# K060750: Stryker Injectable Cement

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Cmf
- Decided: Apr 19, 2006 after 29 days
- Product code: NEA (Cement, Ear, Nose And Throat)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K873689 (1987). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060061: Stryker Injectable Cement, Stryker Corp. (2006) Summary page 2.
- K043334: Bone Source Hac Rapid Setting Cement, Stryker Instruments (2005) Summary page 1.
- K042516: Otomimix, Walter Lorenz Surgical, Inc. (2004) Summary page 1.

## Indications for use
Stryker® Injectable Cement is indicated for use in the following: augmentation or coupling of the middle ear ossicles, attachment of the middle ear ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and the reconstruction of the posterior canal wall.

Source page: https://510kreport.com/device/K060750
Methodology: https://510kreport.com/methodology