510(k) · Cleared

Cleared

Osteotrans -MX Bioabsorbable Bone Fixation System

K073006510(k) TraditionalCleared May 29, 2008218-day reviewClass II21 CFR 882.5320

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Takiron Co., Ltd. · GWO Plate, Cranioplasty, Preformed, Alterable

Cleared on May 29, 2008 as substantially equivalent to K010352 (Inion, Ltd., 2001) and 6 other predicates after a 218-day review. Its family tree reaches back 7 generations to 1990. 2 later devices descend from it.

Decided: May 29, 2008
Review: 218 days
Class: Class II
Product code: GWO
Recalls: None
Predicates: 7

Its longest line of descent runs back 7 generations to K904436 (1990). 59 ancestors in all, the oldest K854886 (1986). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 7 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
6 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
5 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
4 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
3 generations backK982721 Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc. · 1999
2 generations backK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
1 generation backK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
This deviceK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
Descendant · cites it directly · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
Descendant · cites it directly · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010

Most influential descendants

Showing 2 of 2 · See all

K121606Resorb-X GKLS-Martin L.P. · 2013 · cites it directly0descendants
K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K904436	Quickanchor (TM)	Mitek Surgical Products, Inc.	1990	—
−6	K962397	Statak Soft Tissue Attachment Device	Zimmer, Inc.	1996	—
−5	K972783	Biofix Biodegradable Threaded Suture Anchor	Bionx Implants, Inc.	1998	—
−4	K982139	Biosorbfx 1.5/2.0 Bioabsorbable Fixation System	Bionx Implants, Inc.	1998	—
−3	K982721	Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System	Bionx Implants, Inc.	1999	—
−2	K011569	Biosorbfx O/M 2.0/2/4 System	Bionx Implants, Inc.	2002	—
−1	K061881	Osteotrans -MX Bioabsorbable Bone Fixation System	Takiron Co., Ltd.	2007	—
0 (this device)	K073006	Osteotrans -MX Bioabsorbable Bone Fixation System	Takiron Co., Ltd.	2008	—
+1	K121606	Resorb-X G	KLS-Martin L.P.	2013	—
+1	K101835	Medpor Fixation System-Cranial, Models 80080, 80079	Porex Surgical, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	2	0
1990	1	0
1991	2	0
1992	3	0
1993	3	0
1994	4	0
1995	6	0
1996	6	0
1997	4	0
1998	8	0
1999	4	0
2000	2	0
2001	4	0
2002	1	0
2003	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2013	1	0

FIG. 1 — Lineage of K073006, 1990–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GWO device

#1 K261058 CraniUS Platescore 16.8 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K010352	CPS 1.5/2.0/2.5 Bioabsorbable Fixation System Summary page 1 …as not yet obtained an Establishment Registration Number. Legally Marketed Predicate Devices: 1. Inion Ltd.; Inion CPS TM 1.5/2.0/2.5 Bioabsorbable Fixation System (K.010352) 2. Biomet, Inc.; LactoSorb® Trauma Plating System (K.992355, K971870) 3. Codman & Shurtleff, Inc.; Codman® CraniosorbTM Abso…	Inion, Ltd.	2001	3
*	K992355	Lactosorb Trauma Plating System Summary page 1 …lly Marketed Predicate Devices: 1. Inion Ltd.; Inion CPS TM 1.5/2.0/2.5 Bioabsorbable Fixation System (K.010352) 2. Biomet, Inc.; LactoSorb® Trauma Plating System (K.992355, K971870) 3. Codman & Shurtleff, Inc.; Codman® CraniosorbTM Absorbable Fixation System (K992905, K003549) 4. Bioplate I…	Biomet, Inc.	1999	—
*	K971870	Lactosorb Trauma Plating System Summary page 1 …eted Predicate Devices: 1. Inion Ltd.; Inion CPS TM 1.5/2.0/2.5 Bioabsorbable Fixation System (K.010352) 2. Biomet, Inc.; LactoSorb® Trauma Plating System (K.992355, K971870) 3. Codman & Shurtleff, Inc.; Codman® CraniosorbTM Absorbable Fixation System (K992905, K003549) 4. Bioplate Inc.; Modi…	Biomet, Inc.	1997	—
*	K992905	Codman Craniosorb Absorbable Fixation System Summary page 1 …(K.010352) 2. Biomet, Inc.; LactoSorb® Trauma Plating System (K.992355, K971870) 3. Codman & Shurtleff, Inc.; Codman® CraniosorbTM Absorbable Fixation System (K992905, K003549) 4. Bioplate Inc.; Modified plate design for use in conjunction with the Bioplate Rigid Bone Plating System for…	Codman & Shurtleff, Inc.	2000	—
*	K003549	Codman Craniosorb Absorbable Fixation System Purple Rivets Summary page 1 …2) 2. Biomet, Inc.; LactoSorb® Trauma Plating System (K.992355, K971870) 3. Codman & Shurtleff, Inc.; Codman® CraniosorbTM Absorbable Fixation System (K992905, K003549) 4. Bioplate Inc.; Modified plate design for use in conjunction with the Bioplate Rigid Bone Plating System for Craniomax…	Codman & Shurtleff, Inc.	2001	—
*	K062819	Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery Summary page 1 …(K992905, K003549) 4. Bioplate Inc.; Modified plate design for use in conjunction with the Bioplate Rigid Bone Plating System for Craniomaxillofacial Surgery (K.062819) 5. Takiron Co., Ltd.; OSTEOTRANSrM-MX Bioabsorbable Bone Fixation System (K.061881)…	Bioplate, Inc.	2006	—
*	K061881	Osteotrans -MX Bioabsorbable Bone Fixation System Summary page 2 …The OSTEOTRANS M-MX Bioabsorbable Bone Fixation System is identical with the implants in the previously 510(k) cleared OSTEOTRANS-MX Bioabsorbable Bone Fixation System (K061881) in terms of composition, manufacturing method, sterilization method and packaging solution. The OSTEOTRANSI*m-MX Bioabsorbable B…	Takiron Co., Ltd.	2007	—

Also cleared against K010352: 8 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121606	Resorb-X G	KLS-Martin L.P.	2013	0
K101835	Medpor Fixation System-Cranial, Models 80080, 80079	Porex Surgical, Inc.	2010	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
7 of the 59 ancestors have a recall of any class.
Of its descendants, K121606 (KLS-Martin L.P., 2013) has gone furthest, with 0 descendants of its own.
8 other devices also cite its predicate K010352.

How does its category compare?

All GWO devices

GWO Plate, Cranioplasty, Preformed, Alterable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · GWO

2in 2025

2007high 5 (2012) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWO

196in 2019

2007high 249 (2013) · low 109 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GWO

2in 2015

2007high 2 (2015) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GWO

237in 2025

2007high 237 (2025) · low 0 (2007)2025

MAUDE reports naming product code GWO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	0
2008	1	—	0	3
2009	0	—	0	2
2010	1	—	0	7
2011	2	—	0	1
2012	5	133	0	5
2013	4	249	0	7
2014	3	109	0	11
2015	3	210	2	18
2016	3	125	0	18
2017	2	—	0	47
2018	1	—	0	41
2019	4	196	0	14
2020	0	—	0	25
2021	1	—	0	41
2022	2	—	0	53
2023	0	—	0	72
2024	1	—	0	149
2025	2	—	0	237
2026	2	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073006 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073006: Osteotrans -MX Bioabsorbable Bone Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073006

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026