# K992839: Socket Stapes Piston W/O Loop, Schobel, Schobel-Causse

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz GmbH Medizintechnik
- Decided: Sep 16, 1999 after 24 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 (XOMED): named in the summary without a submission number
- (no number) PTFE Polymer Piston (XOMED): named in the summary without a submission number
- (no number) Lippy Modified Stapes Prosthesis (XOMED): named in the summary without a submission number
- (no number) Richards Bucket Handle Prosthesis (XOMED): named in the summary without a submission number
- (no number) Robinson Piston (XOMED): named in the summary without a submission number
- (no number) Shea Cup Piston (XOMED): named in the summary without a submission number
- (no number) Shea Platinum/Fluoroplastic Piston (XOMED): named in the summary without a submission number
- (no number) Fluoroplastic Pistons (Smith & Nephew Richards): named in the summary without a submission number
- (no number) Cup Pistons (Smith & Nephew Richards): named in the summary without a submission number
- (no number) Cupped Pistons (Smith & Nephew Richards): named in the summary without a submission number

## Indications for use
Otosclerosis Surgery: Replacement of the stapes after stapedotomy and stapedectomy. SCHOBEL: Initial and secondary surgery SCHOBEL-CAUSSE: Initial surgery with retention of stapedial muscle reflex. The stapes prostheses and custom accessories are exclusively intended for use by qualified medical personnel trained in middie ear reconstructive surgery.

Source page: https://510kreport.com/device/K992839
Methodology: https://510kreport.com/methodology