# K013966: Apatight-TCP Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Cerabio, LLC
- Decided: May 16, 2002 after 164 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
No predicates in its family tree.
61 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vitoss™ Scaffold Synthetic Cancellous Bone Void Filler: named in the summary without a submission number

## Most influential descendants
- K022629: WMT-TCP Bone Graft Substitute (2002), 58 descendants of its own
- K031817: Cellplex TCP Synthetic Cancellous Bone (2003), 52 descendants of its own
- K043261: Harvest Graft Delivery Syringe (2005), 51 descendants of its own
- K100754: Graft Delivery System Model SA-6115 (2010), 45 descendants of its own
- K111632: Infill Graft Delivery System (2011), 41 descendants of its own

## Indications for use
Apatight-TCP Bone Graft Substitute is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. Apatight-TCP is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K013966
Methodology: https://510kreport.com/methodology