Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MTJ — Predicate Candidate Screening
42 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
261 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261439 | Permatage Flowable, Settable Hemostatic Bone Paste | Orthocon, Inc. | 2026-06-03 | 34 | 0 |
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023-10-12 | 20 | 0 |
| K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023-08-30 | 679 | 0 |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Pa | Orthocon, Inc. | 2023-07-11 | 60 | 0 |
| K200452 | Meril-Bonewax | M/s. Meril Endo Surgery Private Limited. | 2023-03-27 | 1127 | 0 |
| K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2022-03-11 | 36 | 0 |
| K202363 | HBP7 Settable Hemostatic Bone Putty | Orthocon, Inc. | 2021-01-19 | 153 | 0 |
| K193052 | HBP6 Settable, Resorbable Hemostatic Bone Paste | Orthocon, Inc. | 2020-03-27 | 147 | 0 |
| K191140 | MONTAGE-QS Settable, Resorbable Hemostatic Bone | Orthocon, Inc. | 2019-07-18 | 79 | 0 |
| K153317 | HEMASORBPLUS Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2016-11-30 | 378 | 0 |
| K153095 | ROP Resorbable Hemostasis Material | Resorbable Orthopedic Products, LLC | 2016-02-17 | 114 | 0 |
| K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2015-10-15 | 87 | 0 |
| K142348 | OsteoSeal Bone Hemostat | Hemostasis, LLC | 2015-01-23 | 154 | 0 |
| K143069 | HEMASORBPLUS press Resorable Hemostatic Bone Putty | Orthocon, Inc. | 2014-12-22 | 56 | 0 |
| K141502 | HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2014-10-03 | 119 | 0 |
| K142339 | HEMASORB Resorbable Hemostatic Bone Putty | Orthocon, LLC | 2014-09-26 | 36 | 0 |
| K140117 | AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2014-02-11 | 26 | 0 |
| K123243 | HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2013-04-05 | 170 | 0 |
| K122156 | ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2013-01-28 | 192 | 0 |
| K121953 | HEMASORB APPLY | Orthocon, Inc. | 2012-11-21 | 141 | 0 |
| K111575 | HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX | Orthocon, Inc. | 2012-05-23 | 352 | 0 |
| K113627 | HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY | Orthocon | 2012-02-17 | 71 | 0 |
| K113079 | SYNTHES HEMOSTATIC BONE PUTTY | Synthes (Usa) Products, LLC/Norian Corporation | 2011-12-13 | 57 | 2 |
| K111538 | SKAFFOLD CIS | Skeletal Kinetics, LLC | 2011-10-25 | 145 | 0 |
| K111524 | MP 719 | Marine Polymer Technologies, Inc. | 2011-07-22 | 50 | 0 |
| K103822 | SYNTHES HEMOSTATIC BONE PUTTY (HBP) | Synthes USA Products, LLC | 2011-05-19 | 140 | 1 |
| K102762 | ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR | Orthocon, Inc. | 2011-02-15 | 144 | 0 |
| K102071 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | Ceremed , Inc. | 2010-10-08 | 77 | 0 |
| K091636 | OSTENE CT, AOC CT, OSTEOTENE, CERETENE | Ceremed , Inc. | 2009-06-22 | 18 | 0 |
| K091121 | ORTHOSTAT | Orthocon, Inc. | 2009-04-28 | 11 | 0 |
| K082491 | OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, | Ceremed , Inc. | 2008-09-24 | 27 | 0 |
| K063330 | ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2006-11-22 | 19 | 0 |
| K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 | Cp Medical | 2006-11-02 | 206 | 0 |
| K052528 | AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE | Ceremed , Inc. | 2005-10-11 | 27 | 0 |
| K043260 | ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY | Orthocon, LLC | 2005-08-12 | 261 | 0 |
| K050440 | AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERET | Ceremed , Inc. | 2005-03-24 | 30 | 0 |
| K050292 | SHARPOINT LUKENS BONE WAX | Surgical Specialties Corp | 2005-03-09 | 30 | 0 |
| K041363 | AOC BONE WAX | Ceremed , Inc. | 2004-07-27 | 67 | 1 |
| K024372 | CP MEDICAL BONE WAX | Cp Medical | 2003-06-19 | 170 | 0 |
| K000021 | AESCULAP BONE WAX | Aesculap, Inc. | 2000-03-24 | 80 | 0 |
| K971680 | AUTO SUTURE BONE WAX | United States Surgical, A Division of Tyco Healthc | 1997-10-24 | 170 | 0 |
| K791495 | LUKENS BONE WAX (GAMMA RADIATION) | Lukens Corp. | 1979-09-24 | 52 | 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