# K061982: Plexur P

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Feb 7, 2007 after 209 days
- Product code: MBP (Filler, Bone Void, Osteoinduction (W/O Human Growth Factor))
- 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 P is intended for use in filling bony voids or gaps of the skeletal system (i.e., extremities, pelvis) 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 is resorbed/remodeled and is replaced by host bone during the healing process.

Source page: https://510kreport.com/device/K061982
Methodology: https://510kreport.com/methodology