Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GXN — Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
102 daysmedian FDA review time
345 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Sl | Longeviti Neuro Solutions | 2026-06-25 | 113 | 0 |
| K253116 | 3D MAC Titanium Cranial Plate (TCP) System | The Surgeon General, Department of the Army (TSG-DA) | 2026-06-18 | 267 | 0 |
| K252251 | EASYMADE-TI | CG Bio Co., Ltd. | 2026-04-09 | 265 | 0 |
| K252958 | METICULY Patient-specific titanium mesh implant | Meticuly Co., Ltd. | 2026-01-14 | 120 | 0 |
| K243715 | Synthes Patient Specific Implants | Synthes GmbH | 2025-11-12 | 345 | 0 |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-M | KLS-Martin L.P. | 2025-11-10 | 88 | 0 |
| K240567 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2024-03-28 | 28 | 0 |
| K231920 | Longeviti ClearFit OTS Cranial Implant | Longeviti Neuro Solutions, LLC | 2023-11-09 | 133 | 0 |
| K214109 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | Kontour(Xi’An) Medical Technology Co., Ltd. | 2022-10-28 | 303 | 0 |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | Medcad | 2022-08-26 | 199 | 0 |
| K210099 | Meticuly Patient-Specific Titanium Mesh Implant | Meticuly Co., Ltd. | 2021-12-21 | 341 | 0 |
| K212058 | Longeviti ClearFit™ OTS Cranial Implants | Longeviti Neuro Solutions, LLC | 2021-09-08 | 69 | 0 |
| K210616 | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | 2021-03-31 | 30 | 0 |
| K203349 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020-12-16 | 33 | 0 |
| K202901 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020-10-30 | 31 | 0 |
| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditi | Synthes (USA) Products, LLC | 2020-09-18 | 357 | 0 |
| K193547 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2020-01-17 | 28 | 0 |
| K191210 | Longeviti ClearFit Cranial Implant | Longeviti Neuro Solutions, LLC | 2020-01-09 | 248 | 0 |
| K180064 | OsteoFab Patient Specific Cranial Device | Oxford Performance Materials, Inc. | 2018-07-27 | 199 | 0 |
| K180513 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2018-05-15 | 77 | 0 |
| K170410 | Longeviti PMMA Static Cranial Implant | Longeviti Neuro Solutions, LLC | 2018-03-23 | 406 | 0 |
| K171507 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2017-09-01 | 101 | 0 |
| K161090 | Cranial PSI | Ossdsign AB | 2017-01-19 | 276 | 0 |
| K160707 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2016-12-17 | 278 | 0 |
| K151692 | BioArchitects Patient Specific Cranial/Craniofacial Plate | Bioarchitects USA, LLC | 2015-11-20 | 150 | 0 |
| K151382 | Patient Contoured Implant-PEEK (PCI-PEEK) | KLS Martin L.P. | 2015-11-09 | 171 | 0 |
| K130447 | SPEEDY FLAP SYSTEM | Jeil Medical Corporation | 2014-12-22 | 669 | 0 |
| K133082 | OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE | Osteosymbionics, LLC | 2014-05-20 | 232 | 0 |
| K121818 | OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE | Oxford Performance Materials | 2013-02-07 | 232 | 0 |
| K121755 | CUSTOM CRANIOFACIAL IMPLANT (CCI) | Kelyniam Global, Inc. | 2012-09-25 | 102 | 0 |
| K122353 | CRAINFIX 2 TITANIUM CLAMP SYSTEM | Aesculap, Inc. | 2012-08-30 | 27 | 0 |
| K121102 | OSTEOSYMBIONICS PEEK CRANIAL IMPLANT | Osteosymbionics, LLC | 2012-08-08 | 119 | 0 |
| K110684 | MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIO | Vanduzen Dba Medcad | 2011-06-24 | 105 | 0 |
| K103582 | KELYNIAM CUSTOM SKULL IMPLANT (CSI) | Kelyniam Global, Inc. | 2011-04-14 | 127 | 0 |
| K082175 | MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIO | Bioplate, Inc. | 2008-08-13 | 12 | 0 |
| K072707 | PATIENT CONTOURED MESH-PEEK (PCM-P) | KLS-Martin L.P. | 2007-12-19 | 85 | 0 |
| K070901 | MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION S | Bioplate, Inc. | 2007-06-15 | 74 | 0 |
| K062819 | BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL S | Bioplate, Inc. | 2006-12-04 | 75 | 0 |
| K062857 | KLS MARTIN QUICK DISC | KLS Martin L.P. | 2006-11-22 | 58 | 0 |
| K062570 | PATIENT CONTOURED MESH (PCM) | KLS-Martin L.P. | 2006-10-31 | 61 | 0 |
| K052871 | STRYKER CUSTOM TI IMPLANT | Stryker Leibinger | 2005-12-16 | 66 | 0 |
| K053199 | SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT | Synthes (Usa) | 2005-12-14 | 28 | 0 |
| K033868 | SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS | Synthes (Usa) | 2004-06-21 | 192 | 0 |
| K040864 | CRANIOFIX AND CRANIOFIX2 TITANIUM CLAMP SYSTEM | Aesculap | 2004-06-17 | 76 | 0 |
| K031034 | SPIN DOWN RAPIDFLAP | Walter Lorenz Surgical, Inc. | 2003-05-21 | 50 | 0 |
| K022277 | OSTEOMED CRANIAL FLAP FIXATION SYSTEM | Osteomed Corp. | 2003-04-01 | 260 | 0 |
| K030378 | STRYKER LEIBINGER CRANIAL FIXATION SYSTEM | Stryker Instruments | 2003-03-20 | 43 | 0 |
| K020088 | MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | 2002-02-08 | 29 | 0 |
| K013050 | THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM | Bioplate, Inc. | 2001-12-10 | 90 | 0 |
| K013000 | MEDTRONIC INVISX BURR HOLE LOCK, MODEL 60520 | Medtronic Neurosurgery | 2001-12-05 | 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