Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GWO — Predicate Candidate Screening
43 FDA 510(k) clearances under this product code; the 50 most recent screened below.
148 daysmedian FDA review time
287 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261058 | CraniUS Plate | CraniUS, LLC | 2026-07-29 | 120 | 0 |
| K250297 | TECHFIT Patient-Specific Cranial System | Techfit Digital Surgery, Inc. | 2025-10-27 | 269 | 0 |
| K250334 | Fusion Craniofacial Implant; Fusion Skull Implant | Kelyniam Global, Inc. | 2025-07-25 | 170 | 0 |
| K231834 | VSP PEEK Cranial Implant | 3D Systems, Inc. | 2024-04-04 | 287 | 0 |
| K212391 | MCI-Neuro Fixation System | Mci Medical Concept Innovation, Inc. | 2022-10-21 | 445 | 0 |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A | Osteonic Co., Ltd. | 2022-01-27 | 353 | 0 |
| K203055 | Stryker PEEK Customized Cranial Implant Kit | Stryker | 2021-02-09 | 124 | 0 |
| K190811 | Optimus NEURO System - Sterile Kit | Osteonic Co., Ltd. | 2019-11-27 | 243 | 0 |
| K190229 | Stryker PEEK Customized Cranial Implant Kit | Stryker | 2019-07-11 | 156 | 0 |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Impl | Kelyniam Global, Inc. | 2019-05-21 | 236 | 0 |
| K183352 | Optimus Neuro System | Osteonic Co., Ltd. | 2019-01-02 | 30 | 0 |
| K182425 | Universal Mesh - Sterile | Stryker Leibinger GmbH & Co KG | 2018-11-06 | 61 | 1 |
| K170725 | Stryker Universal Mesh | Stryker | 2017-11-13 | 249 | 0 |
| K170368 | Sterile NS System | Jeil Medical Corporation | 2017-09-11 | 217 | 0 |
| K161821 | Stryker Universal Mesh | Stryker | 2016-12-08 | 160 | 0 |
| K161446 | Biopor Porous Polyethylene Implants | Ceremed , Inc. | 2016-09-27 | 125 | 0 |
| K153248 | PEEK Customized Cranial Implant | Stryker | 2016-03-10 | 122 | 0 |
| K152076 | PEEK Customized Cranial Implant, PEEK Customized Cranial Imp | Stryker | 2015-08-26 | 30 | 0 |
| K141123 | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM | Alliance Partners, LLC | 2015-02-27 | 302 | 0 |
| K141911 | OPTIMUS NEURO SYSTEM | Osteonic Co., Ltd. | 2015-02-10 | 210 | 0 |
| K141644 | INNOVASIS CRANIAL SYSTEM | Innovasis, Inc. | 2014-11-07 | 141 | 0 |
| K141452 | LEFORTE NEURO SYSTEM BONE PLATE AND SCREW | Jeil Medical Corporation | 2014-07-02 | 30 | 0 |
| K140462 | MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL | Synthes (USA) Products, LLC | 2014-06-13 | 109 | 0 |
| K131775 | UNIVERSAL NEURO 3 SYSTEM | Stryker | 2013-10-17 | 122 | 0 |
| K123723 | SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM | Synthes | 2013-09-05 | 275 | 0 |
| K122049 | NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM | Kinamed, Inc. | 2013-04-05 | 267 | 0 |
| K121606 | RESORB-X G | KLS-Martin L.P. | 2013-01-17 | 230 | 0 |
| K121624 | BIOMET MICROFIXATION NEURO PLATING SYSTEM | Biomet Microfixation | 2012-10-12 | 133 | 0 |
| K121153 | PEEK CUSTOMIZED CRAIAL IMPLANT KIT | Stryker | 2012-09-14 | 151 | 0 |
| K120352 | STRYKER QUIKFLAP STERILE PROCEDURE PACK | Stryker | 2012-06-11 | 126 | 0 |
| K112812 | LEFORTE NEURO SYSTEM BONE PLATE | Jeil Medical Corporation | 2012-02-22 | 148 | 0 |
| K112557 | STRYKER UNIVERSAL NEURO 3 SYSTEM | Stryker | 2012-01-05 | 125 | 0 |
| K111176 | OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM | Osteomed LP | 2011-08-15 | 110 | 2 |
| K111065 | STRYKER (R) PATIENT SPECIFIC POLYMER IMPLANT | Howmedica Osteonics Corp. Dba Stryker Orthopeadics | 2011-07-14 | 87 | 0 |
| K100205 | FRONTIER DEVICES NEURO SYSTEM | Folsom Metal Products, Inc. | 2010-12-13 | 322 | 0 |
| K073006 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | Takiron Co., Ltd. | 2008-05-29 | 218 | 0 |
| K072758 | SYNTHES (USA) 2.0MM TITANIUM T-PLATE | Synthes (Usa) | 2007-12-18 | 81 | 0 |
| K974206 | SYNTHES CRANIAL SPRING CLIP (CSC) | Synthes (Usa) | 1998-03-16 | 126 | 0 |
| K903485 | TITANIUM MESH | Ruggles Corp. | 1991-02-21 | 205 | 0 |
| K861884 | NEUROSCOPE SEEG | Siegen Corp. | 1986-10-14 | 152 | 0 |
| K861822 | MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI | Valley Forge Scientific Corp. | 1986-07-11 | 60 | 0 |
| K812951 | RION AUDIOMETER AA-67 | Rion Acoustic Instruments, Inc. | 1981-11-06 | 16 | 0 |
| K812952 | RION AUDIOMETER AA-68 | Rion Acoustic Instruments, Inc. | 1981-11-06 | 16 | 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