510(k) Report

510(k) · Cleared

Cleared

Inion Hexalon Biodegradable Acl/PCL Screw

K021280510(k) TraditionalCleared Jul 17, 200286-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, Ltd. · HWC Screw, Fixation, Bone

Cleared on Jul 17, 2002 as substantially equivalent to K973758 (Linvatec Corp., 1998) and 3 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided
Jul 17, 2002
Review
86 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K971358 (1997). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1998: 2 other ancestors2006: 1 descendant clearedK971358 · Bio-Interference Screw, 7 MM, 8 MM, 9 MM · Arthrex, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant K971358 · Bio-Interference Screw, 7 MM, 8 MM, 9 MM · Arthrex, Inc. · 19970
  1. Root · 1 generation backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
  2. This deviceK021280 Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd. · 2002
  3. Descendant · cites it directly · 0 of its ownK060393 Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K060393Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971358Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc.1997—
0 (this device)K021280Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd.2002—
+1K060393Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K021280, 1997–2006Source: 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
*K973758Bioscrew Absorbable Interference Srew
Summary page 1
…: Class I1 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87-HWC PREDICATE DEVICES Linvatec Corporation; BioScrewB Absorbable Interference Screw (K973758) Arthrex, Inc.; The Arthrex Bio-Interference Screw (K971358) Biomet Inc.; Arthrotek Interference Screw (K982497) Sulzer Orthopedi…
Linvatec Corp.1998—
*K971358Bio-Interference Screw, 7 MM, 8 MM, 9 MM
Summary page 1
…e fixation fastener, 87-HWC PREDICATE DEVICES Linvatec Corporation; BioScrewB Absorbable Interference Screw (K973758) Arthrex, Inc.; The Arthrex Bio-Interference Screw (K971358) Biomet Inc.; Arthrotek Interference Screw (K982497) Sulzer Orthopedics Inc.; Sysorb Interference Screw (€383592)…
Arthrex, Inc.1997—
*K982497Arthrotek Interference Screw
Summary page 1
…tec Corporation; BioScrewB Absorbable Interference Screw (K973758) Arthrex, Inc.; The Arthrex Bio-Interference Screw (K971358) Biomet Inc.; Arthrotek Interference Screw (K982497) Sulzer Orthopedics Inc.; Sysorb Interference Screw (€383592)…
Biomet, Inc.19985
*K983592Sulzer Orthopedics Sysorb Interference Screws
Summary page 2
…and BioScrewB Absorbable Interference Screw (K973758), The Arthrex Bio-Interference Screw (K971339, Arthrotek Interference Screw (K982497) and Sysorb Interference screw (K983592) have the same intended use and principles of operation and very similar design characteristics. Mechanical testing demonstratest…
Sulzer Orthopedics, Inc.1999—

Also cleared against K973758: 9 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
K060393Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd.20060

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?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K060393 (Inion, Ltd., 2006) has gone furthest, with 0 descendants of its own.
  • 9 other devices also cite its predicate K973758.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.

Indications for use as stated in the FDA summary.

Also cleared against K973758

9 other devices cite the same predicate.

  • K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials · 2007
  • K051611Mbaresorb ImplantKinetikos Medical, Inc. · 20053 recalls
  • K031939Bio-Eurolig Interference ScrewFournitures Hospitalieres Industrie · 2004
  • K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T…Linvatec Biomaterials, Inc. · 2004
  • K013131Bioscrew XtralokLinvatec Corp. · 20021 recall
  • K013781Rididfix 2.7MM BTB Cross Pin KitMitek Products · 2002

More from Inion, Ltd.

23 FDA decisions under this applicant name. See the company

  • K071810Inion Spinal Graft Containment SystemInion, Ltd. · 2008
  • K063410Inion CPS/Otps FreedomplateInion, Ltd. · 2007
  • K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd. · 2006
  • K060393Inion Hexalon Biodegradable Acl/PCL ScrewInion, Ltd. · 2006
  • K051821Inion S-1 Biodegradable Anterior Cervical Fusion SystemInion, Ltd. · 2005

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/K021280 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021280: 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/K021280

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