Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GXP — Predicate Candidate Screening
45 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
323 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251959 | TnR Cranial Implant | T&R BIOFAB CO., Ltd. | 2026-07-30 | 399 | 0 |
| K261265 | Permatage XT Settable Bone Putty | Orthocon, Inc. | 2026-06-15 | 60 | 0 |
| K253732 | Permatage Flowable, Settable Bone Paste | Orthocon, Inc. | 2026-03-13 | 109 | 0 |
| K253854 | MONTAGE XT Cranial Cement | Orthocon, Inc. | 2026-01-02 | 30 | 0 |
| K241027 | Permatage Settable Bone Putty | Orthocon, Inc. | 2024-09-26 | 164 | 0 |
| K232771 | Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. | 2024-02-16 | 158 | 0 |
| K231475 | MONTAGE-QS Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023-10-12 | 143 | 0 |
| K221933 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023-01-13 | 196 | 0 |
| K182742 | DB-CMF | Dimensional Bioceramics, LLC | 2019-06-20 | 265 | 0 |
| K162864 | OsteoVation Impact | Skeletal Kinetics, LLC | 2017-01-13 | 92 | 0 |
| K143661 | DirectInject | Stryker | 2015-09-02 | 253 | 0 |
| K102018 | NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY | Synthes USA Products, LLC | 2010-09-23 | 66 | 0 |
| K091382 | KRYPTONITE BONE CEMENT | Doctors Research Group, Inc. | 2009-11-16 | 189 | 1 |
| K070012 | POLYBONE | Kyung Won Medical Co., Ltd. | 2007-12-27 | 358 | 0 |
| K072601 | OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT | Osteosymbionics, LLC | 2007-12-10 | 87 | 0 |
| K071791 | MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 | Codman & Shurtleff, Inc. | 2007-07-30 | 28 | 0 |
| K060763 | STRYKER INJECTABLE CEMENT | Stryker | 2006-09-22 | 185 | 1 |
| K060443 | NORIAN CRS FAST SET PUTTY | Synthes (Usa) | 2006-04-13 | 51 | 0 |
| K060445 | NORIAN CRS BONE CEMENT | Synthes (Usa) | 2006-04-13 | 51 | 1 |
| K051093 | OSTEOPORE PCL SCAFFOLD | Osteopore, Inc. | 2006-03-17 | 323 | 1 |
| K051784 | OSTEOVATION CMF BONE VOID FILLER | Skeletal Kinetics, LLC | 2005-07-20 | 19 | 5 |
| K043334 | BONE SOURCE HAC RAPID SETTING CEMENT | Stryker Instruments | 2005-02-09 | 68 | 0 |
| K042414 | VISIOPLAST ACRYLIC RESIN | Tecres | 2004-12-29 | 113 | 0 |
| K043280 | MIMIX MP BONE VOID FILLER | Biomet, Inc. | 2004-12-21 | 25 | 0 |
| K042072 | CALLOS CMF BONE VOID FILLER | Skeletal Kinetics, LLC | 2004-09-16 | 45 | 0 |
| K041350 | SYNTHES (USA) CHRONOS | Synthes (Usa) | 2004-07-08 | 49 | 0 |
| K040152 | BONE CEMENT FOR CRANIOPLASTY | Cardinalhealth | 2004-05-19 | 117 | 0 |
| K032366 | BONESOURCE HAC FAST SETTING CEMENT | Stryker Instruments | 2003-10-30 | 90 | 0 |
| K032307 | CAP BONE SUBSTITUTE MATERIAL | Etex Corp. | 2003-10-24 | 91 | 0 |
| K011399 | BIOMET CRANIOFACIAL ACRYLIC CEMENT | Biomet, Inc. | 2003-05-05 | 728 | 0 |
| K023575 | CONCERT CRANIOPLAST | Immedica, Inc. | 2003-01-22 | 90 | 0 |
| K023718 | QUICKSET MIMIX BONE VOID FILLER | Walter Lorenz Surgical, Inc. | 2002-12-04 | 29 | 0 |
| K021440 | BONESOURCE HAC | Stryker Instruments | 2002-08-02 | 88 | 0 |
| K012589 | FAST SET PUTTY | Synthes (Usa) | 2002-02-07 | 181 | 0 |
| K011736 | DRG QUICKMIX | Doctor'S Research Group, Inc. | 2002-01-30 | 239 | 0 |
| K012569 | MODIFICATION TO: INJECTABLE MIMIX | Biomet, Inc. | 2001-12-21 | 134 | 0 |
| K994022 | PARALLAX CRANIOSET | Parallax Medical, Inc. | 2000-08-31 | 279 | 0 |
| K990290 | CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER | Biomet, Inc. | 1999-11-18 | 293 | 0 |
| K991398 | BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT | Stryker Leibinger | 1999-09-22 | 153 | 0 |
| K983009 | BSM- BONE SUBSTITUTE MATERIAL | Etex Corp. | 1998-11-25 | 89 | 0 |
| K982040 | MEDPOR SURGICAL GRANULE IMPLANTS | Porex Surgical, Inc. | 1998-09-08 | 90 | 0 |
| K973789 | NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORI | Norian Corp. | 1998-05-18 | 224 | 0 |
| K964537 | BONESOURCE HYDROXYAPATITE CEMENT (HAC) | Osteogenics, Inc. | 1997-01-24 | 73 | 0 |
| K953339 | BONESOURCE HYDROXYAPATITE CEMENT (HAC) | Osteogenics, Inc. | 1996-06-27 | 346 | 0 |
| K873689 | CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL | Dentsply Intl. | 1987-10-26 | 45 | 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