Wax, Bone
FDA product code MTJ · Unclassified · Orthopedic
43510(k) clearances
0PMA approvals
4recalls
Implantimplanted device
Manufacturers
- Orthocon, Inc. 24
- Ceremed , Inc. 6
- Cp Medical 2
- Lukens Corp. 1
- United States Surgical, A Division of Tyco Healthc 1
- Aesculap, Inc. 1
- Surgical Specialties Corp 1
- Synthes (USA) Products LLC 1
- Marine Polymer Technologies, Inc. 1
- Skeletal Kinetics, Llc 1
- Synthes (Usa) Products, LLC/Norian Corporation 1
- Hemostasis, LLC 1
- Resorbable Orthopedic Products, LLC 1
- M/s. Meril Endo Surgery Private Limited. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262769 | Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)MTJ · Special | Orthocon, Inc. | 09/03/2026SE |
| K261439 | Permatage Flowable, Settable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 06/03/2026SE |
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Special | Orthocon, Inc. | 10/12/2023SE |
| K213418 | MONTAGE Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 08/30/2023SE |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 07/11/2023SE |
| K200452 | Meril-BonewaxMTJ · Traditional | M/s. Meril Endo Surgery Private Limited. | 03/27/2023SE |
| K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 03/11/2022SE |
| K202363 | HBP7 Settable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 01/19/2021SE |
| K193052 | HBP6 Settable, Resorbable Hemostatic Bone PasteMTJ · Traditional | Orthocon, Inc. | 03/27/2020SE |
| K191140 | MONTAGE-QS Settable, Resorbable Hemostatic BoneMTJ · Traditional | Orthocon, Inc. | 07/18/2019SE |
| K153317 | HEMASORBPLUS Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 11/30/2016SE |
| K153095 | ROP Resorbable Hemostasis MaterialMTJ · Traditional | Resorbable Orthopedic Products, LLC | 02/17/2016SE |
| K152005 | MONTAGE Settable, Resorbable Hemostatic Bone PuttyMTJ · Special | Orthocon, Inc. | 10/15/2015SE |
| K142348 | OsteoSeal Bone HemostatMTJ · Traditional | Hemostasis, LLC | 01/23/2015SE |
| K143069 | HEMASORBPLUS press Resorable Hemostatic Bone PuttyMTJ · Special | Orthocon, Inc. | 12/22/2014SE |
| K141502 | HBP4 Hardening, Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 10/03/2014SE |
| K142339 | HEMASORB Resorbable Hemostatic Bone PuttyMTJ · Special | Orthocon, LLC | 09/26/2014SE |
| K140117 | Ahbppress Absorbable Hemostatic Bone PuttyMTJ · Special | Orthocon, Inc. | 02/11/2014SE |
| K123243 | Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 04/05/2013SE |
| K122156 | Orthocon Absorbable Hemostatic Bone PuttyMTJ · Traditional | Orthocon, Inc. | 01/28/2013SE |
| K121953 | Hemasorb ApplyMTJ · Special | Orthocon, Inc. | 11/21/2012SE |
| K111575 | Hemasorb Absorbable Bone Hemostat MatrixMTJ · Traditional | Orthocon, Inc. | 05/23/2012SE |
| K113627 | Hemasorb Resorbable Hemostatic Bone PuttyMTJ · Special | Orthocon | 02/17/2012SE |
| K113079 | Synthes Hemostatic Bone PuttyMTJ · Traditional | Synthes (Usa) Products, LLC/Norian Corporation | 12/13/2011SE |
| K111538 | Skaffold CisMTJ · Traditional | Skeletal Kinetics, LLC | 10/25/2011SE |
| K111524 | MP 719MTJ · Traditional | Marine Polymer Technologies, Inc. | 07/22/2011SE |
| K103822 | Synthes Hemostatic Bone Putty (HBP)MTJ · Traditional | Synthes USA Products, LLC | 05/19/2011SE |
| K102762 | Orthostat Bone Hemostat Matrix ApplicatorMTJ · Traditional | Orthocon, Inc. | 02/15/2011SE |
| K102071 | Ostene CT, Aoc CT, Osteotene, CereteneMTJ · Traditional | Ceremed , Inc. | 10/08/2010SE |
| K091636 | Ostene CT, Aoc CT, Osteotene, CereteneMTJ · Special | Ceremed , Inc. | 06/22/2009SE |
| K091121 | OrthostatMTJ · Special | Orthocon, Inc. | 04/28/2009SE |
| K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene &…MTJ · Special | Ceremed , Inc. | 09/24/2008SE |
| K063330 | Orthocon Hemasorb Resorbable Hemostatic Bone PuttyMTJ · Special | Orthocon, Inc. | 11/22/2006SE |
| K060987 | OSCERA7 Synthetic Absorbable Bone Wax, Model OS31MTJ · Traditional | Cp Medical | 11/02/2006SE |
| K052528 | Aoc Bone Wax Ostene, Osteotene and CereteneMTJ · Special | Ceremed , Inc. | 10/11/2005SE |
| K043260 | Orthocon LLC Orthostat Hemostatic Bone PuttyMTJ · Traditional | Orthocon, LLC | 08/12/2005SE |
| K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12MTJ · Special | Ceremed , Inc. | 03/24/2005SE |
| K050292 | Sharpoint Lukens Bone WaxMTJ · Traditional | Surgical Specialties Corp | 03/09/2005SE |
| K041363 | Aoc Bone WaxMTJ · Traditional | Ceremed , Inc. | 07/27/2004SE |
| K024372 | CP Medical Bone WaxMTJ · Traditional | Cp Medical | 06/19/2003SE |
| K000021 | Aesculap Bone WaxMTJ · Traditional | Aesculap, Inc. | 03/24/2000SE |
| K971680 | Auto Suture Bone WaxMTJ · Traditional | United States Surgical, A Division of Tyco Healthc | 10/24/1997SE |
| K791495 | Lukens Bone Wax (Gamma Radiation)MTJ · Traditional | Lukens Corp. | 09/24/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0658-2024 Class II | Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G…Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed… | Baxter Healthcare Corporation | 12/06/2023Open, Classified |
| Z-2206-2012 Class I | Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S…There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems… | Synthes USA HQ, Inc. | 07/05/2012Terminated |
| Z-1094-2015 Class II | Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the…Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision… | Synthes, Inc. | 01/06/2012Terminated |
| Z-0992-2009 | Bone Wax. Ethicon, Inc. Bone wax is available sterile in individual foil envelopes, each…A hospital reported to their Ethicon sales representative that they had an "unmarked" box of bone was on… | Ethicon, Inc. | 10/28/2008Terminated |