# K991854: Osteoplast, Model POP200

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Aug 26, 1999 after 86 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
Longest line of descent: 1 generation back to K963587 (1997). 2 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963587: Wright Plaster of Paris Bone Void Filler Kit (Subject to Revision), Wrightmedicaltechnologyinc (1997) Summary page 1.
- K963562: Wright Plaster of Paris Pellets, Wrightmedicaltechnologyinc (1997) Summary page 1.

## Most influential descendants
- K031319: Osteo-G Bone Void Filler System (2003), 4 descendants of its own
- K033258: Bonesave Bone Void Filler (2004), 3 descendants of its own
- K091688: A-Grix Resorbable Bone Void Filler (2010), 1 descendant of its own
- K121453: A-Grix TE Resorable Bone Void Filler (2013), 0 descendants of its own
- K072444: Wellgraft PE I (2008), 0 descendants of its own

## Indications for use
Osteoplast Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteoplast 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 replaced with bone during the healing process. Because the Pellets are biodegradable and biocompatible, it may be used at an infected site.

Source page: https://510kreport.com/device/K991854
Methodology: https://510kreport.com/methodology