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
| Code | Device | Records |
|---|---|---|
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 57 |
| MQP | Spinal Vertebral Body Replacement Device | 12 |
| LXH | Orthopedic Manual Surgical Instrument | 9 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 7 |
| HRS | Plate, Fixation, Bone | 6 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 6 |
| JEY | Plate, Bone | 5 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 5 |
| DZL | Screw, Fixation, Intraosseous | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 |
| HWC | Screw, Fixation, Bone | 3 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 3 |
| JDS | Nail, Fixation, Bone | 3 |
| GAD | Retractor | 2 |
| HTD | Forceps | 2 |
| HTW | Bit, Drill | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| FMF | Syringe, Piston | 1 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 |
| HTC | Pliers, Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2013 | Synthes 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 |
HWE | K043310 |
| Dec 10, 2013 | Synthes 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 |
KTT | K023941 |
| Dec 10, 2013 | Synthes 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 |
HSB | K011857 |
| Dec 5, 2013 | Synthes 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 |
OVE | K112068 |
| Dec 5, 2013 | Synthes USA HQ, Inc. Titanium Trochanteric Fixation Nail (TFN)System
Intended to treat stable and unstable fractures of the proximal femur. Terminated |
HSB | K011857 |
| Nov 29, 2013 | Synthes USA HQ, Inc. Synthes Soft Tissue Retractor Small Extendible.
Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion. Terminated |
GAD | None listed |
| Nov 27, 2013 | Synthes 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 |
LXH | None listed |
| Nov 27, 2013 | Synthes USA HQ, Inc. Synthes Titanium Cannulated Humeral Nail
Intended to aid in the alignment and stabilization of humeral fractures Terminated |
JDS | K033071 |
| Nov 27, 2013 | Synthes USA HQ, Inc. Synthes 4.5 mm LCP Curved Condylar Plate
Intended for buttressing multifragmentary distal femur fractures. Terminated |
KTT | K041911 |
| Nov 27, 2013 | Synthes USA HQ, Inc. Vertebroplasty Needle Kit 10g Diamond Tip
Intended to be used to inject PMMA cement into vertebral bodies during Vertebroplasty procedure. Terminated |
OAR | None listed |
| Nov 27, 2013 | Synthes 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 |
HTW | None listed |
| Nov 26, 2013 | Synthes 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 |
JDP | K110354 |
| Nov 26, 2013 | Synthes 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 |
HWC | K110592 |
| Nov 26, 2013 | Synthes 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 |
HTN | K011583 |
| Nov 26, 2013 | Synthes 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 |
LXH | None listed |
| Nov 26, 2013 | Synthes 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 |
HXP | None listed |
| Nov 26, 2013 | Synthes 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 |
NKB | K113044 |
| Nov 26, 2013 | Synthes 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 |
NKB | K113044 |
| Nov 25, 2013 | Synthes 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 |
HSB | K011857 |
| Nov 25, 2013 | Synthes 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 |
LXH | None listed |
| Nov 22, 2013 | Synthes 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 |
LXH | None listed |
| Nov 22, 2013 | Synthes 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 |
HRS | K063049 |
| Nov 20, 2013 | Synthes 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 |
HSB | K070294 |
| Nov 18, 2013 | Synthes USA HQ, Inc. Synthes Soft Tissue Retractor Small Extendible
Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion. Terminated |
GAD | None listed |
| Nov 13, 2013 | Synthes 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 |
LXH | None listed |
| Oct 30, 2013 | Synthes 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 |
JDQ | K110789 |
| Oct 17, 2013 | Synthes 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 |
HWC | K081071 |
| Sep 26, 2013 | Synthes 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 |
LXH | None listed |
| Sep 25, 2013 | Synthes 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 |
KTT | K033995 |
| Sep 18, 2013 | Synthes USA HQ, Inc. Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device. Terminated |
HTY | K970733 |
| Aug 26, 2013 | Synthes 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 |
HRS | K083694 |
| Aug 26, 2013 | Synthes USA HQ, Inc. Synthes Trauma Nail System. The devices are indication for bone fixation. Terminated |
HSB | K011857 K033071 +3 |
| Aug 12, 2013 | Synthes USA HQ, Inc. Synthes Flexible Medullary Reamer.
Intended to be used to facilitate the preparation of the intramedullary cavity. Terminated |
HTO | None listed |
| Aug 9, 2013 | Synthes 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 |
MNI | K020517 |
| Jul 29, 2013 | Synthes 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 |
KTT | K082650 |
| Jul 29, 2013 | Synthes 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 |
LXH | None listed |
| Jul 17, 2013 | Synthes 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 |
DZL | K010690 |
| Jul 12, 2013 | Synthes 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 |
MQN | K060138 |
| Jun 19, 2013 | Synthes USA HQ, Inc. Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011 Terminated |
HRS | K011335 |
| May 3, 2013 | Synthes 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 |
KWI | K112030 |
| Apr 5, 2013 | Synthes 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 |
LXH | None listed |
| Mar 28, 2013 | Synthes 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 |
HWC | None listed |
| Mar 15, 2013 | Synthes 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 |
HRS | K102694 |
| Mar 12, 2013 | Synthes 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 |
JEY | K010499 |
| Mar 11, 2013 | Synthes 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 |
KTT | K082650 |
| Mar 11, 2013 | Synthes 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 |
MNH | K992739 |
| Mar 1, 2013 | Synthes USA HQ, Inc. Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967.
For mandibular bone lengthening. Terminated |
DZL | K010690 |
| Mar 1, 2013 | Synthes USA HQ, Inc. Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966.
For mandibular bone lengthening. Terminated |
DZL | K010690 |
| Mar 1, 2013 | Synthes USA HQ, Inc. Synthes Multi-Vector Distractor Body, Part Number 487.931.
For mandibular bone lengthening. Terminated |
DZL | K010690 |
| Feb 4, 2013 | Synthes 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 |
KWQ | K050451 K051665 +1 |
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