# K990601: Bojrab Micro-Torp, Model 7014-5845

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Mar 31, 1999 after 35 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) Black Oval-Top TORP: named in the summary without a submission number
- (no number) Schwaber Total implant: named in the summary without a submission number

## Indications for use
Otosclerosis Congenital fixation of the stapes When previous remedial surgery has been unsuccessful for the treatment of hearing loss due to otosclerosis, and a significant conductive loss remains with good cochlear reserve. Chronic middle ear disease Trauma

Source page: https://510kreport.com/device/K990601
Methodology: https://510kreport.com/methodology