# K051406: Osteocure Resorbable Bead Kit

- Pathway: 510(k) (Traditional)
- Applicant: Nexa Orthopedics, Inc.
- Decided: Aug 1, 2005 after 62 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 K973704 (1998). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031838: Profusion Bone Void Filler Kit, Biogeneration (2003) Summary page 1.
- K973704: Profusion Bone Void Filler, Biogeneration (1998) Summary page 1.
- K010532: Osteoset BVF Kit, Wrightmedicaltechnologyinc (2001) Summary page 1.
- K024336: Miig II Bone Graft Substitute, Wrightmedicaltechnologyinc (2003) Summary page 1.

## Most influential descendants
- K071004: Osteocrete Bone Void Filler (2009), 2 descendants of its own
- K212991: Osteorevive (2022), 1 descendant of its own
- K221256: Mg OSTEOINJECT (2022), 0 descendants of its own

## Indications for use
The paste made with OsteoCure is intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. OsteoCure paste cured in-situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process. OsteoCure Kits are provided sterile for single use only. Because the device is biodegradable and biocompatible, it may be used at an infected site.

Source page: https://510kreport.com/device/K051406
Methodology: https://510kreport.com/methodology