510(k) Report

510(k) · Cleared

Cleared

Osteotrans -MX Bioabsorbable Bone Fixation System

K061881510(k) TraditionalCleared Mar 14, 2007254-day reviewClass II21 CFR 872.4760

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

Takiron Co., Ltd. · JEY Plate, Bone

Cleared on Mar 14, 2007 as substantially equivalent to K010352 (Inion, Ltd., 2001) and 4 other predicates after a 254-day review. Its family tree reaches back 6 generations to 1990. 3 later devices descend from it.

Decided
Mar 14, 2007
Review
254 days
Class
Class II
Product code
JEY
Recalls
None
Predicates
5

Its longest line of descent runs back 6 generations to K904436 (1990). 33 ancestors in all, the oldest K862532 (1986). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 3 other ancestors2000: 1 other ancestor1998: 5 other ancestors1999: 2 other ancestors1997: 2 other ancestors1996: 6 other ancestors1986: 1 other ancestor1995: 3 other ancestors1992: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor2008: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant clearedK904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996×3: 3 generations cleared close together, K972783 (1998), K982139 (1998), K982721 (1999) K011569 · Biosorbfx O/M 2.0/2/4 System · Bionx Implants, Inc. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors3 generations back: 7 other ancestors4 generations back: 9 other ancestors5 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants K011569 · Biosorbfx O/M 2.0/2/4 System · Bionx Implants, Inc. · 2002K982721 · Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation System · Bionx Implants, Inc. · 1999K982139 · Biosorbfx 1.5/2.0 Bioabsorbable Fixation System · Bionx Implants, Inc. · 1998K972783 · Biofix Biodegradable Threaded Suture Anchor · Bionx Implants, Inc. · 1998K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990−50
  1. Root · 6 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
  2. 5 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
  3. 4 generations backK972783 Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc. · 1998
  4. 3 generations backK982139 Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc. · 1998
  5. 2 generations backK982721 Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc. · 1999
  6. 1 generation backK011569 Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc. · 2002
  7. This deviceK061881 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007
  8. Descendant · cites it directly · 2 of its ownK073006 Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
  9. Descendant · 2 generations on · 0 of its ownK121606 Resorb-X GKLS-Martin L.P. · 2013
  10. Descendant · 2 generations on · 0 of its ownK101835 Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010

Most influential descendants

Showing 3 of 3 · See all
  • K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008 · cites it directly2descendants
  • K121606Resorb-X GKLS-Martin L.P. · 2013 · 2 generations on0descendants
  • K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K904436Quickanchor (TM)Mitek Surgical Products, Inc.1990—
−5K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996—
−4K972783Biofix Biodegradable Threaded Suture AnchorBionx Implants, Inc.1998—
−3K982139Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemBionx Implants, Inc.1998—
−2K982721Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemBionx Implants, Inc.1999—
−1K011569Biosorbfx O/M 2.0/2/4 SystemBionx Implants, Inc.2002—
0 (this device)K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.2007—
+1K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.2008—
+2K121606Resorb-X GKLS-Martin L.P.2013—
+2K101835Medpor Fixation System-Cranial, Models 80080, 80079Porex Surgical, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199210
199310
199410
199530
199660
199720
199850
199920
200010
200130
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201310
FIG. 1 — Lineage of K061881, 1990–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 JEY? 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 JEY device

