# K981045: Exmoor Teflon Loop Replacement Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Exmoor Plastics, Ltd.
- Decided: May 20, 1998 after 61 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) Causse Tef-Piston: named in the summary without a submission number
- (no number) Causse Tef-Piston Large Loop: named in the summary without a submission number
- (no number) Shea Malleus Teflon Piston: named in the summary without a submission number
- (no number) Causse Modified Teflon Piston: named in the summary without a submission number

## Indications for use
This prosthesis can be used to reconstruct an absent or defective stapes and incus.

Source page: https://510kreport.com/device/K981045
Methodology: https://510kreport.com/methodology