# K963562: Wright Plaster of Paris Pellets

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: May 7, 1997 after 244 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.
383 later devices descend from it; 9 cite it directly.
0 of 384 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) Plaster of Paris Pellets (Ethicon): named in the summary without a submission number

## Most influential descendants
- K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L (1998), 312 descendants of its own
- K020078: Exactech Resorbable Bone Paste (2004), 186 descendants of its own
- K021336: Novabone-Resorbable Bone Graft Substitute (2002), 162 descendants of its own
- K030131: Ossatura BCP Bone Void Filler (2003), 133 descendants of its own
- K052494: Novabone-Bioactive Synthetic Graft (2005), 123 descendants of its own

## Indications for use
Wright Plaster of Paris Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Wright Plaster of Paris Pellets are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is repiaced with bone during the healing process. Because the pellets are biodegradable and biocompatible, they may be used at an infected site.

Source page: https://510kreport.com/device/K963562
Methodology: https://510kreport.com/methodology