# K062630: Ossipro Bone Substitute Material

- Pathway: 510(k) (Traditional)
- Applicant: Etex Corp.
- Decided: Jun 28, 2007 after 296 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: 2 generations back to K011048 (2001). 2 ancestors in all.
26 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033138: CAP3 Bone Substitute Material, Etex Corp. (2003) Summary page 1.
- K011048: BSM Bone Substitute Material, DePuy Orthopaedics, Inc. (2001)

## Cited in the summary but kept off the family tree
- K011057: Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX, OraSure Technologies, Inc. (2001). Our reading of the summary gave K011057, FDA’s number for Intercept Oral Fluid Drug Test Oral Specimen Collection… (OraSure Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “JAX™ Granules Bone Void Filler”. Kept off the family tree.

## Most influential descendants
- K093447: Carrigen (2010), 21 descendants of its own
- K101557: Gamma-BSM, Beta-BSM, Equivabone, Carigen (2010), 10 descendants of its own
- K103799: Inqu Paste Mix Plus (2011), 9 descendants of its own
- K130392: Kinex Bioactive (2013), 8 descendants of its own
- K102528: N-Force Fixation System (2011), 5 descendants of its own

## Indications for use
OssiPro Bone Substitute Material is an injectable, self setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use in filling bone voids or defects of the skeletal system (such as the extremities, spine, and the 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. OssiPro is a bone graft substitute that resorbs and is replaced with new bone during the healing process.

Source page: https://510kreport.com/device/K062630
Methodology: https://510kreport.com/methodology