Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GXR — Predicate Candidate Screening
29 FDA 510(k) clearances under this product code; the 50 most recent screened below.
130 daysmedian FDA review time
295 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole | Orthocon, Inc. | 2026-03-16 | 165 | 0 |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bon | Neos Surgery S.L | 2024-02-16 | 29 | 0 |
| K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | 2023-11-21 | 537 | 0 |
| K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | 2020-06-03 | 282 | 0 |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Bu | Neurovention, LLC | 2020-03-13 | 217 | 0 |
| K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018-10-12 | 123 | 0 |
| K181382 | GuardianTM Burr Hole Cover System | St Jude Medical | 2018-07-20 | 56 | 0 |
| K160739 | Cranial COVER | Neos Surgery S.L | 2016-06-12 | 87 | 0 |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole C | St Jude Medical | 2016-06-09 | 295 | 0 |
| K140309 | CRANIOPLUG | Ossdsign AB | 2014-10-03 | 238 | 0 |
| K141368 | NEUROPACE BURR HOLE COVER | NeuroPace, Inc. | 2014-07-11 | 49 | 0 |
| K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL | Neos Surgery S.L | 2013-09-30 | 90 | 0 |
| K123633 | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) | Tissue Regeneration Systems, Inc. | 2013-08-16 | 266 | 0 |
| K130309 | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | Biomet Microfixation | 2013-06-17 | 130 | 0 |
| K123163 | NEUROPACE BURR HOLE COVER MODEL 8110 | NeuroPace, Inc. | 2013-01-18 | 101 | 0 |
| K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | 2010-10-25 | 175 | 0 |
| K091692 | AESCULAP PEEK CRANIOFIX | Aesculap, Inc. | 2010-08-12 | 428 | 0 |
| K071138 | CRANIOCLAMP BIOABSORBABLE CRANIAL BONE FLAP FIXATION SYSTEM | Prosurg, Inc. | 2007-08-15 | 152 | 0 |
| K042986 | MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SY | Synthes (Usa) | 2004-11-17 | 19 | 0 |
| K041611 | SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP | Synthes (Usa) | 2004-09-08 | 85 | 0 |
| K040080 | AESCULAP ABSORBABLE CRANIOFIX | Aesculap, Inc. | 2004-03-31 | 76 | 0 |
| K031654 | SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) | Synthes (Usa) | 2003-08-08 | 72 | 0 |
| K021408 | RESORBABLE CRANIAL CLAMPS | Synthes (Usa) | 2002-07-29 | 87 | 0 |
| K010361 | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 6 | Medtronic PS Medical | 2001-05-07 | 90 | 0 |
| K002334 | MACROPORENS CRANILOC | Macropore Biosurgery, Inc. | 2001-05-02 | 274 | 0 |
| K001096 | BURR HOLE COVER, MODEL XX | Image-Guided Neurologics, Inc. | 2000-10-25 | 204 | 0 |
| K960656 | GORE BURR HOLE COVER | W. L. Gore & Associates, Inc. | 1996-08-14 | 181 | 0 |
| K913490 | PHOENIX BURR HOLE BUTTON, BURR 1 | Phoenix Bioengineering, Inc. | 1992-01-13 | 160 | 0 |
| K853367 | H-H BURR HOLE CATHETER SUPPORT | Holter-Hausner Intl. | 1985-09-11 | 21 | 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