# K010532: Osteoset BVF Kit

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 26, 2001 after 245 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
No predicates in its family tree.
29 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Wright Plaster of Paris Bone Void Filler Kit: named in the summary without a submission number

## Most influential descendants
- K050025: Nanoss Bone Void Filler (2005), 11 descendants of its own
- K081558: Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC (2008), 10 descendants of its own
- K051951: Cerament Bone Void Filler (2005), 10 descendants of its own
- K091031: Pioneer Surgical Nanoss BVF-E (2009), 7 descendants of its own
- K073316: Cerament Bone Void Filler, Model A0210 (2008), 6 descendants of its own

## Indications for use
The intended use for the OSTEOSET® BVF resultant paste is to be injected, digitally packed into open bone void/gap to cure in-situ; or molded into solid pellets that are gently packed into open bone voids/gap that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste/pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. The OSTEOSET® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. The OSTEOSET® BVF Kit is provided sterile for single use only.

Source page: https://510kreport.com/device/K010532
Methodology: https://510kreport.com/methodology