# K122561: Adaptain Fastwrap, Envelock, Graftain

- Pathway: 510(k) (Traditional)
- Applicant: Ceremed, Inc.
- Decided: Nov 27, 2012 after 97 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: 8 generations back to K791495 (1979). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120220: Adaptain Soluble Implant Material, Ceremed, Inc. (2012) Summary page 1.

## Most influential descendants
- K132198: Adaptain, Adaptain Fastwrap, Envelock, Biowai (2013), 0 descendants of its own

## Indications for use
Adaptain FastWrap m is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Source page: https://510kreport.com/device/K122561
Methodology: https://510kreport.com/methodology