# K060809: Osteo-Link Bone Void Filler Pellets

- Pathway: 510(k) (Traditional)
- Applicant: Promed Advance Technology Co., Ltd.
- Decided: Jul 3, 2006 after 101 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: 1 generation back to K963562 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963562: Wright Plaster of Paris Pellets, Wrightmedicaltechnologyinc (1997) Summary page 1.

## Most influential descendants
- K083279: Caltrix Resorbable Bone Void Filler (2009), 0 descendants of its own

## Indications for use
Osteo-Link Bone Void Filler Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. These pellets are indicated to be gently packed into bony voids or gap of the skeletal system; such as the extremities, spine and pelvis. Theses defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide the bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K060809
Methodology: https://510kreport.com/methodology