510(k) Report

510(k) · Cleared

Cleared

Osteotrans-OT Screw

K073312510(k) TraditionalCleared May 13, 2008172-day reviewClass II21 CFR 888.3040

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

Takiron Co., Ltd. · HWC Screw, Fixation, Bone

Cleared on May 13, 2008 as substantially equivalent to K003077 (Bionx Implants, Ltd., 2001) and 2 other predicates after a 172-day review. Its family tree reaches back 4 generations to 1979.

Decided
May 13, 2008
Review
172 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K792022 (1979). 14 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1995: 3 other ancestors1993: 1 other ancestor1997: 1 other ancestor1996: 2 other ancestorsK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalledK974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K020222 · Wisorb Malleolar Screw · Cambridge Scientific, Inc. · 2002K040265 · Little Grafter Screw · Biocomposites, Ltd. · 200419751980198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 4 other ancestors K040265 · Little Grafter Screw · Biocomposites, Ltd. · 2004K020222 · Wisorb Malleolar Screw · Cambridge Scientific, Inc. · 2002K974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled0
  1. Root · 4 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
  2. 3 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
  3. 2 generations backK020222 Wisorb Malleolar ScrewCambridge Scientific, Inc. · 2002
  4. 1 generation backK040265 Little Grafter ScrewBiocomposites, Ltd. · 2004
  5. This deviceK073312 Osteotrans-OT ScrewTakiron Co., Ltd. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K792022Herbert Bone ScrewZimmer, Inc.19796
−3K974876Bionx Distal Radius ScrewBionx Implants, Inc.1998—
−2K020222Wisorb Malleolar ScrewCambridge Scientific, Inc.2002—
−1K040265Little Grafter ScrewBiocomposites, Ltd.2004—
0 (this device)K073312Osteotrans-OT ScrewTakiron Co., Ltd.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199530
199620
199710
200010
200110
200210
FIG. 1 — Lineage of K073312, 1979–2008Source: 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 HWC? 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 HWC device

  1. #1 K203011 Monster Screw Systemscore 22.2 · 14 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? (3)

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
*K003077Smartscrew Model 222006...227510
Summary page 1
…istration Number: Takiron Co., Ltd. has not yet obtained an Establishment Registration Number. Legally Marketed Predicate Devices: 1. Bionx Implants Ltd.; SmartScrew (K003077) 2. Cambridge Scientific, Inc.; WISORBTM Malleolar Screw (K020222) 3. Biocomposites Ltd.; Little GrafterTM Screw (K040265) I…
Bionx Implants, Ltd.2001—
*K020222Wisorb Malleolar Screw
Summary page 1
…hment Registration Number. Legally Marketed Predicate Devices: 1. Bionx Implants Ltd.; SmartScrew (K003077) 2. Cambridge Scientific, Inc.; WISORBTM Malleolar Screw (K020222) 3. Biocomposites Ltd.; Little GrafterTM Screw (K040265) Intended Use: The OSTEOTRANSTM-OT Screw is intended for maintenance o…
Cambridge Scientific, Inc.2002—
*K040265Little Grafter Screw
Summary page 1
…ices: 1. Bionx Implants Ltd.; SmartScrew (K003077) 2. Cambridge Scientific, Inc.; WISORBTM Malleolar Screw (K020222) 3. Biocomposites Ltd.; Little GrafterTM Screw (K040265) Intended Use: The OSTEOTRANSTM-OT Screw is intended for maintenance of alignment and fixation of fractures, osteotomies, arthro…
Biocomposites, Ltd.2004—

Also cleared against K003077: 9 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 29 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
  • 2 of the 14 ancestors have a recall of any class.
  • 9 other devices also cite its predicate K003077.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · HWC

15in 2025

2007: 352008: 332009: 272010: 232011: 352012: 202013: 252014: 312015: 412016: 262017: 402018: 202019: 302020: 282021: 262022: 262023: 242024: 172025: 152026 (partial year): 21
2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007: 77 days median2008: 76 days median2009: 113 days median2010: 110 days median2011: 88 days median2012: 99 days median2013: 90 days median2014: 88 days median2015: 85 days median2016: 131 days median2017: 127 days median2018: 106 days median2019: 108 days median2020: 75 days median2021: 84 days median2022: 167 days median2023: 104 days median2024: 90 days median2025: 111 days median2026 (partial year): 125 days median
2007high 167 (2022) · low 75 (2020)2026

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

Recalls per year · HWC

1in 2025

2007: 252008: 332009: 292010: 72011: 122012: 302013: 142014: 22015: 52016: 42017: 42018: 12019: 52020: 42021: 22022: 132025: 12026 (partial year): 2
2007high 33 (2008) · low 0 (2023)2026

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

Adverse event reports per year · HWC

2,893in 2025

2007: 6692008: 6602009: 6512010: 7652011: 1,1042012: 3,3392013: 3,8502014: 2,5492015: 2,7112016: 2,2852017: 2,5612018: 3,6622019: 5,4632020: 4,8202021: 4,4462022: 3,9342023: 3,7182024: 3,5752025: 2,893
2007high 5,463 (2019) · low 651 (2009)2025

MAUDE reports naming product code HWC, 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
2007357725669
2008337633660
20092711329651
2010231107765
20113588121,104
20122099303,339
20132590143,850
2014318822,549
2015418552,711
20162613142,285
20174012742,561
20182010613,662
20193010855,463
2020287544,820
2021268424,446
202226167133,934
20232410403,718
2024179003,575
20251511112,893
2026211252—

What is it indicated for?

The OSTEOTRANS M-OT Screw is intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses or bone grafts, including phalangeal fractures, metacarpal fractures, carpal fusion and fractures, wrist arthrodesis, distal radius fractures, olecranon fractures, radial head fractures, cancellous fractures and osteotomies of the malleolus, ankle fractures, metatarsal osteotomies, and correction of hallux valgus.

Indications for use as stated in the FDA summary.

Also cleared against K003077

9 other devices cite the same predicate.

  • K061763Arc Surgical Biotrak ScrewArc Surgical, LLC · 20061 recall
  • K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005
  • K043176Arc Surgical Resorbable Compression Screw SystemArc Surgical, LLC · 2005
  • K043142Inion Otps Biodegradable Mini Plating SystemInion, Ltd. · 2005
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DSArthrex, Inc. · 2005
  • K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd. · 2004

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
  • K062691ComporusTakiron Co., Ltd. · 2008
  • K061881Osteotrans -MX Bioabsorbable Bone Fixation SystemTakiron Co., Ltd. · 2007

Recent decisions in HWC

The HWC category page

  • K261961Ntegrate Threaded Nail SystemNvision Biomedical Technologies · 2026
  • K263116OsteoCentric Technologies Cannulated and Soild Fasteners with NutsOsteoCentric Technologies · 2026
  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K260995DynaNail Helix® Fixation SystemMedShape, Inc. · 2026
  • K254280F.A.S.T ScrewSteps Ortho · 2026

https://510kreport.com/device/K073312 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073312: Osteotrans-OT Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073312

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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