# K080511: Plexur-P

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Apr 21, 2008 after 56 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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 no predicate by number.

## Most influential descendants
- K090387: Kainos+ (2009), 0 descendants of its own

## Indications for use
PLEXUR P is intended for use in filling bony voids or gaps of the skeletal system (i.e., spine, pelvis and extremities) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Plexur P may also be used as a bone graft extender in the spine. PLEXUR P is resorbed/remodeled and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K080511
Methodology: https://510kreport.com/methodology