Atlas FDA

MTJ

42 FDA 510(k) clearances · Product code

80 daysmedian time to decision
261 days90th percentile
42clearances measured

FDA profile

Official device name
Wax, Bone
Device class
Unclassified
Medical specialty
Unknown
Flags
Implant
Adverse events (MAUDE)
2020: 16 · 2022: 31 · 2023: 20 · 2024: 32 · 2025: 23 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Permatage Flowable, Settable Hemostatic Bone Paste (K261439)Orthocon, Inc.2026-06-03
Montage- XT Settable, Resorbable Hemostatic Bone Putty (K232998)Orthocon, Inc.2023-10-12
MONTAGE Settable, Resorbable Hemostatic Bone Putty (K213418)Orthocon, Inc.2023-08-30
Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste (K231386)Orthocon, Inc.2023-07-11
Meril-Bonewax (K200452)M/s. Meril Endo Surgery Private Limited.2023-03-27
MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty (K220315)Orthocon, Inc.2022-03-11
HBP7 Settable Hemostatic Bone Putty (K202363)Orthocon, Inc.2021-01-19
HBP6 Settable, Resorbable Hemostatic Bone Paste (K193052)Orthocon, Inc.2020-03-27
MONTAGE-QS Settable, Resorbable Hemostatic Bone (K191140)Orthocon, Inc.2019-07-18
HEMASORBPLUS Resorbable Hemostatic Bone Putty (K153317)Orthocon, Inc.2016-11-30
ROP Resorbable Hemostasis Material (K153095)Resorbable Orthopedic Products, LLC2016-02-17
MONTAGE Settable, Resorbable Hemostatic Bone Putty (K152005)Orthocon, Inc.2015-10-15
OsteoSeal Bone Hemostat (K142348)Hemostasis, LLC2015-01-23
HEMASORBPLUS press Resorable Hemostatic Bone Putty (K143069)Orthocon, Inc.2014-12-22
HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY (K141502)Orthocon, Inc.2014-10-03
HEMASORB Resorbable Hemostatic Bone Putty (K142339)Orthocon, LLC2014-09-26
AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY (K140117)Orthocon, Inc.2014-02-11
HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY (K123243)Orthocon, Inc.2013-04-05
ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY (K122156)Orthocon, Inc.2013-01-28
HEMASORB APPLY (K121953)Orthocon, Inc.2012-11-21
HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX (K111575)Orthocon, Inc.2012-05-23
HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY (K113627)Orthocon2012-02-17
SYNTHES HEMOSTATIC BONE PUTTY (K113079)Synthes (Usa) Products, LLC/Norian Corporation2011-12-13
SKAFFOLD CIS (K111538)Skeletal Kinetics, LLC2011-10-25
MP 719 (K111524)Marine Polymer Technologies, Inc.2011-07-22
SYNTHES HEMOSTATIC BONE PUTTY (HBP) (K103822)Synthes USA Products, LLC2011-05-19
ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR (K102762)Orthocon, Inc.2011-02-15
OSTENE CT, AOC CT, OSTEOTENE, CERETENE (K102071)Ceremed , Inc.2010-10-08
OSTENE CT, AOC CT, OSTEOTENE, CERETENE (K091636)Ceremed , Inc.2009-06-22
ORTHOSTAT (K091121)Orthocon, Inc.2009-04-28
OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE (K082491)Ceremed , Inc.2008-09-24
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY (K063330)Orthocon, Inc.2006-11-22
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 (K060987)Cp Medical2006-11-02
AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE (K052528)Ceremed , Inc.2005-10-11
ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY (K043260)Orthocon, LLC2005-08-12
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 (K050440)Ceremed , Inc.2005-03-24
SHARPOINT LUKENS BONE WAX (K050292)Surgical Specialties Corp2005-03-09
AOC BONE WAX (K041363)Ceremed , Inc.2004-07-27
CP MEDICAL BONE WAX (K024372)Cp Medical2003-06-19
AESCULAP BONE WAX (K000021)Aesculap, Inc.2000-03-24
AUTO SUTURE BONE WAX (K971680)United States Surgical, A Division of Tyco Healthc1997-10-24
LUKENS BONE WAX (GAMMA RADIATION) (K791495)Lukens Corp.1979-09-24

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Every clearance here is in the API, with alerts when new ones post.