# K061881: Osteotrans -MX Bioabsorbable Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Takiron Co., Ltd.
- Decided: Mar 14, 2007 after 254 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K904436 (1990). 33 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 37 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.
- K011569: Biosorbfx O/M 2.0/2/4 System, Bionx Implants, Inc. (2002) Summary page 1.
- K030069: Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation System, Synthes (Usa) (2003) Summary page 1.
- K000696: Macroporemx Mandibular Fixation System, Macropore Biosurgery, Inc. (2000). Our reading of the summary gave K000694, FDA’s number for Pectofix Dynamic Sternal Fixation System (DSF) (Pectofix, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MacroPoreMX Mandibular Fixation System”.
- K980927: Lactosorb Panels and Fasteners, Biomet, Inc. (1998) Summary page 1.

## Most influential descendants
- K073006: Osteotrans -MX Bioabsorbable Bone Fixation System (2008), 2 descendants of its own
- 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 OSTEOTRANSTMIX Bioabsorbable Bone Fixation System is indicated for use in trauma and reconstructive procedures in the craniofacial skeleton, which includes the facial cranium, mid-face, maxilla and mandible.

Source page: https://510kreport.com/device/K061881
Methodology: https://510kreport.com/methodology