# K974311: Vocom (Vocal Cord Medialization) Implant

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Ent LLC
- Decided: Mar 4, 1998 after 107 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices 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) Montgomery® Thyroplasty Implant System: named in the summary without a submission number
- (no number) Hydroxylapatite Bone Graft Material: named in the summary without a submission number

## Most influential descendants
- 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
- K071663: VF Gel Plus (2008), 4 descendants of its own

## Indications for use
The Smith & Nephew, Inc., ENT Division, Vocal Cord Medialization System is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.

Source page: https://510kreport.com/device/K974311
Methodology: https://510kreport.com/methodology