Company · US
Synthes (Usa)
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2026. Name variants (Inc, Corp, punctuation) are merged.
444510(k) clearances (4 in 12 months)
49recalls (0 in 12 months)
28recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 112 |
| JEY | Plate, Bone | 44 |
| HWC | Screw, Fixation, Bone | 34 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 34 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 27 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 17 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 15 |
| MQN | External Mandibular Fixator And/Or Distractor | 15 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 14 |
| DZL | Screw, Fixation, Intraosseous | 13 |
| JDS | Nail, Fixation, Bone | 12 |
| MQV | Filler, Bone Void, Calcium Compound | 11 |
| JDQ | Cerclage, Fixation | 8 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 8 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 6 |
| MNI | Orthosis, Spinal Pedicle Fixation | 6 |
| MQP | Spinal Vertebral Body Replacement Device | 6 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 5 |
| HTN | Washer, Bolt Nut | 5 |
| HTY | Pin, Fixation, Smooth | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2026 | K254093 | DePuy Synthes VOLT Medial Distal Femur 3.5 Plating System Synthes GmbH, CH | HRS |
| Mar 9, 2026 | K260069 | DePuy Synthes VOLT Proximal Tibia 3.5 Plating System Synthes GmbH, CH | HRS |
| Mar 2, 2026 | K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System Synthes GmbH, CH | HRS |
| Nov 12, 2025 | K243715 | Synthes Patient Specific Implants Synthes GmbH, CH | GXN |
| Mar 28, 2025 | K241927 | Synthes Graphic Case & Tray System Synthes GmbH, CH | KCT |
| Jul 26, 2024 | K233994 | VOLT Proximal Humerus 3.5 Plating System Synthes GmbH, CH | HRS |
| May 9, 2024 | K233967 | DePuy Synthes MatrixSTERNUM Fixation System Synthes GmbH, CH | HRS |
| Dec 21, 2018 | K180821 | TruMatch Graft Cage - Long Bone Synthes (Usa), LLC | HRS |
| Nov 10, 2016 | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System Synthes USA, LLC | KTT |
| Dec 2, 2015 | K152239 | Zero-P Natural Plate System Synthes (Usa), LLC | KWQ |
| Mar 30, 2015 | K141527 | DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM Synthes USA | HRS |
| Mar 31, 2014 | K131984 | SYNTHES SYNSONIC ULNA NAIL Synthes (Usa) | HSB |
| Dec 16, 2013 | K131792 | SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY Synthes, Inc. | GXQ |
| Sep 5, 2013 | K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM Synthes | GWO |
| May 20, 2013 | K130146 | SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM Synthes (Usa), LLC | NDN |
| Apr 11, 2013 | K122455 | SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM Synthes | KTT |
| Feb 28, 2013 | K122647 | SYNTHES PATIENT SPECIFIC PLATE Synthes, Inc. | JEY |
| Nov 19, 2012 | K113567 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM Synthes, Inc. | JEY |
| Aug 23, 2012 | K121502 | SYNTHES CURVILINEAR DISTRACTION SYSTEM Synthes, Inc. | MQN |
| Jul 6, 2012 | K121601 | SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE Synthes USA | HRS |
| Jun 29, 2012 | K121574 | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM Synthes, Inc. | JEY |
| Jun 19, 2012 | K112030 | SYNTHES RADIAL HEAD PROSTHESIS SYSTEM Synthes USA, LLC | KWI |
| Jun 18, 2012 | K120854 | SYNTHES VA LCP ANKLE TRAUMA SYSTEM Synthes USA | HRS |
| May 25, 2012 | K120275 | SYNTHES ACIS/VERTEBRAL SPACER CR Synthes (Usa), LLC | ODP |
| May 8, 2012 | K120717 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) Synthes USA | HRS |
| Mar 21, 2012 | K120070 | SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM Synthes USA | HRS |
| Feb 8, 2012 | K120083 | SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) Synthes USA | HSB |
| Jan 9, 2012 | K113071 | SYNTHECEL DURA REPLACEMENT DEVICES Synthes | GXQ |
| Dec 21, 2011 | K113251 | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES Synthes, Inc. | JEY |
| Dec 13, 2011 | K110604 | VBB SYSTEM Synthes | NDN |
| Dec 5, 2011 | K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS Synthes (Usa) | JDS |
