MBP · Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Orthopedic · 21 CFR 888.3045 · Class 2
Overview
| Product Code | MBP |
|---|---|
| Device Name | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) |
| Regulation | 21 CFR 888.3045 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
Cleared Devices (31)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242799 | PliaFX Flo | Lifenet Health | Nov 21, 2024 | SESE |
| K143547 | Vivorte Trabexus EB | Vivorte, Inc. | Jan 14, 2015 | SESE |
| K130703 | VIVORTE BVF | Vivorte, Inc. | Sep 12, 2013 | SESE |
| K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | Bacterin International, Inc. | May 31, 2013 | SESE |
| K122513 | CLEARED UNDER GRAFTON II EDBM | Medtronic Sofamor Danek, Inc. | Mar 6, 2013 | SESE |
| K113728 | SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY | Hans Biomed Corp. | Nov 15, 2012 | SESE |
| K103742 | ACCELL EVO3 (FORMERLY ACCELL A2I) | Integra Life Sciences | Mar 17, 2011 | SESE |
| K091193 | ACCELL EVO3C | Isotis Orthobiologics, Inc. | Aug 10, 2009 | SESE |
| K080399 | DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE | Musculoskeletal Transplant Foundation | Oct 10, 2008 | SESE |
| K081817 | ACCELL TBM-R | Isotis Orthobiologics, Inc. | Sep 24, 2008 | SESE |
| K080405 | SYGNAL DBM | Musculoskeletal Transplant Foundation | Aug 28, 2008 | SESE |
| K080329 | CAP PLUS, EQUIVABONE, CAP/DBM | Etex Corp. | Apr 28, 2008 | SESE |
| K073329 | SYGNAL DBM | Musculoskeletal Transplant Foundation | Feb 28, 2008 | SESE |
| K063685 | OPTECURE; OPTECURE + CCC | Exactech, Inc. | Jun 7, 2007 | SESE |
| K063676 | DBX DEMINERALIZED BONE MATRIX MIX | Musculoskeletal Transplant Foundation | Mar 5, 2007 | SESE |
| K061131 | DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY | Orthocon, Inc. | Feb 8, 2007 | SESE |
| K061982 | PLEXUR P | Osteotech, Inc. | Feb 7, 2007 | SESE |
| K062205 | DBX STRIP | Musculoskeletal Transplant Foundation | Feb 5, 2007 | SESE |
| K060794 | PROGENIX DBM PUTTY AND PASTE | Medtronic Sofamor Danek | Dec 18, 2006 | SESE |
| K061668 | OPTECURE +CCC | Exactech, Inc. | Sep 12, 2006 | SESE |
| K060180 | BIOSET XC | Regeneration Technologies, Inc. | Sep 6, 2006 | SESE |
| K060161 | AFT ALLOGRAFT FILLER TUBE | Musculoskeletal Transplant Foundation | Mar 21, 2006 | SESE |
| K050806 | OPTECURE | Exactech, Inc. | Feb 8, 2006 | SESE |
| K053642 | OSTEOSET DBM PELLETS | Wrightmedicaltechnologyinc | Jan 26, 2006 | SESE |
| K042829 | DBX STRIP | Musculoskeletal Transplant Foundation | Jan 13, 2006 | SESE |
| K052735 | ALLOCRAFT DBM | Lifecell Corp. | Dec 28, 2005 | SESE |
| K051195 | GRAFTON DBM | Osteotech, Inc. | Dec 16, 2005 | SESE |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | Isotis Orthobiologics, Inc. | Dec 5, 2005 | SESE |
| K043209 | VIAGRAF DBM PASTE | Osteotech, Inc. | Dec 5, 2005 | SESE |
| K053098 | OPTIUM DBM GEL AND PUTTY | Lifenet | Nov 28, 2005 | SESE |
| K043048 | GRAFTON PLUS DBM PASTE | Osteotech, Inc. | Nov 23, 2005 | SESE |
Top Applicants
- Musculoskeletal Transplant Foundation — 7 clearances
- Osteotech, Inc. — 4 clearances
- Isotis Orthobiologics, Inc. — 3 clearances
- Exactech, Inc. — 3 clearances
- Vivorte, Inc. — 2 clearances
