# K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen

- Pathway: 510(k) (Special)
- Applicant: Etex Corp.
- Decided: Jul 1, 2010 after 27 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K960978 (1996). 38 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072355: Ossifuse Bone Substitute Material, Etex Corp. (2007) Summary page 1.
- K072636: A-BSM Bone Substitute Material, Etex Corp. (2007) Summary page 3.
- K033138: CAP3 Bone Substitute Material, Etex Corp. (2003) Summary page 3.
- K093447: Carrigen, Etex Corp. (2010) Summary page 5.
- K090855: Equivabone Osteoinductive Bone Graft Substitute, Etex Corp. (2009) Summary page 7.

## Most influential descendants
- K102528: N-Force Fixation System (2011), 5 descendants of its own
- K132244: N-Force Fixation System (2014), 3 descendants of its own
- K182107: CarriGen PF (2018), 1 descendant of its own
- K151146: N-Force Fixation System (2015), 1 descendant of its own
- K142776: Flow-Screw (2015), 1 descendant of its own

## Indications for use
Beta-bsm Injectable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Beta-bsm Injectable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process. Gamma-bsm Moldable Bone Substitute Material is an implantable bone graft that is a synthetic calcium phosphate, poorly crystalline hydroxyapatite material intended for use in filling bone voids or defects of the skeletal system (i.e. the extremities, posterolateral spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Gamma-bsm Moldable Bone Substitute Material is a bone graft substitute that resorbs and is replaced with new bone during the healing process. CarriGen Porous Bone Substitute Material is an injectable, self setting, macro-porous, osteo-conductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine), and the pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. CarriGen is a bone graft substitute that resorbs and is replaced with new bone during the healing process. EquivaBone is a bone graft substitute that combines synthetic calcium phosphate and demineralized bone. It is resorbed and replaced with new bone during the healing process. It is intended for use to fill bony voids or gaps of the skeletal system of the extremities, spine (i.e. posterolateral spine) and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Source page: https://510kreport.com/device/K101557
Methodology: https://510kreport.com/methodology