# K162922: GalaFORM 3D

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Feb 23, 2017 after 128 days
- Product code: OOD (Surgical Film)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K921895 (1992). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161092: GalaSHAPE 3D, Tepha, Inc. (2016) Summary page 4.
- K140533: Galaflex Mesh, Tepha, Inc. (2014) Summary page 4.

## Indications for use
GalaFORM 3D scaffold is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. GalaFORM 3D scaffold is also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K162922
Methodology: https://510kreport.com/methodology