Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Synthes (USA) Products, LLC · Predicate Candidate Screening
61 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
267 days90th percentile
61clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254087 | MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction Sy | Synthes (USA) Products, LLC | 2026-06-11 | 175 | 0 |
| K212943 | SyntheCel Dura Repair | Synthes (USA) Products, LLC | 2022-01-28 | 135 | 0 |
| K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | Synthes (USA) Products, LLC | 2021-05-25 | 25 | 0 |
| K210408 | DePuy Synthes Variable Angle Locking Patella Plating System | Synthes (USA) Products, LLC | 2021-04-08 | 56 | 0 |
| K210205 | DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic P | Synthes (USA) Products, LLC | 2021-03-26 | 59 | 0 |
| K201346 | DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy | Synthes (USA) Products, LLC | 2020-09-23 | 125 | 2 |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditi | Synthes (USA) Products, LLC | 2020-09-18 | 357 | 0 |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (2 | Synthes (USA) Products, LLC | 2020-09-10 | 59 | 0 |
| K201578 | DePuy Synthes Variable Angle Locking Patella Plating System | Synthes (USA) Products, LLC | 2020-09-09 | 90 | 0 |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Sc | Synthes (USA) Products, LLC | 2020-09-03 | 106 | 2 |
| K191463 | DePuy Synthes Hammertoe Continuous Compression Implant | Synthes (USA) Products, LLC | 2020-02-26 | 268 | 2 |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019-12-30 | 96 | 0 |
| K192327 | DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile | Synthes (USA) Products, LLC | 2019-11-07 | 72 | 0 |
| K190963 | DePuy Synthes Craniomaxillofacial Sternal Devices - MR Condi | Synthes (USA) Products, LLC | 2019-07-23 | 102 | 0 |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019-03-13 | 124 | 0 |
| K183472 | DePuy Synthes Porous Polyethylene Implants and Titanium Wire | Synthes (USA) Products, LLC | 2019-03-13 | 89 | 0 |
| K180541 | DePuy Synthes 2.0 mm Quick Insertion Screws | Synthes USA Products, LLC | 2018-11-21 | 265 | 0 |
| K180213 | Titanium TomoFix Medial High Tibia Plate Anatomical | Synthes (USA) Products, LLC | 2018-10-19 | 267 | 0 |
| K182154 | Depuy Synthes Femoral Neck System | Synthes (USA) Products, LLC | 2018-10-16 | 68 | 0 |
| K180544 | DePuy Synthes Static Staples | Synthes (USA) Products, LLC | 2018-07-24 | 145 | 0 |
| K170818 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017-12-07 | 262 | 0 |
| K172157 | DePuy Synthes Femoral Recon Nail System | Synthes (USA) Products, LLC | 2017-11-14 | 119 | 0 |
| K170802 | TRAUMACEM™ V+ Injectable Bone Cement | Synthes (USA) Products, LLC | 2017-09-28 | 195 | 0 |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017-05-08 | 234 | 0 |
| K170654 | USS System | Synthes USA Products, LLC | 2017-03-29 | 26 | 0 |
| K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes | Synthes USA Products, LLC | 2017-02-16 | 248 | 0 |
| K153587 | Taps for Resorbable Screws | Synthes (USA) Products, LLC | 2017-01-18 | 399 | 0 |
| K161590 | MatrixRIB Fixation System | Synthes (USA) Products, LLC | 2016-11-03 | 147 | 0 |
| K162358 | T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Ev | Synthes USA Products, LLC | 2016-11-01 | 70 | 0 |
| K160167 | DePuy Synthes TFNA Augmentation System | Synthes (USA) Products, LLC | 2016-09-26 | 243 | 2 |
| K150673 | SYNFIX Evolution Secured Spacer System | Synthes (USA) Products, LLC | 2015-08-21 | 158 | 0 |
| K150796 | Dental Bone Cutting Instruments | Synthes (USA) Products, LLC | 2015-06-23 | 89 | 0 |
| K151276 | DePuy Synthes T-PAL Ti Spacer | Synthes USA Products, LLC | 2015-06-18 | 36 | 0 |
| K143285 | Mandible External Fixator - MR Conditional | Synthes USA Products, LLC | 2015-05-28 | 192 | 0 |
| K150099 | Depuy Synthes Variable Angle Locking Hand System (1.3 mm and | Synthes (USA) Products, LLC | 2015-03-23 | 62 | 0 |
| K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015-01-20 | 112 | 0 |
| K141165 | MATRIXWAVE MMF SYSTEM | Synthes (USA) Products, LLC | 2014-10-17 | 164 | 0 |
| K141897 | SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM | Synthes USA Products, LLC | 2014-09-25 | 73 | 0 |
| K141796 | DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM | Synthes (USA) Products, LLC | 2014-08-29 | 57 | 0 |
| K130720 | SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM | Synthes (USA) Products, LLC | 2014-08-14 | 514 | 0 |
| K141241 | MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM | Synthes (USA) Products, LLC | 2014-08-07 | 86 | 0 |
| K140462 | MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL | Synthes (USA) Products, LLC | 2014-06-13 | 109 | 0 |
| K133616 | MATRIXRIB FIXATION SYSTEM | Synthes (USA) Products, LLC | 2014-05-02 | 158 | 0 |
| K131548 | SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM | Synthes (USA) Products, LLC | 2014-02-28 | 274 | 9 |
| K133698 | SYNAPSE SYSTEM | Synthes USA Products, LLC | 2014-01-16 | 44 | 0 |
| K131276 | LATERAL SYNFIX | Synthes (USA) Products, LLC | 2014-01-06 | 245 | 0 |
| K132910 | DEPUY SYNTHES SPINE DENS ACCESS SYSTEM | Synthes USA Products, LLC | 2013-12-16 | 90 | 0 |
| K131186 | SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT | Synthes (USA) Products, LLC | 2013-10-08 | 166 | 0 |
| K122639 | SYNTHES SYNCAGE EVOLUTION SPACER | Synthes (USA) Products, LLC | 2013-05-24 | 268 | 0 |
| K123180 | FALCON SPACER | Synthes (USA) Products, LLC | 2013-01-08 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda