ClearanceBrief
510(k) K080109 ยท KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

SYNTHES (USA) MODULAR BLADE PLATE SYSTEM

ApplicantSynthes (Usa), West Chester PA, US
DecisionSubstantially Equivalent, Mar 20, 2008
ReceivedJan 15, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K080109

DateFirm and productCodeLinked 510(k)
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.550, 50mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.550S, 50mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femu
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.551, 50mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adole
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.551S, 50mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.555, 55mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.555S, 55mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femu
Terminated
None listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.556, 55mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.556S, 55mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femu
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.561, 60mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.561S, 60mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femu
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.565, 65mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.565S, 65mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.566, 65mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.566S, 65mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SysteFor fixation of fractures and osteotomies of the proximal and distal femur
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.570, 70mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.570S, 70mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.571, 70mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.571S, 70mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femu
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.575, 75mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.575S, 75mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.576, 75mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.576S, 75mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade PlatFor fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.580, 80mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.580S, 80mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femu
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.581, 80mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.581S, 80mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femu
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.585S, 85mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.586, 85mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.586S, 85mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femu
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.590S, 90mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.591, 90mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adol
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.591S, 90mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femu
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.595, 95mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.595S, 95mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.596, 95mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate SystemFor fixation of fractures and osteotomies of the proximal and distal femur in adole
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.596S, 95mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femu
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.600, 100mm Spiral Blade, 14mm, Right- Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.600S, 100mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fe
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.601, 100mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.601S, 100mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.605, 105mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ad
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.605S, 105mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fe
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.606, 105mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.606S, 105mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.610, 110mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ad
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.610s, 110mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fe
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.611, 110mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.611S, 110mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ad
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.615S, 115mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fe
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.616, 115mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.616S, 115mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.620, 120mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ad
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.620S, 120mm Spiral Blade, 14mm, Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fe
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.621, 120mm Spiral Blade, 14mm, Left - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in ado
Terminated
KTWNone listed
Feb 16, 2011Synthes USA (HQ), Inc.
02.122.621S, 120mm Spiral Blade, 14mm, Left-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal fem
Terminated
KTWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.