# K042516: Otomimix

- Pathway: 510(k) (Traditional)
- Applicant: Walter Lorenz Surgical, Inc.
- Decided: Nov 8, 2004 after 53 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: 1 generation back to K861369 (1986). 3 ancestors in all.
33 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990290: Craniofacial Calcium Phosphate Ceramic Bone Filler, Biomet, Inc. (1999) Summary page 1.
- K011338: Oto-Cem, Ototech, Inc. (2001)
- K861369: Incus/Stapes Prosthesis, Richards Medical Co., Inc. (1986) Summary page 1.

## Most influential descendants
- K060061: Stryker Injectable Cement (2006), 30 descendants of its own
- K161447: HydroSet XT (2016), 10 descendants of its own
- K060763: Stryker Injectable Cement (2006), 8 descendants of its own
- K173008: SCS 17-01 (2017), 4 descendants of its own
- K222063: MONTAGE Settable, Resorbable Bone Putty (2023), 3 descendants of its own

## Indications for use
OtoMimixTM is indicated for the following: 1. Augmentation or coupling of the middle ear ossicles. 2. Attachment of the middle ear ossicles to middle ear implants. 3. Mechanical stabilization of middle ear prostheses 4. Reconstruction of the posterior canal wall

Source page: https://510kreport.com/device/K042516
Methodology: https://510kreport.com/methodology