# K945105: Poly/Platinum Wire Piston

- Pathway: 510(k) (Traditional)
- Applicant: Micromed Development Corp.
- Decided: May 14, 1996 after 574 days
- Product code: ETB (Prosthesis, Partial Ossicular Replacement)
- Device class: 2
- Regulation: 21 CFR 874.3450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Plast-Pore pistons: named in the summary without a submission number
- (no number) fluoroplastic shaft Platinum pistons: named in the summary without a submission number

## Indications for use
The Poly/Platinum Pistons are intended for the elective reconstruction of the ossicular chain to facilitate conduction of sound energy from the ear drum to the inner ear. The prosthesis is implanted into the middle ear during a tympanoplasty procedure and is retained in the middle ear by the design configuration of the device.

Source page: https://510kreport.com/device/K945105
Methodology: https://510kreport.com/methodology