Product Code: MTJ FDA unclassified

Wax, Bone

Unknown

Bone Wax is a sterile waxy substance, typically made from beeswax, applied to cut bone surfaces during surgery to mechanically control bleeding from bone by acting as a hemostatic barrier. This device has an unclassified status (class "U") in the FDA database, meaning it has been through the classification process but remains unclassified. The product code is MTJ, and the device is classified as an implant due to its intraoperative contact with bone tissue.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MTJ
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: OR
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261439	Permatage Flowable, Settable Hemostatic Bone Paste	Jun 03, 2026	Substantially Equivalent	Orthocon, Inc.
K232998	Montage- XT Settable, Resorbable Hemostatic Bone Putty	Oct 12, 2023	Substantially Equivalent	Orthocon, Inc.
K213418	MONTAGE Settable, Resorbable Hemostatic Bone Putty	Aug 30, 2023	Substantially Equivalent	Orthocon, Inc.
K231386	Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste	Jul 11, 2023	Substantially Equivalent	Orthocon, Inc.
K200452	Meril-Bonewax	Mar 27, 2023	Substantially Equivalent	M/s. Meril Endo Surgery Private Limited.
K220315	MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty	Mar 11, 2022	Substantially Equivalent	Orthocon, Inc.
K202363	HBP7 Settable Hemostatic Bone Putty	Jan 19, 2021	Substantially Equivalent	Orthocon, Inc.
K193052	HBP6 Settable, Resorbable Hemostatic Bone Paste	Mar 27, 2020	Substantially Equivalent	Orthocon, Inc.
K191140	MONTAGE-QS Settable, Resorbable Hemostatic Bone	Jul 18, 2019	Substantially Equivalent	Orthocon, Inc.
K153317	HEMASORBPLUS Resorbable Hemostatic Bone Putty	Nov 30, 2016	Substantially Equivalent	Orthocon, Inc.
K153095	ROP Resorbable Hemostasis Material	Feb 17, 2016	Substantially Equivalent	Resorbable Orthopedic Products, LLC
K152005	MONTAGE Settable, Resorbable Hemostatic Bone Putty	Oct 15, 2015	Substantially Equivalent	Orthocon, Inc.
K142348	OsteoSeal Bone Hemostat	Jan 23, 2015	Substantially Equivalent	Hemostasis, LLC
K143069	HEMASORBPLUS press Resorable Hemostatic Bone Putty	Dec 22, 2014	Substantially Equivalent	Orthocon, Inc.
K141502	HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY	Oct 03, 2014	Substantially Equivalent	Orthocon, Inc.
K142339	HEMASORB Resorbable Hemostatic Bone Putty	Sep 26, 2014	Substantially Equivalent	Orthocon, LLC
K140117	AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY	Feb 11, 2014	Substantially Equivalent	Orthocon, Inc.
K123243	HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY	Apr 05, 2013	Substantially Equivalent	Orthocon, Inc.
K122156	ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY	Jan 28, 2013	Substantially Equivalent	Orthocon, Inc.
K121953	HEMASORB APPLY	Nov 21, 2012	Substantially Equivalent	Orthocon, Inc.
K111575	HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX	May 23, 2012	Substantially Equivalent	Orthocon, Inc.
K113627	HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY	Feb 17, 2012	Substantially Equivalent	Orthocon
K113079	SYNTHES HEMOSTATIC BONE PUTTY	Dec 13, 2011	Substantially Equivalent	Synthes (Usa) Products, LLC/Norian Corporation
K111538	SKAFFOLD CIS	Oct 25, 2011	Substantially Equivalent	Skeletal Kinetics, LLC
K111524	MP 719	Jul 22, 2011	Substantially Equivalent	Marine Polymer Technologies, Inc.
K103822	SYNTHES HEMOSTATIC BONE PUTTY (HBP)	May 19, 2011	Substantially Equivalent	Synthes USA Products, LLC
K102762	ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR	Feb 15, 2011	Substantially Equivalent	Orthocon, Inc.
K102071	OSTENE CT, AOC CT, OSTEOTENE, CERETENE	Oct 08, 2010	Substantially Equivalent	Ceremed , Inc.
K091636	OSTENE CT, AOC CT, OSTEOTENE, CERETENE	Jun 22, 2009	Substantially Equivalent	Ceremed , Inc.
K091121	ORTHOSTAT	Apr 28, 2009	Substantially Equivalent	Orthocon, Inc.
K082491	OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE	Sep 24, 2008	Substantially Equivalent	Ceremed , Inc.
K063330	ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY	Nov 22, 2006	Substantially Equivalent	Orthocon, Inc.
K060987	OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31	Nov 02, 2006	Substantially Equivalent	Cp Medical
K052528	AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE	Oct 11, 2005	Substantially Equivalent	Ceremed , Inc.
K043260	ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY	Aug 12, 2005	Substantially Equivalent	Orthocon, LLC
K050440	AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12	Mar 24, 2005	Substantially Equivalent	Ceremed , Inc.
K050292	SHARPOINT LUKENS BONE WAX	Mar 09, 2005	Substantially Equivalent	Surgical Specialties Corp
K041363	AOC BONE WAX	Jul 27, 2004	Substantially Equivalent	Ceremed , Inc.
K024372	CP MEDICAL BONE WAX	Jun 19, 2003	Substantially Equivalent	Cp Medical
K000021	AESCULAP BONE WAX	Mar 24, 2000	Substantially Equivalent	Aesculap, Inc.
K971680	AUTO SUTURE BONE WAX	Oct 24, 1997	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K791495	LUKENS BONE WAX (GAMMA RADIATION)	Sep 24, 1979	Substantially Equivalent	Lukens Corp.