# K071876: Cross.Bone

- Pathway: 510(k) (Traditional)
- Applicant: TriMed, Inc.
- Decided: Dec 17, 2007 after 164 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: 8 generations back to K873689 (1987). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032268: MBCP, Biomatlante (2003) Summary page 2.
- K051774: MBCP, Biomatlante (2006) Summary page 2.
- K060061: Stryker Injectable Cement, Stryker Corp. (2006) Summary page 2.

## Indications for use
Cross.Bone Blocks - CROSS.BONE BLOCK is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary. - Filling losses of bone material resulting from a fracture. - Filling losses of bone material after the resection of benign tumors or cysts Cross.Bone Bottles - CROSS.BONE BOTTLE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary. Filling losses of bone material resulting from a fracture. - Filling losses of bone material after the resection of benign tumors or cysts. Cross.Bone Syringe -CROSS.BONE SYRINGE is recommended for bone reconstructive surgery or as a bone filler following loss of uninfected bone substance of artificial or degenerative origin, suitably reduced, fixed and stabilized where necessary. Bone filler following a fracture, - Bone filler following resection of benign tumors or cysts, When the cavity to be filled is large, it is recommended to cover it with a resorbable membrane. Cross.Bone Wedge -CROSS.BONE WEDGE is recommended for tibial osteotomy with internal fixation, and necessarily in combination with an osteosynthesis procedure (metallic plates and screws).

Source page: https://510kreport.com/device/K071876
Methodology: https://510kreport.com/methodology