# K972317: Montgomery Thyroplasty Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Products, Inc.
- Decided: Sep 18, 1997 after 90 days
- Product code: MIX (System, Vocal Cord Medialization)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913882 (1992). 6 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955368: Duralastic I, Allied Biomedical Corp. (1996) Summary page 1.
- K955370: Duralastic II, Allied Biomedical Corp. (1996) Summary page 1.
- K955433: Duralastic Silicone Tubing, Allied Biomedical Corp. (1996) Summary page 1.
- K970910: Xomed Silicone Block/Strip, Xomed, Inc. (1997) Summary page 1.
- (no number) Silicone Block (Bentec Medical): named in the summary without a submission number

## Most influential descendants
- K982294: Xomed Silicone Pre-Form Blocks (1998), 12 descendants of its own
- K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1 (2002), 11 descendants of its own
- K033398: Laryngeal Augmentation Implant (2003), 10 descendants of its own
- K060815: Juliesse Injectable Laryngeal Augmentation Implant (2006), 6 descendants of its own
- K070090: Radiesse Laryngeal Implant (2007), 5 descendants of its own

## Indications for use
The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve quality of vocalization.

Source page: https://510kreport.com/device/K972317
Methodology: https://510kreport.com/methodology