# K041177: Synthacer; Syntricer

- Pathway: 510(k) (Traditional)
- Applicant: Medartis Medizinprodukte Und Forschung AG
- Decided: Jun 23, 2005 after 414 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Pore-Si Bone Graft Substitute: named in the summary without a submission number
- (no number) Apapore Bone Graft Substitute: named in the summary without a submission number
- (no number) VitoSS Scaffold Synthetic Cancellous Bone Void Filler: named in the summary without a submission number

## Indications for use
Synthacer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gaps in bone that are not intrins;c to the stability of the bony structure. Synthacer®is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury. Syntricer® Calcium Salt Bone Void Filler is intended only for use as a bone void filler for voids or gags in bone that are not intrinsic to the stability of the bony structure. Syntricer is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury.

Source page: https://510kreport.com/device/K041177
Methodology: https://510kreport.com/methodology