# K091121: Orthostat

- Pathway: 510(k) (Special)
- Applicant: Orthocon, Inc.
- Decided: Apr 28, 2009 after 11 days
- Product code: MTJ (Wax, Bone)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K791495 (1979). 8 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043260: Orthocon LLC Orthostat Hemostatic Bone Putty, Orthocon, LLC (2005) Summary page 1.

## Most influential descendants
- K102762: Orthostat Bone Hemostat Matrix Applicator (2011), 9 descendants of its own
- K111575: Hemasorb Absorbable Bone Hemostat Matrix (2012), 6 descendants of its own
- K213418: MONTAGE Settable, Resorbable Hemostatic Bone Putty (2023), 3 descendants of its own
- K242050: Montage Settable Bone Putty (2024), 1 descendant of its own
- K232998: Montage- XT Settable, Resorbable Hemostatic Bone Putty (2023), 1 descendant of its own

## Indications for use
Orthocon OrthostatTM Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.

Source page: https://510kreport.com/device/K091121
Methodology: https://510kreport.com/methodology