# K073006: Osteotrans -MX Bioabsorbable Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Takiron Co., Ltd.
- Decided: May 29, 2008 after 218 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904436 (1990). 59 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010352: CPS 1.5/2.0/2.5 Bioabsorbable Fixation System, Inion, Ltd. (2001) Summary page 1.
- K992355: Lactosorb Trauma Plating System, Biomet, Inc. (1999) Summary page 1.
- K971870: Lactosorb Trauma Plating System, Biomet, Inc. (1997) Summary page 1.
- K992905: Codman Craniosorb Absorbable Fixation System, Codman & Shurtleff, Inc. (2000) Summary page 1.
- K003549: Codman Craniosorb Absorbable Fixation System Purple Rivets, Codman & Shurtleff, Inc. (2001) Summary page 1.
- K062819: Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery, Bioplate, Inc. (2006) Summary page 1.
- K061881: Osteotrans -MX Bioabsorbable Bone Fixation System, Takiron Co., Ltd. (2007) Summary page 2.

## Most influential descendants
- K121606: Resorb-X G (2013), 0 descendants of its own
- K101835: Medpor Fixation System-Cranial, Models 80080, 80079 (2010), 0 descendants of its own

## Indications for use
The OSTEOTRANSTM-MX Bioabsorbable Bone Fixation System is intended for use in trauma and reconstructive procedures of the craniofacial skeleton, including fracture of the cranium, infant craniofacial surgery (i.e. craniosynostosis, congenital malformations), pediatric reconstructive procedures, reconstructive procedures of the cranium, craniotomy flap fixation.

Source page: https://510kreport.com/device/K073006
Methodology: https://510kreport.com/methodology