# K043260: Orthocon LLC Orthostat Hemostatic Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Orthocon, LLC
- Decided: Aug 12, 2005 after 261 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: 3 generations back to K791495 (1979). 7 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024372: CP Medical Bone Wax, Cp Medical (2003) Summary page 1.
- K032930: Ultraflex Esophageal NG Stent System, Boston Scientific Corp (2003) Summary page 2.
- K971680: Auto Suture Bone Wax, United States Surgical, A Division of Tyco Healthc (1997) Summary page 1.
- K041363: Aoc Bone Wax, Ceremed, Inc. (2004) Summary page 1.
- K791495: Lukens Bone Wax (Gamma Radiation), Lukens Corp. (1979) Summary page 2.
- K000021: Aesculap Bone Wax, Aesculap, Inc. (2000) Summary page 2.
- (no number) Ethicon Bone Wax: named in the summary without a submission number

## Most influential descendants
- K091121: Orthostat (2009), 10 descendants of its own
- 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

## Indications for use
The Orthocon OrthoStat TM 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/K043260
Methodology: https://510kreport.com/methodology