510(k) Report

510(k) · Cleared

Cleared

Inion Hexalon Biodegradable Acl/PCL Screw

K071464510(k) TraditionalCleared Aug 3, 200766-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

Inion OY · HWC Screw, Fixation, Bone

Cleared on Aug 3, 2007 as substantially equivalent to K062466 (Arthrex, Inc., 2006) and 3 other predicates after a 66-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.

Decided
Aug 3, 2007
Review
66 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K943806 (1995). 18 ancestors in all, the oldest K931519 (1994). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2004: 1 other ancestor2005: 1 other ancestor2001: 3 other ancestors1999: 2 other ancestors1998: 2 other ancestors1995: 2 other ancestors1996: 1 other ancestor1994: 1 other ancestor2013: 1 descendant clearedK943806 · Harpoon Suture Anchors · Biomet, Inc. · 1995K012872 · Resorbable Screw Anchor · Arthrotek, Inc. · 2001K041274 · Resorbable Interference Screw · Arthrotek, Inc. · 2004 · recalledK042552 · Bio-Core Interference Screw · Biomet, Inc. · 20041990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 6 other ancestors3 generations back: 6 other ancestors 1 generation forward: 1 descendant K042552 · Bio-Core Interference Screw · Biomet, Inc. · 2004K041274 · Resorbable Interference Screw · Arthrotek, Inc. · 2004 · recalledK012872 · Resorbable Screw Anchor · Arthrotek, Inc. · 2001K943806 · Harpoon Suture Anchors · Biomet, Inc. · 19950
  1. Root · 4 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
  2. 3 generations backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
  3. 2 generations backK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
  4. 1 generation backK042552 Bio-Core Interference ScrewBiomet, Inc. · 2004
  5. This deviceK071464 Inion Hexalon Biodegradable Acl/PCL ScrewInion OY · 2007
  6. Descendant · cites it directly · 0 of its ownK130716 Bioretec Activascrew InterferenceBioretec, Ltd. · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K130716Bioretec Activascrew InterferenceBioretec, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K943806Harpoon Suture AnchorsBiomet, Inc.1995—
−3K012872Resorbable Screw AnchorArthrotek, Inc.2001—
−2K041274Resorbable Interference ScrewArthrotek, Inc.20045
−1K042552Bio-Core Interference ScrewBiomet, Inc.2004—
0 (this device)K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY2007—
+1K130716Bioretec Activascrew InterferenceBioretec, Ltd.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199520
199610
199820
199920
200130
200410
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K071464, 1995–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K062466Arthrex Interference Screw
Summary page 1
…ommon name: Biodegradable Interference Screw Regulation number: 21 CFR 888.3040 Predicate devices Arthrex Interference Screw (K062466) Artbrex Tenodesis Screw Family (K041356) Biomet Bio-Core Interference Screw (K042552)…
Arthrex, Inc.2006—
*K041356Arthrex Tenodesis Screw Family
Summary page 1
…Regulation number: 21 CFR 888.3040 Predicate devices Arthrex Interference Screw (K062466) Artbrex Tenodesis Screw Family (K041356) Biomet Bio-Core Interference Screw (K042552) Biomet Resorbable Interference Screw (K04 1274)…
Arthrex, Inc.2004—
*K042552Bio-Core Interference Screw
Summary page 1
…icate devices Arthrex Interference Screw (K062466) Artbrex Tenodesis Screw Family (K041356) Biomet Bio-Core Interference Screw (K042552) Biomet Resorbable Interference Screw (K04 1274) Conformance with performance standards…
Biomet, Inc.2004—
*K041274Resorbable Interference Screw
Summary page 1
…66) Artbrex Tenodesis Screw Family (K041356) Biomet Bio-Core Interference Screw (K042552) Biomet Resorbable Interference Screw (K04 1274) Conformance with performance standards No applicable mandatory performance standards exist for thi…
Arthrotek, Inc.20045

Also cleared against K062466: 12 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130

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 12 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 3 of the 18 ancestors have a recall of any class.
  • Of its descendants, K130716 (Bioretec, Ltd., 2013) has gone furthest, with 0 descendants of its own.
  • 12 other devices also cite its predicate K062466.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Inion HexalonTM Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

Indications for use as stated in the FDA summary.

Also cleared against K062466

12 other devices cite the same predicate.

  • K180670ICONN Campbell Interference ScrewIconn Orthopedics, LLC · 2018
  • K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC · 2018
  • K133606N8TIVE Acl Anatomic Reconstruction System, N8TIVE Acl Femoral Implant, N8TIVE Acl Tibial Implant, Various…ArthroCare Corporation · 2014
  • K130217Orthopediatrics Acl Reconstructive SystemOrthoPediatrics Corp. · 20133 recalls
  • K112040Arthrex Biocomposite TransfixArthrex, Inc. · 2011
  • K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc. · 20111 recall

More from Inion OY

14 FDA decisions under this applicant name. See the company

  • 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
  • K203105Inion CompressOn ScrewInion OY · 2021
  • K191764Inion BioRestoreInion OY · 2019
  • K151360Inion Spinal Graft Containment SystemInion OY · 2015

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/K071464 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071464: Inion Hexalon Biodegradable Acl/PCL Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071464

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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