# K121953: Hemasorb Apply

- Pathway: 510(k) (Special)
- Applicant: Orthocon, Inc.
- Decided: Nov 21, 2012 after 141 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: 11 generations back to K791495 (1979). 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)
- K102762: Orthostat Bone Hemostat Matrix Applicator, Orthocon, Inc. (2011)
- K111575: Hemasorb Absorbable Bone Hemostat Matrix, Orthocon, Inc. (2012)
- K113627: Hemasorb Resorbable Hemostatic Bone Putty, Orthocon (2012)

## Indications for use
Hemasorb Resorbable Hemostatic Bone Putty Applicator 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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following stemnotomy.

Source page: https://510kreport.com/device/K121953
Methodology: https://510kreport.com/methodology