  1. #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K010352CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
Summary page 1
…akiron Co., Ltd. has not yet obtained an Establishment Registration Number. Legally Marketed Predicate Devices: Inion CPSTm 1.5/2.0/2.5 Bioabsorbable Fixation System (K(010352) BioSorbFXTM O/M 2.0/2.4 Bloabsorbable Fixation System (K0 11569) Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation Syste…
Inion, Ltd.20013
*K011569Biosorbfx O/M 2.0/2/4 System
Summary page 1
…tion Number. Legally Marketed Predicate Devices: Inion CPSTm 1.5/2.0/2.5 Bioabsorbable Fixation System (K(010352) BioSorbFXTM O/M 2.0/2.4 Bloabsorbable Fixation System (K0 11569) Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System (1K030069) MacroPoreMX Mandibular Fixation System (K(000694) La…
Bionx Implants, Inc.2002—
*K030069Synthes Poly (L-Lactide-CO-Glycolide) Resorbable Fixation System
Summary page 1
…absorbable Fixation System (K(010352) BioSorbFXTM O/M 2.0/2.4 Bloabsorbable Fixation System (K0 11569) Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System (1K030069) MacroPoreMX Mandibular Fixation System (K(000694) LactoSorb Panels and Fasteners (K980927)…
Synthes (Usa)20033
*K000696Macroporemx Mandibular Fixation System
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”.
Macropore Biosurgery, Inc.2000—
*K980927Lactosorb Panels and Fasteners
Summary page 1
…(K0 11569) Synthes Poly (L-Lactide-co-Glycolide) Resorbable Fixation System (1K030069) MacroPoreMX Mandibular Fixation System (K(000694) LactoSorb Panels and Fasteners (K980927) 5-1…
Biomet, Inc.19981

Also cleared against K010352: 8 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd.20082

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 17 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
  • 5 of the 33 ancestors have a recall of any class.
  • Of its descendants, K073006 (Takiron Co., Ltd., 2008) has gone furthest, with 2 descendants of its own.
  • 8 other devices also cite its predicate K010352.

How does its category compare?

All JEY devices

JEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · JEY

2in 2025

2007: 92008: 72009: 42010: 62011: 52012: 102013: 82014: 62015: 72016: 12017: 52018: 72019: 62020: 62021: 42022: 52023: 22024: 52025: 22026 (partial year): 3
2007high 10 (2012) · low 1 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JEY

159in 2024

2007: 115 days median2008: 84 days median2009: 121 days median2010: 199 days median2011: 75 days median2012: 194 days median2013: 126 days median2014: 223 days median2015: 160 days median2017: 190 days median2018: 255 days median2019: 163 days median2020: 198 days median2021: 299 days median2022: 135 days median2024: 159 days median2026 (partial year): 258 days median
2007high 299 (2021) · low 75 (2011)2026

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

Recalls per year · JEY

1in 2020

2008: 32009: 62010: 852013: 12020: 1
2007high 85 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JEY

1,003in 2025

2007: 292008: 242009: 932010: 2152011: 2412012: 4282013: 7662014: 6162015: 7672016: 5582017: 5682018: 6082019: 5952020: 6802021: 4512022: 3442023: 4952024: 6962025: 1,003
2007high 1,003 (2025) · low 24 (2008)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20079115029
2008784324
20094121693
2010619985215
20115750241
2012101940428
201381261766
201462230616
201571600767
20161—0558
201751900568
201872550608
201961630595
202061981680
202142990451
202251350344
20232—0495
202451590696
20252—01,003
202632580—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

Also cleared against K010352

8 other devices cite the same predicate.

  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025
  • K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OY · 2025
  • K122890Inion CPS Orbital PlatesInion OY · 2013
  • K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
  • K063410Inion CPS/Otps FreedomplateInion, Ltd. · 2007
  • K022981Inion CPS 2.5/2.8 ScrewInion, Ltd. · 2002

More from Takiron Co., Ltd.

6 FDA decisions under this applicant name. See the company

  • K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd. · 2008
  • K073006Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2008
  • K073311Osteotrans-OT PinTakiron Co., Ltd. · 2008
  • K073312Osteotrans-OT ScrewTakiron Co., Ltd. · 2008
  • K062691ComporusTakiron Co., Ltd. · 2008

Recent decisions in JEY

The JEY category page

  • K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual…KLS-Martin L.P. · 2026
  • K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd. · 2026
  • K252246Leforte MMF SystemJeil Medical Corporation · 2026
  • K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty), Ltd. · 2025
  • K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY · 2025

https://510kreport.com/device/K061881 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061881: 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/K061881

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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