# K051775: Osteomimetic Synthetic Bone Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Biomimetic Pharmaceuticals, Inc.
- Decided: Sep 6, 2005 after 67 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: 2 generations back to K990131 (1999). 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)
- K014053: Conduit TCP Granules, Depuyacromed (2002) Summary page 1.
- K013072: Chronos Tricalcium Prosphate (Chronos TCP), Synthes (2002) Summary page 1.
- K994337: Vitoss Scaffold Synthetic Cancellous Bone Void Filler, Orthovita Co. (2000) Summary page 1.

## Indications for use
OsteoMimetic™ Synthetic Bone Matrix is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. The OsteoMimetic matrix is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone in conjunction with standard measures.

Source page: https://510kreport.com/device/K051775
Methodology: https://510kreport.com/methodology