# K013243: Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1

- Pathway: 510(k) (Traditional)
- Applicant: Bioform, Inc.
- Decided: Jan 9, 2002 after 103 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913882 (1992). 10 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974311: Vocom (Vocal Cord Medialization) Implant, Gyrus Ent LLC (1998) Summary page 2.
- K983525: Gore Revox Thyroplasty Implant, W. L. Gore & Associates, Inc. (1998) Summary page 2.
- K982294: Xomed Silicone Pre-Form Blocks, Xomed, Inc. (1998) Summary page 2.

## Most influential descendants
- 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
- K080956: Modification to VF Gel Plus (2008), 3 descendants of its own

## Recalls of this device
- Oct 26, 2015 · Class II · Z-0368-2016: The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

## Indications for use
Coaptite™ is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation.

Source page: https://510kreport.com/device/K013243
Methodology: https://510kreport.com/methodology