# K141725: Bongold Bone Graft Material

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Allgens Medical Science & Technology Co, L
- Decided: Jul 9, 2015 after 378 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: 4 generations back to K960978 (1996). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012751: Healos Bone Graft Material, Orquest, Inc. (2001) Summary page 4.

## Most influential descendants
- K220337: GaiaBone Bioabsorbable Bone Graft (2023), 0 descendants of its own

## Indications for use
Bongold is an implant intended to fill bony voids or gaps of the skeletal system, i.e., the pelvis and extremities. Bongold must be used with autograft as a bone graft extender in the extremities. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stablllty of the bony structure. Bongold resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K141725
Methodology: https://510kreport.com/methodology