# K063374: Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and Footplate Shoe

- Pathway: 510(k) (Traditional)
- Applicant: Grace Medical, Inc.
- Decided: Dec 6, 2006 after 28 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
Longest line of descent: 3 generations back to K002221 (2000). 12 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033554: Smart Offset Stapes Piston; Smart Isj Prosthesis, Gyrus Ent LLC (2003) Summary page 1.
- K003214: Smith & Nephew Pistons, Gyrus Ent LLC (2000) Summary page 1.
- K972492: Bell Prosthesis (Partial), Heinz Kurz (1997) Summary page 1.
- K042503: Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MM, Heinz Kurz GmbH Medizintechnik (2004) Summary page 1.
- K021479: Clip Piston Awengen, Model# 1006 805 - 1006 861, Heinz Kurz GmbH Medizintechnik (2002) Summary page 1.
- K061853: Grace Medical Adjustable and Fixed Length Partial & Total Ossicular Replacement Prostheses, Grace Medical, Inc. (2006) Summary page 1.
- K972815: Partial/Total/Porous Polyethylene Ossicular Replacement, Grace Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K112616: Nitibond Stapes Prosthesis, Nitiplast Stapes Prosthesis (2013), 3 descendants of its own
- K130512: Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis (2013), 2 descendants of its own
- K241142: mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (2025), 1 descendant of its own
- K260720: mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); (2026), 0 descendants of its own

## Indications for use
An ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. Ossicular replacement prostheses are indicated for the functional restoration of the ossicular chain when a conductive hearing loss is present. Indications for use include: (a) Chronic middle ear disease, (b) Otosclerosis, (c) Congenital fixation of the stapes, (d) Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, and (e) Surgically correctible injury to the middle ear from trauma.

Source page: https://510kreport.com/device/K063374
Methodology: https://510kreport.com/methodology