# K002897: Titanium Middle Ear Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Oct 11, 2000 after 23 days
- Product code: ETB (Prosthesis, Partial Ossicular Replacement)
- Device class: 2
- Regulation: 21 CFR 874.3450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K130512: Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis (2013), 2 descendants of its own
- K241142: mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (2025), 1 descendant of its own
- K260720: mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); (2026), 0 descendants of its own

## Recalls of this device
- Aug 23, 2013 · Class II · Z-2284-2013: One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.

Source page: https://510kreport.com/device/K002897
Methodology: https://510kreport.com/methodology