# K150594: Biodesign Otologic Repair Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorprated
- Decided: Sep 16, 2015 after 191 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 K982870 (1998). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982870: Epifilm Otologic Lamina, Xomed, Inc. (1998) Summary page 4.
- K001148: Merogel Otologic Pack, Xomed, Inc. (2000) Summary page 4.

## Most influential descendants
- K161000: Biodesign Otologic Repair Graft (2016), 1 descendant of its own
- K232646: Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9) (2024), 0 descendants of its own

## Indications for use
The Biodesign Otologic Repair Graft is intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K150594
Methodology: https://510kreport.com/methodology