# K041889: Tri-Ostetic

- Pathway: 510(k) (Special)
- Applicant: Berkeley Advanced Biomaterials, Inc.
- Decided: Aug 19, 2004 after 38 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) Cem-Ostetic: named in the summary without a submission number

## Indications for use
Tri-Ostetic is an osteoconductive putty that is intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The putty may be shaped and pressed into the void by hand or inserted into a syringe and injected into the surgical site. The Tri-Ostetic paste set in situ or ex situ provides a void filler that can augment hardware to support bone fragments during the surgical procedure. The set putty acts as a temporary support medium and is not intended to provide structural support during the healing process. The implant is radio-opaque. Tri-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

Source page: https://510kreport.com/device/K041889
Methodology: https://510kreport.com/methodology