIRAIL SHORT LENGHTNER - SSM515, ARTICULATED MINIFIXATOR FOR ARTICULAR RIGIDITY - SSM516, MINISANDWICH CLAMP KIT - SSM538, CALCANEUM FIXATOR - M140

Authorization date:

2011-08-16