510(k) Report

510(k) · Cleared

Cleared

Inion Otps Biodegradable Fixaton System

K030900510(k) TraditionalCleared Jun 19, 200387-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 Jun 19, 2003 as substantially equivalent to K012001 (Bionx Implants, Ltd., 2001) and 2 other predicates after an 87-day review. Its family tree reaches back 4 generations to 1979. 333 later devices descend from it.

Decided
Jun 19, 2003
Review
87 days
Class
Class II
Product code
HWC
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K792022 (1979). 11 ancestors in all. 333 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1997: 2 other ancestors1995: 2 other ancestors1996: 2 other ancestors2006: 3 descendants cleared2005: 4 descendants cleared2013: 9 descendants cleared2015: 10 descendants cleared2008: 5 descendants cleared2018: 16 descendants cleared2019: 28 descendants cleared2017: 15 descendants cleared2011: 5 descendants cleared2020: 25 descendants cleared2024: 37 descendants cleared2025: 31 descendants cleared2014: 18 descendants cleared2021: 24 descendants cleared2012: 3 descendants cleared2022: 24 descendants cleared2026: 36 descendants cleared2016: 7 descendants cleared2023: 28 descendants cleared2007: 2 descendants cleared2009: 3 descendants clearedK792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalledK974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K992947 · Cannulated Smartscrew Models 224540C, 224570C · Bionx Implants, Ltd. · 1999K012001 · Smartscrew · Bionx Implants, Ltd. · 200119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 4 other ancestors 1 generation forward: 8 descendants2 generations forward: 33 descendants3 generations forward: 53 descendants4 generations forward: 67 descendants5 generations forward: 60 descendants6 generations forward: 55 descendants7 generations forward: 20 descendants8 generations forward: 23 descendants9 generations forward: 9 descendants10 generations forward: 3 descendants11 generations forward: 2 descendants K012001 · Smartscrew · Bionx Implants, Ltd. · 2001K992947 · Cannulated Smartscrew Models 224540C, 224570C · Bionx Implants, Ltd. · 1999K974876 · Bionx Distal Radius Screw · Bionx Implants, Inc. · 1998K792022 · Herbert Bone Screw · Zimmer, Inc. · 1979 · recalled0+5+10
  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 backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
  4. 1 generation backK012001 SmartscrewBionx Implants, Ltd. · 2001
  5. This deviceK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
  6. Descendant · cites it directly · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  7. Descendant · 2 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  8. Descendant · 2 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
  9. Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
  10. Descendant · 3 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013

Showing 5 of 333 descendants. See all descendants

Descendants cleared per year

2005: 42006: 32007: 22008: 52009: 32011: 52012: 32013: 92014: 182015: 102016: 72017: 152018: 162019: 282020: 252021: 242022: 242023: 282024: 372025: 312026: 36
2005high 37 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 333 · See all
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · cites it directly306descendants
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 2 generations on217descendants
  • K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 2 generations on94descendants
  • K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
  • K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 3 generations on71descendants
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—
−2K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999—
−1K012001SmartscrewBionx Implants, Ltd.2001—
0 (this device)K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003—
+1K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
+2K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—
+2K083070Toggleloc SystemBiomet Sports Medicine20086
+2K112437Arthrex Fracture SystemArthrex, Inc.2011—
+3K123241Arthrex Fracture PlatesArthrex, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199620
199720
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200540
200630
200720
200850
200930
201150
201230
201390
2014180
2015100
201670
2017150
2018160
2019280
2020250
2021240
2022240
2023280
2024370
2025310
2026360
FIG. 1 — Lineage of K030900, 1979–2026Source: 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
*K012001Smartscrew
Summary page 1
…anel: Orthopedic Regulatory Class: Class I1 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87.-HWC PREDICATE DEVICES (1) Bionx Inc.; Smartscrew (K012001, K003077) (2) Biomet Bone Screw (K964970) Date:20.3.2003…
Bionx Implants, Ltd.2001—
*K003077Smartscrew Model 222006...227510
Summary page 1
…hopedic Regulatory Class: Class I1 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87.-HWC PREDICATE DEVICES (1) Bionx Inc.; Smartscrew (K012001, K003077) (2) Biomet Bone Screw (K964970) Date:20.3.2003…
Bionx Implants, Ltd.2001—
*K964970Biomet Bone Screw
Summary page 1
…I1 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87.-HWC PREDICATE DEVICES (1) Bionx Inc.; Smartscrew (K012001, K003077) (2) Biomet Bone Screw (K964970) Date:20.3.2003…
Biomet, Inc.1997—

Also cleared against K012001: 5 other devices →

What descends from it? (333)

See all 333

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306
K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY201317
K062617Modification to Inion Otps Biodegradable Fixation SystemInion, Ltd.20063
K081392Bioretec Activascrew, Activascrew Cannulated and Activascrew Cannulated with ActivapinBioretec, Ltd.20082
K062980ActivascrewBioretec, Ltd.20061
K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150
K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC20050
K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc.20050

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 24 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
  • 1 of the 11 ancestors has a recall of any class.
  • Of its descendants, K043248 (Arthrex, Inc., 2005) has gone furthest, with 306 descendants of its own.
  • 5 other devices also cite its predicate K012001.

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 OTPS Biodegradable Fixation System is generally intended for maintenance of reduction and fixation of cancellous bone fractures, osteotomies or arthrodeses of the upper extremity, ankle and foot in the presence of appropriate brace andor immobilization.

Specific indications:

Fractures and osteotomies of the malleoli

Ankle fractures

Indications for use as stated in the FDA summary.

Also cleared against K012001

5 other devices cite the same predicate.

  • K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005
  • K043145BI-Cortical Bio-Post and Washer, Model AR-1367BArthrex, Inc. · 20051 recall
  • K042295Smartscrew II, Models 232010, 232012, 232014, 232016, 232018, 232020Linvatec Biomaterials, Ltd. · 2004
  • K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd. · 2004
  • K023022Nugen FX ScrewBionx Implants, Inc. · 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/K030900 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030900: Inion Otps Biodegradable Fixaton System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030900

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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