# K970910: Xomed Silicone Block/Strip

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: May 2, 1997 after 51 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
Longest line of descent: 1 generation back to K913882 (1992). 2 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953013: Merocel Reinforced Silicone Sheets, Merocel Corp. (1995) Summary page 1.
- K913882: Zara Silicone Block, Byron Medical (1992) Summary page 1.
- (no number) Xomed Silicone Sheeting: named in the summary without a submission number
- (no number) Xomed Silicone Block: named in the summary without a submission number
- (no number) Dow Silicone Block: named in the summary without a submission number
- (no number) McGhan Silicone Block: named in the summary without a submission number

## Most influential descendants
- K972317: Montgomery Thyroplasty Implant System (1997), 14 descendants of its own
- 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

## Indications for use
The Silicone Blocks/Strips are intended for use as an implant material to aid in surgical repairs in various otorhinolaryngological surgical procedures and space occupying augmentation in reconstructive Head & Neck surgery.

Source page: https://510kreport.com/device/K970910
Methodology: https://510kreport.com/methodology