# K081227: Plexur M

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Jul 22, 2008 after 83 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

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

Source page: https://510kreport.com/device/K081227
Methodology: https://510kreport.com/methodology