ClearanceBrief
Company

Synthes USA (HQ), Inc.

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
151recalls (0 in 12 months)
125recalls that name a 510(k)

Product codes

CodeDeviceRecords
KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component57
MQPSpinal Vertebral Body Replacement Device12
LXHOrthopedic Manual Surgical Instrument9
HSBRod, Fixation, Intramedullary And Accessories7
HRSPlate, Fixation, Bone6
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component6
JEYPlate, Bone5
NQPPosterior Metal/Polymer Spinal System, Fusion5
DZLScrew, Fixation, Intraosseous4
NKBThoracolumbosacral Pedicle Screw System4
HWCScrew, Fixation, Bone3
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment3
JDSNail, Fixation, Bone3
GADRetractor2
HTDForceps2
HTWBit, Drill2
KWQAppliance, Fixation, Spinal Intervertebral Body2
FMFSyringe, Piston1
GXPMethyl Methacrylate For Cranioplasty1
HTCPliers, Surgical1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 31, 2013Synthes USA HQ, Inc.
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decort
Terminated
HWEK043310
Dec 10, 2013Synthes USA HQ, Inc.
Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur
Terminated
KTTK023941
Dec 10, 2013Synthes USA HQ, Inc.
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Terminated
HSBK011857
Dec 5, 2013Synthes USA HQ, Inc.
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skele
Terminated
OVEK112068
Dec 5, 2013Synthes USA HQ, Inc.
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Terminated
HSBK011857
Nov 29, 2013Synthes USA HQ, Inc.
Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Terminated
GADNone listed
Nov 27, 2013Synthes USA HQ, Inc.
Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other dev
Terminated
LXHNone listed
Nov 27, 2013Synthes USA HQ, Inc.
Synthes Titanium Cannulated Humeral Nail Intended to aid in the alignment and stabilization of humeral fractures
Terminated
JDSK033071
Nov 27, 2013Synthes USA HQ, Inc.
Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
Terminated
KTTK041911
Nov 27, 2013Synthes USA HQ, Inc.
Vertebroplasty Needle Kit 10g Diamond Tip Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure.
Terminated
OARNone listed
Nov 27, 2013Synthes USA HQ, Inc.
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck frac
Terminated
HTWNone listed
Nov 26, 2013Synthes USA HQ, Inc.
Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: su
Terminated
JDPK110354
Nov 26, 2013Synthes USA HQ, Inc.
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bon
Terminated
HWCK110592
Nov 26, 2013Synthes USA HQ, Inc.
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
Terminated
HTNK011583
Nov 26, 2013Synthes USA HQ, Inc.
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distr
Terminated
LXHNone listed
Nov 26, 2013Synthes USA HQ, Inc.
Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intende
Terminated
HXPNone listed
Nov 26, 2013Synthes USA HQ, Inc.
Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixat
Terminated
NKBK113044
Nov 26, 2013Synthes USA HQ, Inc.
Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior h
Terminated
NKBK113044
Nov 25, 2013Synthes USA HQ, Inc.
Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, in
Terminated
HSBK011857
Nov 25, 2013Synthes USA HQ, Inc.
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphy
Terminated
LXHNone listed
Nov 22, 2013Synthes USA HQ, Inc.
Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior patholo
Terminated
LXHNone listed
Nov 22, 2013Synthes USA HQ, Inc.
2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in
Terminated
HRSK063049
Nov 20, 2013Synthes USA HQ, Inc.
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur in
Terminated
HSBK070294
Nov 18, 2013Synthes USA HQ, Inc.
Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
Terminated
GADNone listed
Nov 13, 2013Synthes USA HQ, Inc.
Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other dev
Terminated
LXHNone listed
Oct 30, 2013Synthes USA HQ, Inc.
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum
Terminated
JDQK110789
Oct 17, 2013Synthes USA HQ, Inc.
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Terminated
HWCK081071
Sep 26, 2013Synthes USA HQ, Inc.
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous l
Terminated
LXHNone listed
Sep 25, 2013Synthes USA HQ, Inc.
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12
Terminated
KTTK033995
Sep 18, 2013Synthes USA HQ, Inc.
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
Terminated
HTYK970733
Aug 26, 2013Synthes USA HQ, Inc.
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other s
Terminated
HRSK083694
Aug 26, 2013Synthes USA HQ, Inc.
Synthes Trauma Nail System. The devices are indication for bone fixation.
Terminated
HSBK011857
K033071 +3
Aug 12, 2013Synthes USA HQ, Inc.
Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.
Terminated
HTONone listed
Aug 9, 2013Synthes USA HQ, Inc.
5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit
Terminated
MNIK020517
Jul 29, 2013Synthes USA HQ, Inc.
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and
Open, Classified
KTTK082650
Jul 29, 2013Synthes USA HQ, Inc.
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical
Terminated
LXHNone listed
Jul 17, 2013Synthes USA HQ, Inc.
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as con
Terminated
DZLK010690
Jul 12, 2013Synthes USA HQ, Inc.
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of th
Terminated
MQNK060138
Jun 19, 2013Synthes USA HQ, Inc.
Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
Terminated
HRSK011335
May 3, 2013Synthes USA HQ, Inc.
Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome compon
Terminated
KWIK112030
Apr 5, 2013Synthes USA HQ, Inc.
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
Terminated
LXHNone listed
Mar 28, 2013Synthes USA HQ, Inc.
Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixatio
Terminated
HWCNone listed
Mar 15, 2013Synthes USA HQ, Inc.
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies
Terminated
HRSK102694
Mar 12, 2013Synthes USA HQ, Inc.
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Terminated
JEYK010499
Mar 11, 2013Synthes USA HQ, Inc.
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures
Terminated
KTTK082650
Mar 11, 2013Synthes USA HQ, Inc.
Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature pati
Terminated
MNHK992739
Mar 1, 2013Synthes USA HQ, Inc.
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.
Terminated
DZLK010690
Mar 1, 2013Synthes USA HQ, Inc.
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
Terminated
DZLK010690
Mar 1, 2013Synthes USA HQ, Inc.
Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Terminated
DZLK010690
Feb 4, 2013Synthes USA HQ, Inc.
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synth
Terminated
KWQK050451
K051665 +1

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