| Nov 16, 2011 | K111323 | SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS Synthes, Inc. | KKY |
| Oct 26, 2011 | K112689 | SYNTHES STERNAL FIXATION SYSTEM Synthes, Inc. | HRS |
| Aug 8, 2011 | K111540 | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM Synthes (Usa) | HRS |
| Jul 28, 2011 | K110789 | SYNTHES STERNAL ZIPFIX SYSTEM Synthes (Usa) | JDQ |
| Jul 25, 2011 | K110592 | 3.7MM/5.0MM DYNAMIC LOCKING SCREW Synthes USA | HWC |
| Apr 21, 2011 | K110125 | 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM Synthes USA | HRS |
| Mar 4, 2011 | K110354 | 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM Synthes USA | JDP |
| Mar 2, 2011 | K103002 | SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM Synthes (Usa) | HSB |
| Jan 21, 2011 | K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM Synthes (Usa) | HRS |
| Dec 20, 2010 | K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM Synthes (Usa) | JEY |
| Dec 16, 2010 | K093299 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM Synthes (Usa) | OAT |
| Dec 9, 2010 | K102694 | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES Synthes (Usa) | HRS |
| Sep 15, 2010 | K101536 | 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM Synthes (Usa), LLC | HRS |
| Aug 3, 2010 | K100776 | SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM Synthes (Usa) | HRS |
| Jul 1, 2010 | K100634 | SYNTHES MATRIX SYSTEM Synthes (Usa) | NKB |
| May 11, 2010 | K092812 | SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES Synthes (Usa) | HRS |
| May 11, 2010 | K092190 | SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS Synthes (Usa) | KTT |
| Apr 14, 2010 | K093361 | SYNTHES AIR PEN DRIVE (APD) SYSTEM Synthes (Usa) | HBB |
| Apr 8, 2010 | K100676 | SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL Synthes (Usa) | HRS |
Newest 50 of 444.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2020 | Synthes, Inc. MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, Terminated |
JEY | K042365 |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
| Dec 16, 2019 | Synthes, Inc. 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. Terminated |
HRS | K103243 |
| Mar 19, 2018 | Synthes, Inc. Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants. Terminated |
HWB | None listed |
| Mar 5, 2018 | Synthes, Inc. Flex Arm
Product Usage:
The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm i Terminated |
LXH | None listed |
| Aug 10, 2017 | Synthes USA Norian Drillable Inject Terminated |
MQV | K073303 |
| Aug 10, 2017 | Synthes USA Norian Drillable Inject Terminated |
OIS | K102722 |
| Aug 7, 2017 | Synthes, Inc. LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001
Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments Terminated |
FZX | None listed |
| Jul 16, 2015 | Synthes, Inc. Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to Terminated |
HTO | K111437 |
| Jul 8, 2015 | Synthes, Inc. TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial Terminated |
JDS | K040762 |
| Jun 26, 2015 | Synthes, Inc. DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractur Terminated |
HSB | K040336 |
| Jun 15, 2015 | Synthes, Inc. Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to th Terminated |
FZX | None listed |
| Jun 15, 2015 | Synthes, Inc. 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, Terminated |
HWC | K000684 K050683 |
| Jun 4, 2015 | Synthes, Inc. 3.2 mm Cannulated Drill Bit/ QC 170 mm
2.7 Cannulated Drill Bit/ QC 160 mm
2.0 mm Cannulated Drill Bit / QC 150 mm
there is no indication for Synthes Cannulated Drill Bits which is used with the Synt Terminated |
HTW | None listed |
| May 12, 2015 | Synthes, Inc. TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma. Terminated |
HSB | K131548 |
| Mar 30, 2015 | Synthes, Inc. Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing Sy Terminated |
HSB | K131548 |
| Mar 23, 2015 | Synthes, Inc. Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smo Terminated |
HWE | K043310 |
| Mar 16, 2015 | Synthes, Inc. Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part nu Terminated |
FZX | None listed |
