# K083780: Superelelastic Nitinol Piston, Superelastic Nitinol Trimmable Piston, Model SPL03.39/40/41/42 (Details in 510(K) Annex 2

- Pathway: 510(k) (Traditional)
- Applicant: Audio Technologies S.R.L.
- Decided: Mar 23, 2009 after 94 days
- Product code: ETA (Replacement, Ossicular Prosthesis, Total)
- Device class: 2
- Regulation: 21 CFR 874.3495
- 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) Richards: named in the summary without a submission number
- (no number) Xomed: named in the summary without a submission number
- (no number) Exmoor: named in the summary without a submission number
- (no number) Audio Technologies prosthesis: named in the summary without a submission number

## Indications for use
Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear. Audio prostheses are successfully employed in case of otosclerosis, stapedo-vestibular ankylosis, outxome of otitis media, trauma, middle ear congenital malformations. Possible complication due to the use of prostheses in the middle ear include: fixation, displacement, extrusion of the prosthesis, incus necrosis, tympanic membrane perforation, perilymph fistula, labyrinthitis, otitis media, occlusion of oval and round window. Some of the prostheses are manufactured in different lengths, some others shall be trimmed during the surgical operation. Nevertheless the length of all the prostheses should be carefully assessed by means of a microsurgical gauge (code 02.14) The implant must be carried out by a qualified surgeon.

Source page: https://510kreport.com/device/K083780
Methodology: https://510kreport.com/methodology