510(k) Report

510(k) · Cleared

Cleared

Bioactif Osteotrans Interfence Screw

K081390510(k) TraditionalCleared Aug 12, 200885-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 Aug 12, 2008 as substantially equivalent to K003641 (Biocomposites, Ltd., 2001) and 3 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1997.

Decided
Aug 12, 2008
Review
85 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K971358 (1997). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors2000: 2 other ancestorsK971358 · Bio-Interference Screw, 7 MM, 8 MM, 9 MM · Arthrex, Inc. · 1997K990454 · Bio-Interference Screw · Innovasive Devices, Inc. · 1999K993975 · Absolute Absorbable Interference Screw · Innovasive Devices, Inc. · 1999K013572 · Mitek Biocryl Interference Screws · Mitek Products · 20021995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K013572 · Mitek Biocryl Interference Screws · Mitek Products · 2002K993975 · Absolute Absorbable Interference Screw · Innovasive Devices, Inc. · 1999K990454 · Bio-Interference Screw · Innovasive Devices, Inc. · 1999K971358 · Bio-Interference Screw, 7 MM, 8 MM, 9 MM · Arthrex, Inc. · 19970
  1. Root · 4 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
  2. 3 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
  3. 2 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
  4. 1 generation backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
  5. This deviceK081390 Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K971358Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc.1997—
−3K990454Bio-Interference ScrewInnovasive Devices, Inc.1999—
−2K993975Absolute Absorbable Interference ScrewInnovasive Devices, Inc.1999—
−1K013572Mitek Biocryl Interference ScrewsMitek Products2002—
0 (this device)K081390Bioactif Osteotrans Interfence ScrewTakiron Co., Ltd.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020
200120
FIG. 1 — Lineage of K081390, 1997–2008Source: 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? (4)

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
*K003641Biolok Screw, Biosteon Screw
Summary page 1
…ion Number: Takiron Co., Ltd. has not yet obtained an Establishment Registration Number. Legally Marketed Predicate Devices: 1. Biocomposites Ltd.; Biosteon T Screw (K003641) 2. Biocomposites Ltd.; Biol-ok® Screw (K002070) 3. Mitek Products; Mitek BiocryllInterference Screw (K013572) 4. Smith &…
Biocomposites, Ltd.2001—
*K002070Biolok Screw
Summary page 1
…an Establishment Registration Number. Legally Marketed Predicate Devices: 1. Biocomposites Ltd.; Biosteon T Screw (K003641) 2. Biocomposites Ltd.; Biol-ok® Screw (K002070) 3. Mitek Products; Mitek BiocryllInterference Screw (K013572) 4. Smith & Nephew Inc.; Smith & Nephew HAPLA Interference Sc…
Biocomposites, Ltd.2000—
*K013572Mitek Biocryl Interference Screws
Summary page 1
…ate Devices: 1. Biocomposites Ltd.; Biosteon T Screw (K003641) 2. Biocomposites Ltd.; Biol-ok® Screw (K002070) 3. Mitek Products; Mitek BiocryllInterference Screw (K013572) 4. Smith & Nephew Inc.; Smith & Nephew HAPLA Interference Screw (K002274) Intended Use: The BioactlF OSTEOTRANSTM Interfere…
Mitek Products2002—
*K002274Smith & Nephew Suture Hapla Interference Screw
Summary page 1
…sites Ltd.; Biol-ok® Screw (K002070) 3. Mitek Products; Mitek BiocryllInterference Screw (K013572) 4. Smith & Nephew Inc.; Smith & Nephew HAPLA Interference Screw (K002274) Intended Use: The BioactlF OSTEOTRANSTM Interference Screw is indicated for the fixation of bone-tendon-bone grafts or soft tis…
Smith & Nephew, Inc.2001—

Also cleared against K003641: 3 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 11 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
  • None of the 8 ancestors has a recall.
  • 3 other devices also cite its predicate K003641.

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 BioactlF OSTEOTRANSTM Interference Screw is indicated for the fixation of bone-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.

Indications for use as stated in the FDA summary.

Also cleared against K003641

3 other devices cite the same predicate.

  • K251680Biosteon® ScrewBiocomposites, Ltd. · 2026
  • K050468Triabsorb Composite ScrewAdvanced Biomaterials · 2005
  • K021351Biosteon Cross PinBiocomposites, Ltd. · 20021 recall

More from Takiron Co., Ltd.

6 FDA decisions under this applicant name. See the company

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

Recent decisions in HWC

The HWC category page

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  • 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/K081390 · printed Nov 5, 2026

Cite this page

510(k) Report. “K081390: Bioactif Osteotrans Interfence Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081390

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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