| Mar 10, 2015 | Synthes, Inc. Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is p Terminated |
LXH | None listed |
| Feb 11, 2015 | Synthes, Inc. Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces. Terminated |
MTJ | K113079 |
| Jan 28, 2015 | Synthes, Inc. 2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143)
Intended to be used for bending and/or cutting Mandible Locking Plates. Terminated |
HXW | None listed |
| Jan 23, 2015 | Synthes, Inc. The Synthes Mandible External Fixator; all lots of part nos.:
04.305.003
04.305.004
04.305.005
04.305.010
04.305.011
04.305.012
03.305.006
04.305.100
04.305.101
04.305.102
04.305.103
04.305.128
04.3 Terminated |
MQN | K040169 K050378 |
| Jan 14, 2015 | Synthes, Inc. Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used in the following systems: the Basic Trocar System, Universal Tro Terminated |
GAD | None listed |
| Nov 14, 2014 | Synthes, Inc. 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur Terminated |
HSB | K011857 |
| Oct 20, 2014 | Synthes, Inc. DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715 Terminated |
GAD | None listed |
| Sep 22, 2014 | Synthes, Inc. DePuy Synthes TI Vectra Plates:
TI Vectra-One" Plate 2 Level / 34 mm
part 04.613.184
3337672
TI Vectra" Plate 3 Level / 57 mm
part 04.613.257
lot 3693878
TI Vectra" Plate 4 Level / 64 mm
part Terminated |
KWQ | K050451 K071667 |
| Aug 20, 2014 | Synthes, Inc. DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) Terminated |
MQN | K060138 |
| Aug 19, 2014 | Synthes, Inc. Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set Terminated |
HWC | K951304 |
| Jul 21, 2014 | Synthes, Inc. Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument. Terminated |
LXH | None listed |
| Jul 2, 2014 | Synthes, Inc. Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthope Terminated |
HWC | None listed |
| Jun 19, 2014 | Synthes, Inc. Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components. Terminated |
KTT | K030390 K082650 +3 |
| Jun 11, 2014 | Synthes, Inc. Synthes Matrix Mandible Short Cut Plate Cutter
Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery. Terminated |
HTZ | None listed |
| Jun 2, 2014 | Synthes, Inc. Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used Terminated |
MQP | K103320 |
| May 29, 2014 | Synthes, Inc. Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: Terminated |
GFG | None listed |
| Apr 15, 2014 | Synthes, Inc. The Synthes Hohmann Retractor, 43 mm Long Shank, Angled 235 mm
Product Usage: Used to expose bone for procedures. Terminated |
GAD | None listed |
| Apr 14, 2014 | Synthes, Inc. Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion. Terminated |
GXL | None listed |
| Mar 25, 2014 | Synthes, Inc. Drill Template and the Saw Guide for the Ulna Osteotomy System.
Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, includi Terminated |
HRS | K113364 |
| Mar 11, 2014 | Synthes, Inc. Synthes Small Notch Titanium Reconstructive Plate
Product Usage:
The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercial Terminated |
HRS | K915818 |
| Mar 4, 2014 | Synthes, Inc. Synthes 5.0mm Variable Locking Screw
This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable Terminated |
JDP | K110354 |
| Feb 20, 2014 | Synthes, Inc. Synthes Driving Cap/Threaded
Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the inser Terminated |
LXH | None listed |
| Feb 19, 2014 | Synthes, Inc. Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and Terminated |
FZX | None listed |
| Feb 16, 2014 | Synthes, Inc. Synthes 3.2 mm Guide Wire 400mm.
Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral. Terminated |
LXH | None listed |
| Jan 11, 2012 | Synthes USA SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101.
Bone void filler. Terminated |
MQV | K060408 |
| Sep 21, 2008 | Synthes U S A Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments. Terminated |
GEY | None listed |
| Jan 11, 2007 | Synthes LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465 Terminated |
HRS | K012114 |
| Apr 26, 2006 | Synthes (USA) Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. Terminated |
JEY | None listed |