510(k) Report

510(k) · Cleared

Cleared

Inion Otps Biodegradable Pin

K031712510(k) TraditionalCleared Aug 28, 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. · HTY Pin, Fixation, Smooth

Cleared on Aug 28, 2003 as substantially equivalent to K010983 (Bionx Implants, Inc., 2001) and 2 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1990. 382 later devices descend from it.

Decided
Aug 28, 2003
Review
87 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K901456 (1990). 3 ancestors in all. 382 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1997: 1 other ancestor2008: 7 descendants cleared2004: 1 descendant cleared2006: 3 descendants cleared2009: 5 descendants cleared2014: 25 descendants cleared2005: 4 descendants cleared2015: 16 descendants cleared2019: 31 descendants cleared2007: 3 descendants cleared2017: 19 descendants cleared2018: 18 descendants cleared2016: 9 descendants cleared2013: 8 descendants cleared2011: 5 descendants cleared2020: 27 descendants cleared2024: 43 descendants cleared2025: 34 descendants cleared2021: 24 descendants cleared2012: 3 descendants cleared2022: 25 descendants cleared2026: 39 descendants cleared2023: 33 descendants clearedK901456 · Orthosorb (R) Absorbable Pin · Johnson & Johnson International · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 18 descendants3 generations forward: 47 descendants4 generations forward: 65 descendants5 generations forward: 69 descendants6 generations forward: 66 descendants7 generations forward: 56 descendants8 generations forward: 21 descendants9 generations forward: 20 descendants10 generations forward: 8 descendants11 generations forward: 3 descendants12 generations forward: 2 descendants K901456 · Orthosorb (R) Absorbable Pin · Johnson & Johnson International · 19900+5+10
  1. Root · 1 generation backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
  2. This deviceK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
  3. Descendant · cites it directly · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
  4. Descendant · 2 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  5. Descendant · 3 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  6. Descendant · 3 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
  7. Descendant · 3 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011

Showing 5 of 382 descendants. See all descendants

Descendants cleared per year

2004: 12005: 42006: 32007: 32008: 72009: 52011: 52012: 32013: 82014: 252015: 162016: 92017: 192018: 182019: 312020: 272021: 242022: 252023: 332024: 432025: 342026: 39
2004high 43 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 382 · See all
  • K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · cites it directly309descendants
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 2 generations on306descendants
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 3 generations on217descendants
  • K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 3 generations on94descendants
  • K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 3 generations on91descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901456Orthosorb (R) Absorbable PinJohnson & Johnson International1990—
0 (this device)K031712Inion Otps Biodegradable PinInion, Ltd.2003—
+1K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004—
+2K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
+3K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—
+3K083070Toggleloc SystemBiomet Sports Medicine20086
+3K112437Arthrex Fracture SystemArthrex, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200540
200630
200730
200870
200950
201150
201230
201380
2014250
2015160
201690
2017190
2018180
2019310
2020270
2021240
2022250
2023330
2024430
2025340
2026390
FIG. 1 — Lineage of K031712, 1990–2026Source: 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 HTY? 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 HTY device

  1. #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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
*K010983Plla Pin
Summary page 1
…latory Class: Class I1 21 (IFR 888.3040 - Smooth or threaded metallic bone fixation fastener, 87-HWC PREDICATE DEVICES Biorix Implants, Inc.;PLLA Pin (K010983) DePuy ACE; Orthosorb Absorbable Pin (K901456) Synl hes; Polypin (K96 1608) Pin…
Bionx Implants, Inc.2001—
*K901456Orthosorb (R) Absorbable Pin
Summary page 1
…th or threaded metallic bone fixation fastener, 87-HWC PREDICATE DEVICES Biorix Implants, Inc.;PLLA Pin (K010983) DePuy ACE; Orthosorb Absorbable Pin (K901456) Synl hes; Polypin (K96 1608) Pin Date: 20.5.2003…
Johnson & Johnson International1990—
*K961608Synthes (U.S.a.) Polypin
Summary page 1
…ion fastener, 87-HWC PREDICATE DEVICES Biorix Implants, Inc.;PLLA Pin (K010983) DePuy ACE; Orthosorb Absorbable Pin (K901456) Synl hes; Polypin (K96 1608) Pin Date: 20.5.2003…
Synthes (Usa)1997—

Also cleared against K010983: 3 other devices →

What descends from it? (382)

See all 382

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

NumberDeviceApplicantDecidedDescendants
K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309
K050275Modification to: Inion Otps Biodegradable PinInion, Ltd.200551
K061164ActivapinBioretec, Ltd.200637
K090160Suprathel Wound and Burn DressingPolymedics Innovations, GmbH200918
K133477Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical20149
K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC20051
K073311Osteotrans-OT PinTakiron Co., Ltd.20080

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K033717 (Bonutti Research, Inc., 2004) has gone furthest, with 309 descendants of its own.
  • 3 other devices also cite its predicate K010983.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTY

5in 2025

2007: 62008: 62009: 22010: 92011: 62012: 42013: 42014: 82015: 82016: 62017: 52018: 42019: 42020: 52021: 52022: 42023: 52024: 12025: 52026 (partial year): 2
2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007: 112 days median2008: 86 days median2010: 180 days median2011: 82 days median2012: 76 days median2013: 128 days median2014: 73 days median2015: 101 days median2016: 114 days median2017: 127 days median2018: 162 days median2019: 93 days median2020: 108 days median2021: 137 days median2022: 121 days median2023: 146 days median2025: 90 days median
2007high 180 (2010) · low 73 (2014)2026

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

Recalls per year · HTY

2in 2022

2009: 12010: 12016: 22019: 12022: 22026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

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

Adverse event reports per year · HTY

39in 2025

2007: 462008: 382009: 362010: 332011: 1642012: 1292013: 1872014: 1492015: 1212016: 1282017: 822018: 1382019: 2222020: 2102021: 1482022: 962023: 1532024: 2972025: 39
2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, 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
20076112046
2008686038
20092—136
20109180133
20116820164
20124760129
201341280187
20148730149
201581010121
201661142128
20175127082
201841620138
20194931222
202051080210
202151370148
20224121296
202351460153
20241—0297
2025590039
20262—1—

What is it indicated for?

The Inion OTPSTM Biodegradable Pin is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Indications for use as stated in the FDA summary.

Also cleared against K010983

3 other devices cite the same predicate.

  • K073311Osteotrans-OT PinTakiron Co., Ltd. · 2008
  • K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LGXtremi-T, LLC · 2005
  • K041288Modification to SmartpinLinvatec Biomaterials, Inc. · 2004

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 HTY

The HTY category page

  • K262126Cerclage Wires;K-wires;Steinmann PinsMK Medical GmbH · 2026
  • K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
  • K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions · 2025
  • K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc. · 2025
  • K250315Ronavis – FX (FX-001)AIRS, Inc. · 2025

https://510kreport.com/device/K031712 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031712: Inion Otps Biodegradable Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031712

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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