# K071121: Tribone 80

- Pathway: 510(k) (Traditional)
- Applicant: Biomatlante
- Decided: Sep 11, 2007 after 144 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 K963587 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040514: Eovia Calcium Phosphate Ceramic, Ortho Tec, LLC (2004) Summary page 1.
- K033258: Bonesave Bone Void Filler, Howmedica Osteonics (2004) Summary page 1.

## Indications for use
TRIBONE 8OTM is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. TRIBONE 8OTM is a bone filler without initial mechanical properties. Therefore rigid fixation techniques may often be recommended. When packed into a bony site, TRIBONE 8OTM gradually resorbs and is replaced with bone during the healing process. TRIBONE 8 0 TM is to be used in association with adequate post-operative immobilization. TRIBONE 80 TM is provided sterile for single patient use.

Source page: https://510kreport.com/device/K071121
Methodology: https://510kreport.com/methodology