A New Generation Bioresorbable Bone Conductive Devices Acquires 510(k)
Approval from the US FDA
In March 2007, Takiron Co., Ltd. (Chuo-ku, Osaka-shi; President: Seiji Morishita) acquired 510(k)
approval (marketing approval) from the US Food and Drug Administration (FDA) for a new-
generation bone-bonding material that exhibits bioactivity (bonds directly to bone and is totally
replaced with bone) and is also biologically degraded and resorbed (foreign trade name:
OSTEOTRANS MX, Japanese trade name: SUPER FIXSORB MX).
This bone-bonding material had already acquired regulatory approval in Europe in August 2005 and
is currently exported to Europe under the brand name “
OSTEOTRANS.”The scope of approval in
the U.S. is for the maxillofacial surgery. We are ready to export and distribute this product to the U.S.
with the present approval. We will also obtain approval for orthopedic, trauma, and neurological
surgeries.
The market for bone-bonding materials (mainly metallic) for orthopedic/trauma/neurological
surgeries in the U.S. is approximately 5 to 7 times larger than that in Japan and is estimated to be
worth about 50 billion yen per year. We aim to obtain overseas sales of more than 1 billion yen in
fiscal 2008, including U.S. sales.
Most medical devices in Japan, such as bone- bonding materials, depend on the import of foreign
products. We think it is significant that we are about to launch a Japanese medical technology into
the global market and that this new Japan-derived biomaterial will now be used in Europe and in the
U.S.
This product has already been patented in the U.S.
Reference data
1. Outline of approval
Approval date: March 14, 2007
Approval No.: K061881
2. Approval items
(1) Shape and composition
Bioresorbable bone conductive devices in the shape of plate, mesh, and screw, etc. that
consists of a composite of bioresorbable hydroxyapatite (u-HA) particles and poly-L-lactic
acid (PLLA)
(2) Intended use

Trauma and reconstructive procedures in the cranial and maxillofacial regions
3. OSTEOTRANS
(3) Outline
OSTEOTRANS consists of a reinforced composite material of bioresorbable HA particles
and PLLA and has both bioresorbability and bioactivity (has osteoconductivity and is
totally replaced with bone). It is categorized as a bioresorbable, osteoconductive device
that is positioned as a globally available new generation biomaterial.
(4) Product features
1) Mechanical properties: The mechanical properties of the product include enhanced
strength (bending strength: 270 Megapascals, impact strength: more than twice that of
conventional products, compression strength: approximately ten times of human
cortical bone) with a rigidity close to that of human cortical bone (bending elastic
modulus: 7.6 Gigapascals).
2) Degradation/bioresorption: Time for complete degradation/bioresorption is reduced.
3) Osteoconductivity and bone replacement: Since new bone is formed around the devices
through biodegradation/bioresorption progresses, the material is totally replaced with
new bone and no drilled bone hole for implanting result.
4) In vivo bonding to bone: It bonds directly to surrounding bone and enables a reliable
initial fixation.
5) Biocompatibility and safety: The raw bioresorbable u-HA particles in the device
provide further improvement in terms of biocompatibility and safety.
6) Radiopacity: Changes in the condition with time of the device can be observed
postoperatively using X-ray images because u- HA is radiopaque.
Reference FDA 510(k)
510(k) refers to an application submitted to the U.S. Food and Drug Administration (FDA); it is
generally viewed as a national standard set by the FDA for the marketing of medical devices in the
U.S. 510(k) specifies strict rules for proper labeling (including accurate advertising) and also has
rules relating to the safety and efficacy of the product.
If you have any further questions, please contact:
Keiichiro Koyama, Medical Division, Takiron Co., Ltd.
TEL: (06)6267-2809
FAX: (06)6267-2801