Acceli DBM Family Products, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K061880 ↗

FDA Product Code

MQV

Device Class

Class II

Regulation

21 CFR Part 888.3045

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Ossatura Bcp Bone Void Filler

  Class II

  FDA 510(k) K030131 Active Cleared 20 May 2003

• Accell Connexus Demineralized Bone Matrix Putty

  Class II

  FDA 510(k) K060306 Active Cleared 27 Mar 2006

• Orthoblast II Dbm Demineralized Bone Matrix Paste and Putty

  Class II

  FDA 510(k) K060332 Active Cleared 29 Mar 2006

• Ossatura Dental

  Class II

  FDA 510(k) K031813 Active Cleared 20 Aug 2004

• Open Bore Syringe

  Class II

  FDA 510(k) K041344 Active Cleared 16 Jul 2004

• Shuttle Stop

  Class II

  FDA 510(k) K000587 Active Cleared 4 May 2000

See all devices from Isotis NV →

• What orthopedic procedures are these DBM grafts typically used for, and how do they support bone healing?

  The Acceli DBM Family Products are designed to support bone regeneration and integration in orthopedic procedures involving bone defects or reconstructions. They work by providing a scaffold that promotes cellular activity, leveraging the natural properties of demineralized bone matrix (DBM) to enhance the body’s own healing processes. This makes them suitable for applications like spinal fusion, fracture repair, or joint reconstruction where bone growth is critical.

• Are these DBM grafts single-use only, and if so, how should they be stored to maintain sterility?

  Yes, the Acceli DBM Family Products are supplied as single-use items, intended for one-time surgical use only. Sterility is maintained through manufacturer-specified storage and handling protocols, which likely include keeping them in a sealed, sterile packaging until use. Always follow the provided instructions to preserve sterility, as improper storage could compromise their effectiveness.

• What volume options are available for these DBM grafts, and how might a clinician choose the right size for a procedure?

  The Acceli DBM Family Products come in pre-measured volumes ranging from 0.5cc to 30cc, allowing clinicians to select the appropriate size based on the specific bone defect or reconstruction site. The choice depends on factors like the size of the defect, the surgical technique, and the patient’s anatomical requirements. Larger defects may require higher volumes, while smaller areas might use the lower-end options.

• How were these DBM grafts cleared by the FDA, and what does that mean for their regulatory status?

  The Acceli DBM Family Products were cleared via a Traditional 510(k) pathway with a Substantially Equivalent determination by the FDA, effective August 15, 2007. This means the device was found to be similar enough to a legally marketed predicate device to justify its approval without requiring a full premarket approval process. The clearance was filed under product code MQV, which pertains to bone grafts and substitutes.