# K111538: Skaffold Cis

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Kinetics, LLC
- Decided: Oct 25, 2011 after 145 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: 6 generations back to K791495 (1979). 11 ancestors in all.
18 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971680: Auto Suture Bone Wax, United States Surgical, A Division of Tyco Healthc (1997) Summary page 1.
- K062280: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste, Ceremed, Inc. (2006) Summary page 1.
- K791495: Lukens Bone Wax (Gamma Radiation), Lukens Corp. (1979) Summary page 1.
- (no number) Ethicon Bone Wax: named in the summary without a submission number

## Most influential descendants
- K123243: Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty (2013), 16 descendants of its own
- 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
- 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
CAAP (Calcium Apatite) Bone Wax is indicated to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Source page: https://510kreport.com/device/K111538
Methodology: https://510kreport.com/methodology