# K143692: GranOSTM - beta tricalcium phosphate synthetic bone granules

- Pathway: 510(k) (Traditional)
- Applicant: Tcm Associates, Ltd.
- Decided: Aug 21, 2015 after 240 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: 3 generations back to K013072 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041616: Bgran Synthetic Osteoconductive Scaffoid, Orthos (Uk) Limited (2004) Summary page 5.
- K014156: Cerasorb Ortho, Curasan AG (2002) Summary page 5.
- K032409: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita, Inc. (2003) Summary page 5.

## Indications for use
GranOS™ devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. GranOS™ is indicated to be gently placed into bony voids or gaps of the skeletal system (ie the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K143692
Methodology: https://510kreport.com/methodology