# K072444: Wellgraft PE I

- Pathway: 510(k) (Traditional)
- Applicant: Gwowei Technology Co., Ltd.
- Decided: Apr 4, 2008 after 242 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K963587 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031319: Osteo-G Bone Void Filler System, Aspine USA, Inc. (2003) Summary page 1.

## Indications for use
WELLGRAFT PE I Resorbable Bone Void Filler is indicated to fill bony void or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bone structure. These defects may be surgically created osseous defects created from traumatic injury to the bone. The bone void filler resorbs and is replaced with new bone during the healing process. Wellgraft PE I may be used at an infected site. When used in the spine, the device is limited to posterolateral fusion procedures only.

Source page: https://510kreport.com/device/K072444
Methodology: https://510kreport.com/methodology