Company · US
Synthes (USA) Products LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2026. Name variants (Inc, Corp, punctuation) are merged.
61510(k) clearances (1 in 12 months)
164recalls (2 in 12 months)
108recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HTO | Reamer | 36 |
| HRS | Plate, Fixation, Bone | 24 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 17 |
| HWC | Screw, Fixation, Bone | 16 |
| MQP | Spinal Vertebral Body Replacement Device | 15 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 12 |
| MQN | External Mandibular Fixator And/Or Distractor | 9 |
| JDR | Staple, Fixation, Bone | 7 |
| JEY | Plate, Bone | 7 |
| GXQ | Dura Substitute | 6 |
| FSM | Tray, Surgical, Instrument | 5 |
| LXH | Orthopedic Manual Surgical Instrument | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 5 |
| JDS | Nail, Fixation, Bone | 4 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 4 |
| MQV | Filler, Bone Void, Calcium Compound | 4 |
| GAD | Retractor | 3 |
| DZL | Screw, Fixation, Intraosseous | 2 |
| FZX | Guide, Surgical, Instrument | 2 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 11, 2026 | K254087 | MAXFRAME AUTOSTRUT with Bluetooth Multi-Axial Correction System Synthes (USA) Products, LLC | KTT |
| Jan 28, 2022 | K212943 | SyntheCel Dura Repair Synthes (USA) Products, LLC | GXQ |
| May 25, 2021 | K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) Synthes (USA) Products, LLC | KTT |
| Apr 8, 2021 | K210408 | DePuy Synthes Variable Angle Locking Patella Plating System Synthes (USA) Products, LLC | HRS |
| Mar 26, 2021 | K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System Synthes (USA) Products, LLC | HRS |
| Sep 23, 2020 | K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm Synthes (USA) Products, LLC | HSB |
| Sep 18, 2020 | K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional Synthes (USA) Products, LLC | GXN |
| Sep 10, 2020 | K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) Synthes (USA) Products, LLC | JEY |
| Sep 9, 2020 | K201578 | DePuy Synthes Variable Angle Locking Patella Plating System Synthes (USA) Products, LLC | HRS |
| Sep 3, 2020 | K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm Synthes (USA) Products, LLC | JDS |
| Feb 26, 2020 | K191463 | DePuy Synthes Hammertoe Continuous Compression Implant Synthes (USA) Products, LLC | JDR |
| Dec 30, 2019 | K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional Synthes (USA) Products, LLC | JEY |
| Nov 7, 2019 | K192327 | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile Synthes (USA) Products, LLC | HRS |
| Jul 23, 2019 | K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional Synthes (USA) Products, LLC | HRS |
| Mar 13, 2019 | K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional Synthes (USA) Products, LLC | FTM |
| Mar 13, 2019 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional Synthes (USA) Products, LLC | MQN |
| Nov 21, 2018 | K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws Synthes USA Products, LLC | HWC |
| Oct 19, 2018 | K180213 | Titanium TomoFix Medial High Tibia Plate Anatomical Synthes (USA) Products, LLC | HRS |
| Oct 16, 2018 | K182154 | Depuy Synthes Femoral Neck System Synthes (USA) Products, LLC | KTT |
| Jul 24, 2018 | K180544 | DePuy Synthes Static Staples Synthes (USA) Products, LLC | JDR |
| Dec 7, 2017 | K170818 | Craniomaxillofacial Distraction System (CMFD) Synthes USA Products, LLC | PBJ |
| Nov 14, 2017 | K172157 | DePuy Synthes Femoral Recon Nail System Synthes (USA) Products, LLC | HSB |
| Sep 28, 2017 | K170802 | TRAUMACEM V+ Injectable Bone Cement Synthes (USA) Products, LLC | LOD |
| May 8, 2017 | K162594 | Craniomaxillofacial Distraction System (CMFD) Synthes USA Products, LLC | MQN |
| Mar 29, 2017 | K170654 | USS System Synthes USA Products, LLC | NKB |
| Feb 16, 2017 | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm C Synthes USA Products, LLC | HWC |
| Jan 18, 2017 | K153587 | Taps for Resorbable Screws Synthes (USA) Products, LLC | HBG |
| Nov 3, 2016 | K161590 | MatrixRIB Fixation System Synthes (USA) Products, LLC | HRS |
| Nov 1, 2016 | K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System Synthes USA Products, LLC | MAX |
| Sep 26, 2016 | K160167 | DePuy Synthes TFNA Augmentation System Synthes (USA) Products, LLC | HSB |
| Aug 21, 2015 | K150673 | SYNFIX Evolution Secured Spacer System Synthes (USA) Products, LLC | OVD |
| Jun 23, 2015 | K150796 | Dental Bone Cutting Instruments Synthes (USA) Products, LLC | DZJ |
| Jun 18, 2015 | K151276 | DePuy Synthes T-PAL Ti Spacer Synthes USA Products, LLC | MAX |
| May 28, 2015 | K143285 | Mandible External Fixator - MR Conditional Synthes USA Products, LLC | MQN |
| Mar 23, 2015 | K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws) Synthes (USA) Products, LLC | HRS |
| Jan 20, 2015 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System Synthes USA Products, LLC | NKG |
| Oct 17, 2014 | K141165 | MATRIXWAVE MMF SYSTEM Synthes (USA) Products, LLC | JEY |
| Sep 25, 2014 | K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM Synthes USA Products, LLC | KWP |
| Aug 29, 2014 | K141796 | DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM Synthes (USA) Products, LLC | HRS |
| Aug 14, 2014 | K130720 | SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM Synthes (USA) Products, LLC | KCT |
| Aug 7, 2014 | K141241 | MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM Synthes (USA) Products, LLC | HRS |
| Jun 13, 2014 | K140462 | MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) Synthes (USA) Products, LLC | GWO |
| May 2, 2014 | K133616 | MATRIXRIB FIXATION SYSTEM Synthes (USA) Products, LLC | HRS |
| Feb 28, 2014 | K131548 | SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM Synthes (USA) Products, LLC | HSB |
| Jan 16, 2014 | K133698 | SYNAPSE SYSTEM Synthes USA Products, LLC | KWP |
| Jan 6, 2014 | K131276 | LATERAL SYNFIX Synthes (USA) Products, LLC | OVD |
| Dec 16, 2013 | K132910 | DEPUY SYNTHES SPINE DENS ACCESS SYSTEM Synthes USA Products, LLC | HWC |
| Oct 8, 2013 | K131186 | SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM Synthes (USA) Products, LLC | HRS |
| May 24, 2013 | K122639 | SYNTHES SYNCAGE EVOLUTION SPACER Synthes (USA) Products, LLC | MAX |
| Jan 8, 2013 | K123180 | FALCON SPACER Synthes (USA) Products, LLC | MAX |
Newest 50 of 61.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2026 | Synthes (USA) Products LLC 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. Open, Classified |
HWX | None listed |
| Mar 30, 2026 | Synthes (USA) Products LLC 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. Open, Classified |
HWX | None listed |
| Oct 21, 2025 | Synthes (USA) Products LLC LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS.
Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail
Advanced System. Open, Classified |
JDS | K201336 K201346 |
| Oct 21, 2025 | Synthes (USA) Products LLC LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS.
Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail
Advanced System. Open, Classified |
JDS | K201336 K201346 |
| May 28, 2024 | Synthes (USA) Products LLC STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery.
Part Number: 03.130.010 Open, Classified |
HXX | None listed |
| Mar 1, 2024 | Synthes (USA) Products LLC Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease
Part Number: 08.803.231S Open, Classified |
N/A | None listed |
| Mar 1, 2024 | Synthes (USA) Products LLC VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments.
Part Number: 02.112.621S Open, Classified |
HRS | K201321 |
| Mar 1, 2024 | Synthes (USA) Products LLC TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.144S Open, Classified |
HSB | K131548 K160167 |
| Mar 1, 2024 | Synthes (USA) Products LLC TFNA Femoral Nail 9mm, right, 130, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.944S Open, Classified |
HSB | K131548 K160167 |
| Mar 1, 2024 | Synthes (USA) Products LLC RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and Open, Classified |
HBW | K141385 |
| Mar 1, 2024 | Synthes (USA) Products LLC RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullar Open, Classified |
HTO | K013527 K042899 +1 |
| Mar 1, 2024 | Synthes (USA) Products LLC 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment
Product Code: 310.25S Open, Classified |
HSZ | None listed |
| Mar 1, 2024 | Synthes (USA) Products LLC 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment
Part Number: 310.15S Open, Classified |
HSZ | None listed |
| Mar 1, 2024 | Synthes (USA) Products LLC 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defec Open, Classified |
HSB | K051678 |
| Mar 10, 2023 | Synthes (USA) Products LLC TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures
Part Number: 04.037.242S Open, Classified |
HSB | K131548 |
| Mar 10, 2023 | Synthes (USA) Products LLC TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.212S Open, Classified |
HSB | K131548 |
| Mar 10, 2023 | Synthes (USA) Products LLC TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures.
Part Number: 04.037.213S Open, Classified |
HSB | K131548 |
| Oct 18, 2022 | Synthes (USA) Products LLC DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 Open, Classified |
JDR | K191463 |
| Oct 18, 2022 | Synthes (USA) Products LLC SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 Open, Classified |
JDR | K142292 |
| Oct 18, 2022 | Synthes (USA) Products LLC SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 Open, Classified |
JDR | K142292 |
| Oct 18, 2022 | Synthes (USA) Products LLC SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and re Open, Classified |
JDR | K142292 |
| Oct 6, 2022 | Synthes (USA) Products LLC Hammertoe Continuous Compression Implant (CCI) Kit
Part Number: 46.239.001 Open, Classified |
JDR | K191463 |
| Apr 7, 2022 | Synthes (USA) Products LLC Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diamet Open, Classified |
KWI | K183618 |
| Dec 22, 2021 | Synthes (USA) Products LLC Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nail Open, Classified |
LXH | None listed |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.032S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.031S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.030S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.029S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument
Part Code: 03.404.028S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.027S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.026S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.025S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.024S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2
STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.023S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.022S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.021S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument
Part Code: 03.404.020S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.019S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.018S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.017S Terminated |
HTO | K013527 K042899 +2 |
| Nov 19, 2020 | Synthes (USA) Products LLC DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument
Part Code: 03.404.016S Terminated |
HTO | K013527 K042899 +2 |
| Sep 21, 2020 | Synthes (USA) Products LLC 3.0MM LOCKING SCREW LOW PROFILE (TI)
Product Number: 495-491 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprin Terminated |
MQP | K041389 |
| Sep 21, 2020 | Synthes (USA) Products LLC STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and Terminated |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (USA) Products LLC STANDARD RING 17MM X 22MM (TI) Product Number: 495-405 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and Terminated |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI)
Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v Terminated |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI)
Product Number: 495-396 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v Terminated |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 17MM X 22MM LATERAL OR ANTERIOR/5 DEG (TI)
Product Number: 495.394 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v Terminated |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI)
Product Number: 495.392 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in v Terminated |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h Terminated |
MQP | K003275 K983766 |
| Sep 21, 2020 | Synthes (USA) Products LLC END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and h Terminated |
MQP | K003275 K983766 |
Newest 50 of 164.