# K161092: GalaSHAPE 3D

- Pathway: 510(k) (Traditional)
- Applicant: Tepha, Inc.
- Decided: Aug 23, 2016 after 127 days
- Product code: OOD (Surgical Film)
- Device class: 2
- Regulation: 21 CFR 878.3300
- 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: 12 generations back to K921895 (1992). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K162922: GalaFORM 3D (2017), 0 descendants of its own

## Recalls of this device
- Nov 21, 2016 · Class II · Z-0948-2017: Endotoxin values from testing of retains slightly exceeded the established specification.

## Indications for use
GalaSHAPE™ 3D 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. GalaSHAPE™ 3D 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/K161092
Methodology: https://510kreport.com/methodology