# K142348: OsteoSeal Bone Hemostat

- Pathway: 510(k) (Traditional)
- Applicant: Hemostasis, LLC
- Decided: Jan 23, 2015 after 154 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: 9 generations back to K791495 (1979). 22 ancestors in all.
No later device cites it as a predicate yet.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111538: Skaffold Cis, Skeletal Kinetics, LLC (2011) Summary page 6.
- K113079: Synthes Hemostatic Bone Putty, Synthes (Usa) Products, LLC/Norian Corporation (2011) Summary page 6.
- K091121: Orthostat, Orthocon, Inc. (2009) Summary page 6.
- K102762: Orthostat Bone Hemostat Matrix Applicator, Orthocon, Inc. (2011) Summary page 6.
- (no number) Ethicon Bone Wax Preamendment: named in the summary without a submission number

## Indications for use
OsteoSeal® Bone Hemostat is indicated for use in the control of bleeding from cut or damaged bone surfaces by acting as a mechanical barrier. The material may be used during surgical procedures or in treating traumatic injuries. OsteoSeal® Bone Hemostat is intended for use under the direction of a licensed healthcare provider.

Source page: https://510kreport.com/device/K142348
Methodology: https://510kreport.com/methodology