# K102071: Ostene CT, Aoc CT, Osteotene, Ceretene

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Oct 8, 2010 after 77 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). 14 ancestors in all.
17 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091636: Ostene CT, Aoc CT, Osteotene, Ceretene, Ceremed, Inc. (2009) Summary page 1.

## Most influential descendants
- K141502: HBP4 Hardening, Resorbable Hemostatic Bone Putty (2014), 13 descendants of its own
- K152005: MONTAGE Settable, Resorbable Hemostatic Bone Putty (2015), 12 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
- K191140: MONTAGE-QS Settable, Resorbable Hemostatic Bone (2019), 3 descendants of its own

## Indications for use
OSTENE'CI' is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces in cardiothoracic surgery surgery following sternotorny.

Source page: https://510kreport.com/device/K102071
Methodology: https://510kreport.com/methodology